F02.15 - Chemical/Safety Properties

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.  
5.2 This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.  
5.3 Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.  
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.  
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.  
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.  
1.7 The values stated in SI units are to be regarded as the standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is of particular use as a quality control tool for a molding or synthesis operation. Acetaldehyde is a volatile degradation product generated during melt processing of PET. Thus, it becomes trapped in the sidewalls of a molded article and desorbs slowly into the contents packaged therein. In some foods and beverages AA can impart an off-taste that is undesirable, thus, it is important to know its concentration in PET articles that are to be used in food contact applications.  
5.2 The desorption conditions of 150 °C for 60 min are such that no measurable AA is generated by the sample during the desorption process.
SCOPE
1.1 This test method covers a gas chromatographic procedure for the determination of the ppm residual acetaldehyde (AA) present in poly(ethylene terephthalate) (PET) homo-polymers and co-polymers which are used in the manufacture of beverage bottles. This includes sample types of both amorphous and solid-stated pellet and preform samples, as opposed to the bottle test, Test Method D4509, an acetaldehyde test requiring 24 h of desorption time at 23 °C into the bottle headspace and then the concentration of the headspace quantified by a similar GC method.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.  
5.2 Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.  
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds, the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy, or other techniques in conjunction with this test method.  
1.5 A sensitivity level of approximately 0.025 μg/in.2 is achievable for the compounds studied in Table 1. Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E260 for procedures on determining sensitivity of chromatographic methods.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.  
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal.4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.  
6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.  
6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
FIG. 1 A Typical Curve Showing Penetration as a Function of Flow Rate
Note 1: The point of maximum penetration is indicated by the upward pointing triangle.  
6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC) (2942 Pa). This test method is based upon the research of Tallentire and Sinclair4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.  
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.  
1.3 The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs.  
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:  
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.  
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.  
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).  
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.  
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.  
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.  
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or on the human body, the benefits of these devices must outweigh the risks. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical, or biological properties of the device. This evaluation may include both a study of relevant experience with, and actual testing of, packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.  
5.2 The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed.
SCOPE
1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly.  
1.2 This guide does not apply to secondary or tertiary packaging materials.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
3.1 Expiration dates are often marked on the packages of perishable products to indicate the presumed end of their shelf lives. Since the shelf lives of most perishable products are temperature dependent, the expiration date is determined by assuming the product will be kept within a prescribed temperature range for its entire life. A problem with this method is that there is no way to determine if the shelf life of a product has been shortened by exposure to a higher temperature. A time-temperature indicator solves this problem when attached to the package because it reaches its end point sooner when exposed to a higher temperature.  
3.2 In order to directly indicate the end of the shelf life, the time-temperature indicator characteristics should be matched as closely as possible to the quality characteristics of the product. When kept at the standard storage temperature for the product, the indicator should reach its end point at the same time as the product's shelf life. In addition, to determine the accuracy of the match at other temperatures, the change of shelf life with temperature should be known for both the product and the indicator. The Arrhenius relationship is a common and convenient method of describing the change of shelf life with temperature. In cases where it is not applicable, individual time-temperature points for the product may be established and an approximate correlation with the TTI obtained.  
3.3 When attached to the package of a perishable product, a time-temperature indicator may supplement, or in some cases replace, the expiration date code. The addition of a TTI provides a greater level of confidence that the perishable product is within its shelf life because it responds to the actual temperature conditions to which the product has been exposed.  
3.4 In the case of minimally processed refrigerated foods, the rapid growth of pathogenic bacteria at elevated temperatures may pose a serious health hazard even before the deterioration...
SCOPE
1.1 This guide covers information on the selection of commercially available time-temperature indicators (TTIs) for noninvasive external package use on perishable products, such as food and pharmaceuticals. When attached to the package of a perishable product, TTIs are used to measure the combined time and temperature history of the product in order to predict the remaining shelf life of the product or to signal the end of its usable shelf life. It is the responsibility of the processor of the perishable product to determine the shelf life of a product at the appropriate temperatures and to consult with the indicator manufacturer to select the available indicator which most closely matches the quality of the product as a function of time and temperature.  
Note 1: Besides time-temperature indicator, TTI is also an abbreviation for time-temperature monitor and time-temperature integrator.  
1.2 Time-temperature indicators may be integrated into a Hazard Analysis and Critical Control Point (HACCP) plan. Appropriate instructions should be established for handling products for which either the indicator has signaled the end of usable shelf life or the shelf life of the product at its normal storage temperature has been reached.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal.4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.  
6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.  
6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
FIG. 1 A Typical Curve Showing Penetration as a Function of Flow Rate
Note 1: The point of maximum penetration is indicated by the upward pointing triangle.  
6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC) (2942 Pa). This test method is based upon the research of Tallentire and Sinclair4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.  
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.  
1.3 The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs.  
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.  
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.  
5.2 Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.  
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds, the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy, or other techniques in conjunction with this test method.  
1.5 A sensitivity level of approximately 0.025 μg/in.2 is achievable for the compounds studied in Table 1. Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E260 for procedures on determining sensitivity of chromatographic methods.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.  
5.2 This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.  
5.3 Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.  
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.  
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.  
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.  
1.7 The values stated in SI units are to be regarded as the standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is of particular use as a quality control tool for a molding or synthesis operation. Acetaldehyde is a volatile degradation product generated during melt processing of PET. Thus, it becomes trapped in the sidewalls of a molded article and desorbs slowly into the contents packaged therein. In some foods and beverages AA can impart an off-taste that is undesirable, thus, it is important to know its concentration in PET articles that are to be used in food contact applications.  
5.2 The desorption conditions of 150 C for 60 min are such that no measurable AA is generated by the sample during the desorption process.
SCOPE
1.1 This test method covers a gas chromatographic procedure for the determination of the ppm residual acetaldehyde (AA) present in poly(ethylene terephthalate) (PET) homo-polymers and co-polymers which are used in the manufacture of beverage bottles. This includes sample types of both amorphous and solid-stated pellet and preform samples, as opposed to the bottle test, Test Method D4509, an acetaldehyde test requiring 24 h of desorption time at 23°C into the bottle headspace and then the concentration of the headspace quantified by a similar GC method.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:  
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.  
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.  
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).  
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.  
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.  
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.  
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method establishes the apparatuses required, the standard procedures, and associated calculations involved in the determination of relatively polar nonvolatile ultraviolet (UV) absorbing extractable components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812. This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor.
SCOPE
1.1 This test method covers the determination of nonpolar and relatively polar ultraviolet (UV) absorbing components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812.  
1.2 This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor. Adhesive and PETE related compounds were quantitated using this test method.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in 4.3.2.3.

SIGNIFICANCE AND USE
5.1 This test method was developed to measure non-UV-absorbing nonvolatile extractables that may be present and migrate from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of non-UV-absorbing nonvolatile extractables either through susceptor design or manufacturing processes.  
5.2 Supplementation of this procedure with other analytical technologies such as high-pressure liquid chromatography, supercritical fluid chromatography, or infrared or other forms of spectroscopy may provide the analyst with additional information regarding the identification of the components of the non-UV-absorbing nonvolatile extractables in the susceptor.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.  
1.2 This test method covers a procedure for quantitating non-UV-absorbing nonvolatile compounds which are extractable when the microwave susceptor is tested under simulated use conditions for a particular food product.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
3.1 Expiration dates are often marked on the packages of perishable products to indicate the presumed end of their shelf lives. Since the shelf lives of most perishable products are temperature dependent, the expiration date is determined by assuming the product will be kept within a prescribed temperature range for its entire life. A problem with this method is that there is no way to determine if the shelf life of a product has been shortened by exposure to a higher temperature. A time-temperature indicator solves this problem when attached to the package because it reaches its end point sooner when exposed to a higher temperature.  
3.2 In order to directly indicate the end of the shelf life, the time-temperature indicator characteristics should be matched as closely as possible to the quality characteristics of the product. When kept at the standard storage temperature for the product, the indicator should reach its end point at the same time as the product's shelf life. In addition, to determine the accuracy of the match at other temperatures, the change of shelf life with temperature should be known for both the product and the indicator. The Arrhenius relationship is a common and convenient method of describing the change of shelf life with temperature. In cases where it is not applicable, individual time-temperature points for the product may be established and an approximate correlation with the TTI obtained.  
3.3 When attached to the package of a perishable product, a time-temperature indicator may supplement, or in some cases replace, the expiration date code. The addition of a TTI provides a greater level of confidence that the perishable product is within its shelf life because it responds to the actual temperature conditions to which the product has been exposed.  
3.4 In the case of minimally processed refrigerated foods, the rapid growth of pathogenic bacteria at elevated temperatures may pose a serious health hazard even before the deterioratio...
SCOPE
1.1 This guide covers information on the selection of commercially available time-temperature indicators (TTIs) for noninvasive external package use on perishable products, such as food and pharmaceuticals. When attached to the package of a perishable product, TTIs are used to measure the combined time and temperature history of the product in order to predict the remaining shelf life of the product or to signal the end of its usable shelf life. It is the responsibility of the processor of the perishable product to determine the shelf life of a product at the appropriate temperatures and to consult with the indicator manufacturer to select the available indicator which most closely matches the quality of the product as a function of time and temperature. Note 1—Besides time-temperature indicator, TTI is also an abbreviation for time-temperature monitor and time-temperature integrator.  
1.2 Time-temperature indicators may be integrated into a Hazard Analysis and Critical Control Point (HACCP) plan. Appropriate instructions should be established for handling products for which either the indicator has signaled the end of usable shelf life or the shelf life of the product at its normal storage temperature has been reached.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 This test method is intended to identify volatile extractables that may be emitted from microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount and type of volatile extractables produced. The susceptor design, materials used or manufacturing processes involved can be evaluated.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.  
1.2 This test method covers a procedure for identifying volatile extractables which are released when a microwave susceptor sample is tested under simulated end use conditions. The extractables are identified using gas chromatography/mass spectrometry (GC/MS).  
1.3 This test method was evaluated for the identification of a variety of volatile extractables at a level of 0.010 μg/in.2 of susceptor surface. For extractables not evaluated, the analyst should perform studies to determine the level of extractable at which identification is achievable.  
1.4 The analyst is encouraged to run known volatile extractables and/or incorporate techniques such as gas chromatography/high resolution mass spectrometry (GC/HRMS), gas chromatography/infrared spectroscopy (GC/IR) or other techniques to aid in verifying the identity of or identifying unknown volatile extractables. The analyst is referred to Practice E260 for additional guidance.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method covers the standard procedures for measuring and profiling surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). This procedure is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used in the temperature profiling of susceptors exposed in vials used for volatile extractives testing, or in liquid (PTFE-fluorocarbon polymer) extraction cells used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.
SCOPE
1.1 This is a test method for measuring surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). It is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used to measure the temperature of a susceptor exposed to extractives testing or in a liquid extraction cell to be used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.  
1.1.1 Several of the steps of this test method are taken directly from Test Method F1308 which gives extraction testing procedures for susceptors.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.  
5.2 Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.  
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds, the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy, or other techniques in conjunction with this test method.  
1.5 A sensitivity level of approximately 0.025 μg/in.2 is achievable for the compounds studied in Table 1. Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E260 for procedures on determining sensitivity of chromatographic methods.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.

SIGNIFICANCE AND USE
5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.  
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method covers the apparatuses required, and standard procedures and calculations involved in the calibration of microwave ovens designed for both home and commercial use. It was developed for use in the evaluation of volatile and nonvolatile components of microwave susceptor packages. There are, however, no recognized standards by which to estimate bias of this test method.
SCOPE
1.1 This test method is applicable to microwave ovens designed for both home and commercial use. It was developed for use in the evaluation of volatile and nonvolatile components of microwave susceptor packages.  
1.2 This test method was collaboratively evaluated with microwave ovens with nominal output ratings of 700 W.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal.4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.  
6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.  
6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
Note 1: The point of maximum penetration is indicated by the upward pointing triangle.  
6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC). This test method is based upon the research of Tallentire and Sinclair4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.  
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.  
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636–3.  
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal. This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.
This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.
When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC). This test method is based upon the research of Tallentire and Sinclair and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636–3.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.
The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.
SCOPE
1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.
This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.
Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.
1.7 The values stated in SI units are to be regarded as the standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is of particular use as a quality control tool for a molding or synthesis operation. Acetaldehyde is a volatile degradation product generated during melt processing of PET. Thus, it becomes trapped in the sidewalls of a molded article and desorbs slowly into the contents packaged therein. In some foods and beverages AA can impart an off-taste that is undesirable, thus, it is important to know its concentration in PET articles that are to be used in food contact applications.
The desorption conditions of 150 C for 60 min are such that no measurable AA is generated by the sample during the desorption process.
SCOPE
1.1 This test method covers a gas chromatographic procedure for the determination of the ppm residual acetaldehyde (AA) present in poly(ethylene terephthalate) (PET) homo-polymers and co-polymers which are used in the manufacture of beverage bottles. This includes sample types of both amorphous and solid-stated pellet and preform samples, as opposed to the bottle test, Test Method D4509, an acetaldehyde test requiring 24 h of desorption time at 23°C into the bottle headspace and then the concentration of the headspace quantified by a similar GC method.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test are useful in assessing the relative potential of a particular porous material to contribute to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:
The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.
The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.
The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).
The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the LRV. Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be condsidered adequate for purposes of setting performance standards.
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method establishes the apparatus required, the standard procedures, and associated calculations involved in the determination of relatively polar nonvolatile ultraviolet (UV) absorbing extractable components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812. This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor.
SCOPE
1.1 This test method covers the determination of nonpolar and relatively polar ultraviolet (UV) absorbing components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812.
1.2 This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor. Adhesive and PETE related compounds were quantitated using this test method.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in 4.3.2.3.

ABSTRACT
This test method covers the standard procedures for measuring and profiling surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). This procedure is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used in the temperature profiling of susceptors exposed in vials used for volatile extractives testing, or in liquid (PTFE-fluorocarbon polymer) extraction cells used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.
SCOPE
1.1 This is a test method for measuring surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). It is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used to measure the temperature of a susceptor exposed to extractives testing or in a liquid extraction cell to be used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.
1.1.1 Several of the steps of this test method are taken directly from Test Method F 1308 which gives extraction testing procedures for susceptors.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.
Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.  
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. The analyst is referred to Practice E 260 for guidance.
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds, the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy, or other techniques in conjunction with this test method.
1.5 A sensitivity level of approximately 0.025 μg/in. is achievable for the compounds studied in Table 1. Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E 260 for procedures on determining sensitivity of chromatographic methods.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.
TABLE 1 Analyte Recovery Without Microwaving   Compound(n)ARecovery Mean, %Within Laboratory Variability, %Overall Variability, %Note(s)B Benzene 5 97.7 7.8 9.0 2-Butoxy-ethanol4 98.7 6.7 8.41 Dibutyl Ether5109.716.5 23.7 Dodecane3101.110.7 10.71, 2 2-Furfural4 99.711.7 12.01 Furan-
2-Methanol3 100.014.116.41, 3 Isobutyl Alcohol4 96.0 7.1 7.94 Methylene
Chloride5 103.516.722.6 2-Propanol3 99.911.4 12.04 Styrene 5100.8 8.5 9.3 Toluene 4102.7 9.910.94 Overall101.1 11.614.4
A n = number of laboratories submitting data on compound.
B Notes: Collaborating laboratories provided the following reasons for not sub-
mitting data on a particular analyte:
1. The analyst felt interaction was occurring among various analytes and spent several days investigating. The laboratory manager refused to allow additional time for collaborative study.
2. The analyst questioned the solubility of the analyte and did not add to the spike mixture.
3. A fresh standard was not prepared fresh daily. This compound degrades measurably in water in 24 h.
4. The analyst experienced coelution of peaks under conditions of collaborative study on his/her particular system.

SIGNIFICANCE AND USE
Expiration dates are often marked on the packages of perishable products to indicate the presumed end of their shelf lives. Since the shelf lives of most perishable products are temperature dependent, the expiration date is determined by assuming the product will be kept within a prescribed temperature range for its entire life. A problem with this method is that there is no way to determine if the shelf life of a product has been shortened by exposure to a higher temperature. A time-temperature indicator solves this problem when attached to the package because it reaches its end point sooner when exposed to a higher temperature.
In order to directly indicate the end of the shelf life, the time-temperature indicator characteristics should be matched as closely as possible to the quality characteristics of the product. When kept at the standard storage temperature for the product, the indicator should reach its end point at the same time as the product's shelf life. In addition, to determine the accuracy of the match at other temperatures, the change of shelf life with temperature should be known for both the product and the indicator. The Arrhenius relationship is a common and convenient method of describing the change of shelf life with temperature. In cases where it is not applicable, individual time-temperature points for the product may be established and an approximate correlation with the TTI obtained.
When attached to the package of a perishable product, a time-temperature indicator may supplement, or in some cases replace, the expiration date code. The addition of a TTI provides a greater level of confidence that the perishable product is within its shelf life because it responds to the actual temperature conditions to which the product has been exposed.
In the case of minimally processed refrigerated foods, the rapid growth of pathogenic bacteria at elevated temperatures may pose a serious health hazard even before the deterioration of the quality of ...
SCOPE
1.1 This guide covers information on the selection of commercially available time-temperature indicators (TTIs) for noninvasive external package use on perishable products, such as food and pharmaceuticals. When attached to the package of a perishable product, TTIs are used to measure the combined time and temperature history of the product in order to predict the remaining shelf life of the product or to signal the end of its usable shelf life. It is the responsibility of the processor of the perishable product to determine the shelf life of a product at the appropriate temperatures and to consult with the indicator manufacturer to select the available indicator which most closely matches the quality of the product as a function of time and temperature.
Note 1—Besides time-temperature indicator, TTI is also an abbreviation for time-temperature monitor and time-temperature integrator.  
1.2 Time-temperature indicators may be integrated into a Hazard Analysis and Critical Control Point (HACCP) plan. Appropriate instructions should be established for handling products for which either the indicator has signaled the end of usable shelf life or the shelf life of the product at its normal storage temperature has been reached.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is intended to identify volatile extractables that may be emitted from microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount and type of volatile extractables produced. The susceptor design, materials used or manufacturing processes involved can be evaluated.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.
1.2 This test method covers a procedure for identifying volatile extractables which are released when a microwave susceptor sample is tested under simulated end use conditions. The extractables are identified using gas chromatography/mass spectrometry (GC/MS).
1.3 This test method was evaluated for the identification of a variety of volatile extractables at a level of 0.010 μg/in.2 of susceptor surface. For extractables not evaluated, the analyst should perform studies to determine the level of extractable at which identification is achievable.
1.4 The analyst is encouraged to run known volatile extractables and/or incorporate techniques such as gas chromatography/high resolution mass spectrometry (GC/HRMS), gas chromatography/infrared spectroscopy (GC/IR) or other techniques to aid in verifying the identity of or identifying unknown volatile extractables. The analyst is referred to Practice E 260 for additional guidance.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method was developed to measure non-UV-absorbing nonvolatile extractables that may be present and migrate from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of non-UV-absorbing nonvolatile extractables either through susceptor design or manufacturing processes.
Supplementation of this procedure with other analytical technologies such as high-pressure liquid chromatography, supercritical fluid chromatography, or infrared or other forms of spectroscopy may provide the analyst with additional information regarding the identification of the components of the non-UV-absorbing nonvolatile extractables in the susceptor.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.
1.2 This test method covers a procedure for quantitating non-UV-absorbing nonvolatile compounds which are extractable when the microwave susceptor is tested under simulated use conditions for a particular food product.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 m particles and assessing the filtration efficiency of the material using either single or dual particle counters.
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636-3.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.
SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method covers the apparatus required, and standard procedures and calculations involved in the calibration of microwave ovens designed for both home and commercial use. It was developed for use in the evaluation of volatile and nonvolatile components of microwave susceptor packages. There are, however, no recognized standards by which to estimate bias of this test method.
SCOPE
1.1 This test method is applicable to microwave ovens designed for both home and commercial use. It was developed for use in the evaluation of volatile and nonvolatile components of microwave susceptor packages.
1.2 This test method was collaboratively evaluated with microwave ovens with nominal output ratings of 700 W.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.
The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.
SCOPE
1.1 This guide provides information to determine the appropriate testing for biocompatibility of packaging materials used to contain a medical device.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is of particular use as a quality control tool for a molding or synthesis operation. Acetaldehyde is a volatile degradation product generated during melt processing of PET. Thus, it becomes trapped in the sidewalls of a molded article and desorbs slowly into the contents packaged therein. In some foods and beverages AA can impart an off-taste that is undesirable, thus, it is important to know its concentration in PET articles that are to be used in food contact applications.
The desorption conditions of 150 C for 60 min are such that no measurable AA is generated by the sample during the desorption process.
SCOPE
1.1 This test method covers a gas chromatographic procedure for the determination of the ppm residual acetaldehyde (AA) present in poly(ethylene terephthalate) (PET) homo-polymers and co-polymers which are used in the manufacture of beverage bottles. This includes sample types of both amorphous and solid-stated pellet and preform samples, as opposed to the bottle test, Test Method D 4509, an acetaldehyde test requiring 24 h of desorption time at 23°C into the bottle headspace and then the concentration of the headspace quantified by a similar GC method.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test are useful in assessing the relative potential of a particular porous material to contribute to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.  
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the LRV. Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be condsidered adequate for purposes of setting performance standards.  
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.
This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.
Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F 151.
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.
1.7 The values stated in SI units are to be regarded as the standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This test method is applicable to microwave ovens designed for both home and commercial use. It was developed for use in the evaluation of volatile and nonvolatile components of microwave susceptor packages.
1.2 This test method was collaboratively evaluated with microwave ovens with nominal output ratings of 700 W.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.
Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. The analyst is referred to Practice E 260 for guidance.
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds, the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy, or other techniques in conjunction with this test method.
1.5 A sensitivity level of approximately 0.025 g/in. is achievable for the compounds studied in . Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E 260 for procedures on determining sensitivity of chromatographic methods.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.

ABSTRACT
This test method establishes the apparatuses required, the standard procedures, and associated calculations involved in the determination of relatively polar nonvolatile ultraviolet (UV) absorbing extractable components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812. This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor.
SCOPE
1.1 This test method covers the determination of relatively polar ultraviolet (UV) absorbing components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812.
1.2 This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor. Adhesive and PETE related compounds were quantitated using this test method.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in 4.3.2.3.

SIGNIFICANCE AND USE
This test method is intended to identify volatile extractables that may be emitted from microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount and type of volatile extractables produced. The susceptor design, materials used or manufacturing processes involved can be evaluated.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.
1.2 This test method covers a procedure for identifying volatile extractables which are released when a microwave susceptor sample is tested under simulated end use conditions. The extractables are identified using gas chromatography/mass spectrometry (GC/MS).
1.3 This test method was evaluated for the identification of a variety of volatile extractables at a level of 0.010 g/in. of susceptor surface. For extractables not evaluated, the analyst should perform studies to determine the level of extractable at which identification is achievable.
1.4 The analyst is encouraged to run known volatile extractables and/or incorporate techniques such as gas chromatography/high resolution mass spectrometry (GC/HRMS), gas chromatography/infrared spectroscopy (GC/IR) or other techniques to aid in verifying the identity of or identifying unknown volatile extractables. The analyst is referred to Practice E 260 for additional guidance.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method was developed to measure non-UV-absorbing nonvolatile extractables that may be present and migrate from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of non-UV-absorbing nonvolatile extractables either through susceptor design or manufacturing processes.
Supplementation of this procedure with other analytical technologies such as high-pressure liquid chromatography, supercritical fluid chromatography, or infrared or other forms of spectroscopy may provide the analyst with additional information regarding the identification of the components of the non-UV-absorbing nonvolatile extractables in the susceptor.
SCOPE
1.1 This test method is applicable to complete microwave susceptors.
1.2 This test method covers a procedure for quantitating non-UV-absorbing nonvolatile compounds which are extractable when the microwave susceptor is tested under simulated use conditions for a particular food product.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method covers the standard procedures for measuring and profiling surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). This procedure is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used in the temperature profiling of susceptors exposed in vials used for volatile extractives testing, or in liquid (PTFE-fluorocarbon polymer) extraction cells used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.
SCOPE
1.1 This is a test method for measuring surface temperatures attained by microwave interactive packaging and cooking aids (that is, susceptors). It is useful for measuring susceptor/food interface temperatures during microwave preparation of foods with susceptor-based packaging, heating pads, and crisping sleeves, etc. It may also be used to measure the temperature of a susceptor exposed to extractives testing or in a liquid extraction cell to be used for nonvolatile extractives testing. The latter procedures are performed to establish test conditions for conducting extraction and migration studies using temperature versus time profiles approximating those for actual microwave preparation of the product.
1.1.1 Several of the steps of this test method are taken directly from Test Method F 1308 which gives extraction testing procedures for susceptors.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This guide covers information on the selection of commercially available time-temperature indicators (TTIs) for noninvasive external package use on perishable products, such as food and pharmaceuticals. When attached to the package of a perishable product, TTIs are used to measure the combined time and temperature history of the product in order to predict the remaining shelf life of the product or to signal the end of its usable shelf life. It is the responsibility of the processor of the perishable product to determine the shelf life of a product at the appropriate temperatures and to consult with the indicator manufacturer to select the available indicator which most closely matches the quality of the product as a function of time and temperature.
Note 1—Besides time-temperature indicator, TTI is also an abbreviation for time-temperature monitor and time-temperature integrator.
1.2 Time-temperature indicators may be integrated into a Hazard Analysis and Critical Control Point (HACCP) plan. Appropriate instructions should be established for handling products for which either the indicator has signaled the end of usable shelf life or the shelf life of the product at its normal storage temperature has been reached.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This test method establishes the apparatuses required, the standard procedures, and associated calculations involved in the determination of relatively polar nonvolatile ultraviolet (UV) absorbing extractable components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812. This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor.
SCOPE
1.1 This test method covers the determination of nonpolar and relatively polar ultraviolet (UV) absorbing components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812.  
1.2 This test method has been collaboratively studied using bilaminate susceptors constructed of paperboard, adhesive, and a layer of polyethylene terephthalate polymer (PETE) susceptor. Adhesive and PETE related compounds were quantitated using this test method.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in 4.3.2.3.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
WITHDRAWN RATIONALE
This test method covered the determination of nonpolar and relatively polar ultraviolet (UV) absorbing components that may migrate from microwave susceptor packaging into food simulants, such as corn oil and Miglyol 812.
Formerly under the jurisdiction of Committee F02 on Primary Barrier Packaging, this test method was withdrawn in April 2024. This standard is being withdrawn without replacement due to its limited use by industry.