F02.50 - Package Design and Development

SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.  
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 This practice is valuable in determining the resistance of flexible packaging materials to flex-formed pinholes. Conditioning levels A, B, or C are typically used. Reference Practice E171 and Guide F2097.  
5.2 Conditions D and E are typically used for determining the effect of flexing on barrier properties and transmission rates related to gas and/or moisture.  
5.3 This practice does not measure or condition materials for abrasion related to flex failure.  
5.4 Failures in the integrity of one or more of the plies of a multi-ply structure may require alternative testing. Supplementary permeation testing using gas or water vapor can be used in conjunction with the flex conditioning to measure the loss of ply integrity. Other test methods may be used after flexing for assessment of presence of pinholes. For a list of test methods, refer to Guide F2097.
FIG. 1 Planar Evolution of Gelbo Shaft Helical Groove 30.70 mm [1.20 in.] Diameter Shaft  
5.4.1 The various conditions described in this practice are to prevent evaluating a material structure with an outcome of too many holes to effectively count (normally greater than 50), or too few to be significant (normally less than five per sample). Material structure, testing basis, and a mutual agreement with specified objectives are to be considered in the selection of conditioning level for testing.
SCOPE
1.1 This practice covers conditioning of flexible barrier materials for the determination of flex resistance. Subsequent testing can be performed to determine the effects of flexing on material properties. These tests are beyond the scope of this practice.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only.  
4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.”  
4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be perf...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.  
1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.  
1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.  
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.  
1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.  
1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”  
1.7 The data obtained from accelerated aging studies is no...

SIGNIFICANCE AND USE
3.1 Use of this guide, supplemental to the use of properly designed and maintained equipment and effective management of the production unit process, is expected to minimize costs and product loss. Training of operational personnel is essential. Each of the topics stated in this guide should be addressed in the producers program of training for operators and supervisors to ensure that each individual is aware of them and consciously employs them wherever the need or opportunity exists.
SCOPE
1.1 This guide is recommended for use by all producers of food in retort pouches. Adherence to this guide will help prevent damage to the pouches by preventing and avoiding known causes of damage that occur in the processing environment.  
1.2 This guide for flexible retort food pouches is based on the recommendations of a task force created by the Department of the Army in 1986.2 The purpose of the task force was to determine the possible causes of holes in pouches of food product produced for operational rations for the Department of Defense at that time. Members of the task force visited several food processors to observe and evaluate manufacturing methods commonly being used for processing retort pouches. The recommendations in this guide should be useful as the basis for good manufacturing practices and employee training programs used by food pouch processors.3  
1.3 This standard may involve hazardous materials, operations, and equipment. 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 Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.  
5.2 Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited.
Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.  
5.5 Standards such as ISO 11607-1 and ISO 11607-2 have established criteria for consideration in material testing and for validation. This guide supports the expectations of appropriate materials and package testing occurring within a system of validations supporting demonstration of compliance to ISO 11607-1 and ISO 11607-2.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.  
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.  
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.  
1.4 This guide addresses some critical printing requirements on the pouch.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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 Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.  
5.2 Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible barrier materials.  
1.2 This guide addresses some critical printing requirements for flexible barrier materials.  
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.  
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.  
3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.  
3.3 Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.  
3.4 Additions or deletions to the examples should be reported to Subcommittee F02.50 on Package Design and Development, for incorporation into this classification during the next revision.  
3.5 Additions require F02.50 Task Group review of CFR Title 16 Part 1700 full protocol testing reports. Reports should cover procedures and all CFR Title 16 Part 1700 required reporting elements. Additional information may be requested.  
3.6 Use of a package cited in this classification allows for the statement “CONFORMS TO ASTM D3475,” and does not allow for the use of the ASTM logo or result in an ASTM certification mark.
SCOPE
1.1 This classification covers various types of child-resistant packages.  
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in the understanding and comprehension of each type of classification.  
1.3 Listings are not to be considered endorsements or approval of the package by ASTM.  
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.

ABSTRACT
This specification defines the standard temperature and humidity for conditioning and testing of materials at nominally ambient conditions. Materials for conditioning and testing include material containing paper and plastic material. The instruments and techniques used to measure these standard conditions of temperature and humidity must be validated.
SIGNIFICANCE AND USE
4.1 Conditioning is used to minimize the variation in test results that may result from fluctuations in temperature and humidity, or both. Many flexible packaging materials or components of flexible packaging materials, particularly materials that are hygroscopic, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied.  
4.2 Many packaging materials do not exhibit a meaningful change in physical properties across the temperature and humidity range that is generally found in office and general laboratory settings. As a result, conditioning of samples is often not required in order to achieve useful test results and is often bypassed during routine testing.  
4.3 Conditioning should be considered when (a) comparing between or among laboratory results (for example, supplier and customer), (b) temperature or humidity is anticipated to have an effect on the test outcomes, or (c) potential sources of variation in test results must be minimized.  
4.4 Temperature and humidity alone are not sufficient to completely define a storage condition. Many other factors may be relevant (such as time, light, and atmospheric pressure) that are not defined in this specification.
SCOPE
1.1 This practice defines the standard temperature and humidity for conditioning and testing of flexible barrier packaging and flexible barrier packaging materials at nominally ambient conditions.  
1.2 There are many other temperature and humidity conditions that may be appropriately used to test end use conditions (such as freezer, refrigerated, or abusive storage). These need to be individually established and are not in the scope of this practice.  
1.3 Only those materials that fall under the general area of flexible barrier packaging materials are included in this practice.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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.

SCOPE
1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.  
1.2 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 assists in evaluating the effect of layout, typeface, type size, color, and background on the legibility of printed matter.  
5.2 Previous research3 has shown that results are more significantly impacted by subject age than any other effect. Older subjects tend to require more light when using this instrument. Because subjects age at different rates as a result of lifestyle and genetics, variability of data tends to increase with increasing age. This test method was developed using subjects of ages 19 to 28 years. It is advised that subjects age 19 to 28 be used in cases where variability needs to be kept to a minimum.  
5.3 Testers can compare legibility between various groups of subjects (by age, light intensity, distance, vision characteristics of the subjects) and one against other label configurations within groups of subjects
SCOPE
1.1 This test method provides an objective means to comparatively measure the ease of reading printed matter for use in package labeling.  
1.2 This test method is not intended to quantify the legibility of a printed item against a standard but to compare its legibility against other items.  
1.3 This test method uses human subjects to view printed matter mounted in a specialized instrument.  
1.4 The user of this test method must be aware that results may differ from one age group of subjects to another.  
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.  
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
4.1 Addressing consensus standards with inter-laboratory studies (ILS) and methods specific to an organization. Test methods need to be validated in many cases, in order to be able to rely on the results. This has to be done at the organization performing the tests but is also performed in the development of standards in inter-laboratory studies (ILS), which are not substitutes for the validation work to be performed at the organization performing the test.  
4.1.1 Validations at the Testing Organization—Validations at the test performing organization include planning, executing, and analyzing the studies. Planning should include description of the scope of the test method which includes the description of the test equipment as well as the measurement range of samples it will be used for, rationales for the choice of samples, the amount of samples as well as rationales for the choice of methodology.  
4.1.2 Objective of ILS Studies—ILS studies (per E691-14) are not focused on the development of test methods but rather with gathering the information needed for a test method precision statement after the development stage has been successfully completed. The data obtained in the interlaboratory study may indicate however, that further effort is needed to improve the test method. Precision in this case is defined as the repeatability and reproducibility of a test method, commonly known as gage R&R. For interlaboratory studies, repeatability deals with the variation associated within one appraiser operating a single test system at one facility whereas reproducibility is concerned with variation between labs each with their own unique test system. It is important to understand that if an ILS is conducted in this manner, reproducibility between appraisers and test systems in the same lab are not assessed.  
4.1.3 Overview of the ILS Process—Essentially the ILS process consists of planning, executing, and analyzing studies that are meant to assess the precision of a tes...
SCOPE
1.1 This guide provides information to clarify the process of validating packaging test methods specific for an organization utilizing them as well as through inter-laboratory studies (ILS), addressing consensus standards with inter-laboratory studies (ILS) and methods specific to an organization.  
1.1.1 ILS discussion will focus on writing and interpretation of test method precision statements and on alternative approaches to analyzing and stating the results.  
1.2 This document provides guidance for defining and developing validations for both variable and attribute data applications.  
1.3 This guide provides limited statistical guidance; however, this document does not purport to give concrete sample sizes for all packaging types and test methods. Emphasis is on statistical techniques effectively contained in reference documents already developed by ASTM and other organizations.  
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 This practice is valuable in determining the resistance of flexible packaging materials to flex-formed pinhole failures. Conditioning levels A, B, or C are typically used. Reference Practice E171 and Guide F2097.  
5.2 Conditioning D and E are typically used for determining the effect of flexing on barrier properties transmission rates related to gas and/or moisture.  
5.3 This practice does not measure or condition materials for abrasion related to flex failure.  
5.4 Failures in the integrity of one or more of the plies of a multi-ply structure may require alternative testing. Supplementary permeation testing using gas or water vapor can be used in conjunction with the flex test to measure the loss of ply integrity. Other test methods may be used after flexing for assessment of presence of pinholes. For a list of test methods, refer to Guide F2097.
FIG. 1 Planar Evolution of Gelbo Shaft Helical Groove 30.70-mm [1.20-in.] Diameter Shaft  
5.4.1 The various conditions described in this practice are to prevent evaluating a material structure with an outcome of too many holes to effectively count (normally greater than 50), or too few to be significant (normally less than five per sample). Material structure, testing basis, and a mutual agreement with specified objectives are to be considered in the selection of conditioning level for testing.
SCOPE
1.1 This practice covers conditioning of flexible barrier materials for the determination of flex resistance. Subsequent testing can be performed to determine the effects of flexing on material properties. These tests are beyond the scope of this practice.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.  
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.

SCOPE
1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.  
1.2 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.

SCOPE
1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.  
1.2 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 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.  
3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.  
3.3 Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.  
3.4 Additions or deletions to the examples should be reported to Subcommittee F02.50 on Package Design and Development, for incorporation into this classification during the next revision.  
3.5 Additions require F02.50 Task Group review of CFR Title 16 Part 1700 full protocol testing reports. Reports should cover procedures and all CFR Title 16 Part 1700 required reporting elements. Additional information may be requested.  
3.6 Use of a package cited in this classification allows for the statement “CONFORMS TO ASTM D3475,” and does not allow for the use of the ASTM logo or result in an ASTM certification mark.
SCOPE
1.1 This classification covers various types of child-resistant packages.  
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in the understanding and comprehension of each type of classification.  
1.3 Listings are not to be considered endorsements or approval of the package by ASTM.  
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.

SCOPE
1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.  
1.2 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 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.  
3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.  
3.3 Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.  
3.4 Additions or deletions to the examples should be reported to Committee D10 on Packaging, for incorporation into this classification during the next revision.
SCOPE
1.1 This classification covers various types of child-resistant packages.  
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in the understanding and comprehension of each type of classification.  
1.3 Listings are not to be considered endorsements or approval of the package by ASTM.  
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
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.  
4.2 ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.”  
4.3 Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.  
4.4 Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.  
4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or ...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.  
1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.  
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.  
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.  
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.  
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of “environmental challenging.”  
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.

SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.or alteration.  
This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems. This practice does not cover refrigerated, frozen food storage, or cryogenic storage conditions. Only the climatic environments encountered in various regions o...
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.

SIGNIFICANCE AND USE
3.1 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.  
3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.  
3.3 Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.  
3.4 Additions or deletions to the examples should be reported to Committee D10 on Packaging, for incorporation into this classification during the next revision.
SCOPE
1.1 This classification covers various types of child-resistant packages.  
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in the understanding and comprehension of each type of classification.  
1.3 Listings are not to be considered endorsements or approval of the package by ASTM.

SIGNIFICANCE AND USE
5.1 This practice is valuable in determining the resistance of flexible-packaging materials to flex-formed pinhole failures. Conditioning levels A, B, or C are typically used for this evaluation.  
5.2 This practice is valuable for determining the effect of flexing on barrier properties such as gas and/or moisture transmission rates. Conditioning levels D or E are typically used for this evaluation.  
5.3 This practice does not measure any abrasion component relating to flex failure.  
5.4 Failures in the integrity of one or more of the plies of a multi-ply structure may require different testing than the detection of holes completely through the structure. Permeation tests using gas or water vapor can be used in conjunction with the flex test to measure the loss of ply integrity. However, any permeation test requiring a pressure differential will not measure the permeation coefficient in the presence of pinholes. For a list of test methods refer to Guide F2097.  
5.4.1 The various conditions described in this procedure are to prevent testing a structure under conditions that either give too many holes to effectively count (normally greater than 50), or too few to be significant (normally less than five per sample). Material structure, purpose for testing and a mutual agreement between parties involved are important points to consider in the selection of conditioning level for testing.
SCOPE
1.1 This practice covers conditioning of flexible barrier materials for the determination of flex resistance. Subsequent testing can be performed to determine the effects of flexing on material properties. These tests are beyond the scope of this practice.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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 Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.  
5.2 Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible barrier materials.  
1.2 This guide addresses some critical printing requirements for flexible barrier materials.  
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.  
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced.  
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.

ABSTRACT
This specification defines the standard temperature and humidity for conditioning and testing of materials at nominally ambient conditions. Materials for conditioning and testing include material containing paper and plastic material. The instruments and techniques used to measure these standard conditions of temperature and humidity must be validated.
SIGNIFICANCE AND USE
4.1 Conditioning is used to minimize the variation in test results that may result from fluctuations in temperature and humidity, or both. Many flexible packaging materials or components of flexible packaging materials, particularly materials that are hygroscopic, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied.  
4.2 Many packaging materials do not exhibit a meaningful change in physical properties across the temperature and humidity range that is generally found in office and general laboratory settings. As a result, conditioning of samples is often not required in order to achieve useful test results and is often bypassed during routine testing.  
4.3 Conditioning should be considered when (a) comparing between or among laboratory results (for example, supplier and customer), (b) temperature or humidity is anticipated to have an effect on the test outcomes, or (c) potential sources of variation in test results must be minimized.  
4.4 Temperature and humidity alone are not sufficient to completely define a storage condition. Many other factors may be relevant (such as time, light, and atmospheric pressure) that are not defined in this specification.
SCOPE
1.1 This specification defines the standard temperature and humidity for conditioning and testing of flexible barrier packaging and flexible barrier packaging materials at nominally ambient conditions.  
1.2 There are many other temperature and humidity conditions that may be appropriately used to test end use conditions (such as freezer, refrigerated, or abusive storage). These need to be individually established and are not in the scope of this practice.  
1.3 Only those materials that fall under the general area of flexible barrier packaging materials are included in this practice.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

SIGNIFICANCE AND USE
3.1 Use of this guide, supplemental to the use of properly designed and maintained equipment and effective management of the production unit process, is expected to minimize costs and product loss. Training of operational personnel is essential. Each of the topics stated in this guide should be addressed in the producers program of training for operators and supervisors to ensure that each individual is aware of them and consciously employs them wherever the need or opportunity exists.
SCOPE
1.1 This guide is recommended for use by all producers of food in retort pouches. Adherence to this guide will help prevent damage to the pouches by preventing and avoiding known causes of damage that occur in the processing environment.  
1.2 This guide for flexible retort food pouches is based on the recommendations of a task force created by the Department of the Army in 1986.2 The purpose of the task force was to determine the possible causes of holes in pouches of food product produced for operational rations for the Department of Defense at that time. Members of the task force visited several food processors to observe and evaluate manufacturing methods commonly being used for processing retort pouches. The recommendations in this guide should be useful as the basis for good manufacturing practices and employee training programs used by food pouch processors.3  
1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns 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 Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.  
5.2 Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited.
Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.  
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.  
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.  
1.4 This guide addresses some critical printing requirements on the pouch.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.Note 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.  
4.6 Test Description and Applicability (see Table 1):  
4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
4.6.1.1 Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized...
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.

SCOPE
1.1 This terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SCOPE
1.1 This terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SCOPE
1.1 This terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SIGNIFICANCE AND USE
Conditioning is used to minimize the variation in test results that may result from fluctuations in temperature and humidity, or both. Many flexible packaging materials or components of flexible packaging materials, particularly materials that are hygroscopic, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied.
Many packaging materials do not exhibit a meaningful change in physical properties across the temperature and humidity range that is generally found in office and general laboratory settings. As a result, conditioning of samples is often not required in order to achieve useful test results and is often bypassed during routine testing.
Conditioning should be considered when (a) comparing between or among laboratory results (for example, supplier and customer), (b) temperature or humidity is anticipated to have an effect on the test outcomes, or (c) potential sources of variation in test results must be minimized.
Temperature and humidity alone are not sufficient to completely define a storage condition. Many other factors may be relevant (such as time, light, and atmospheric pressure) that are not defined in this specification.
SCOPE
1.1 This specification defines the standard temperature and humidity for conditioning and testing of flexible barrier packaging and flexible barrier packaging materials at nominally ambient conditions.
1.2 There are many other temperature and humidity conditions that may be appropriately used to test end use conditions (such as freezer, refrigerated, or abusive storage). These need to be individually established and are not in the scope of this practice.
1.3 Only those materials that fall under the general area of flexible barrier packaging materials are included in this practice.
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. ^REFERENCE:
ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
F17 Terminology Relating to Flexible Barrier Packaging
F2825 Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery

SIGNIFICANCE AND USE
Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.
Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.
The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible barrier materials.
1.2 This guide addresses some critical printing requirements for flexible barrier materials.
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced.
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 loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.”
Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or shelf life is based on t...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.
1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of “environmental challenging.”
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.

SIGNIFICANCE AND USE
This test method assists in evaluating the effect of layout, typeface, type size, color, and background on the legibility of printed matter.
Previous research has shown that results are more significantly impacted by subject age than any other effect. Older subjects tend to require more light when using this instrument. Because subjects age at different rates as a result of lifestyle and genetics, variability of data tends to increase with increasing age. This test method was developed using subjects of ages 19 to 28 years. It is advised that subjects age 19 to 28 be used in cases where variability needs to be kept to a minimum.
Testers can compare legibility between various groups of subjects (by age, light intensity, distance, vision characteristics of the subjects) and one against other label configurations within groups of subjects
SCOPE
1.1 This test method provides an objective means to comparatively measure the ease of reading printed matter for use in package labeling.
1.2 This test method is not intended to quantify the legibility of a printed item against a standard but to compare its legibility against other items.  
1.3 This test method uses human subjects to view printed matter mounted in a specialized instrument.
1.4 The user of this test method must be aware that results may differ from one age group of subjects to another.  
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 practice is valuable in determining the resistance of flexible-packaging materials to flex-formed pinhole failures. Conditioning levels A, B, or C are typically used for this evaluation.
This practice is valuable for determining the effect of flexing on barrier properties such as gas and/or moisture transmission rates. Conditioning levels D or E are typically used for this evaluation.
This practice does not measure any abrasion component relating to flex failure.
Failures in the integrity of one or more of the plies of a multi-ply structure may require different testing than the detection of holes completely through the structure. Permeation tests using gas or water vapor can be used in conjunction with the flex test to measure the loss of ply integrity. However, any permeation test requiring a pressure differential will not measure the permeation coefficient in the presence of pinholes. For a list of test methods refer to Guide F2097.
The various conditions described in this procedure are to prevent testing a structure under conditions that either give too many holes to effectively count (normally greater than 50), or too few to be significant (normally less than five per sample). Material structure, purpose for testing and a mutual agreement between parties involved are important points to consider in the selection of conditioning level for testing.
SCOPE
1.1 This practice covers conditioning of flexible barrier materials for the determination of flex resistance. Subsequent testing can be performed to determine the effects of flexing on material properties. These tests are beyond the scope of this practice.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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 specification covers the size, color and pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. The size and background color requirements of drug labels are presented in details. The type and color requirements of printing for drug labels are presented in details.
SIGNIFICANCE AND USE
The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use.
The user may alternatively use black and white labels rather than these colored labels.
SCOPE
1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.
1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the 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.
FIG. 1 Standard Background Colors for User Applied Syringe Drug Labels
FIG. 2 Label for an Antagonist Drug
FIG. 3 Reversed Plate Printing Used to Identify
"SUCCINYLcholine," "EPINEPHrine," and Beta Blockers,
"ESMOlol," "LABATolol," and "METOprolol"
NoteBold upper-case type is shown for first or first and second syllables of the drug name.FIG. 4 Optional Printing
FIG. 5 Drug Name and Dosage
FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL

SIGNIFICANCE AND USE
This practice provides a method for conditioning packaging systems using climatic conditions that occur in actual distribution. The recommended exposure levels are based on available information on shipping, handling and storage environments, current industry practices, and published studies. They are not absolute extremes, but recorded daily averages in cold and hot climates of the world.
SCOPE
1.1 This practice provides a uniform basis for evaluating, in a laboratory, the ability of a packaging system to withstand a range of climatic stresses that a packaging system may be exposed to during distribution throughout the world and still provide the product protection from damage or alteration.
1.2 This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems.
1.3 This practice does not cover refrigerated, frozen food storage, or cryogenic storage conditions. Only the climatic environments encountered in various regions of the world are covered by this practice.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.

SIGNIFICANCE AND USE
This practice provides a method for conditioning packaging systems using climatic conditions that occur in actual distribution. The recommended exposure levels are based on available information on shipping, handling and storage environments, current industry practices, and published studies. They are not absolute extremes, but recorded daily averages in cold and hot climates of the world.
SCOPE
1.1 This practice provides a uniform basis for evaluating, in a laboratory, the ability of a packaging system to withstand a range of climatic stresses that a packaging system may be exposed to during distribution throughout the world and still provide the product protection from damage or alteration.
1.2 This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems.
1.3 This practice does not cover refrigerated, frozen food storage, or cryogenic storage conditions. Only the climatic environments encountered in various regions of the world are covered by this practice.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.

SIGNIFICANCE AND USE
Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.
Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable.  
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.
1.4 This guide addresses some critical printing requirements on the pouch.
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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 design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.
The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.
Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
All categories must be considered for applicability.
The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
Test Description and Applicability (see Table 1):
Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data ...
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.

SCOPE
1.1 This terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SIGNIFICANCE AND USE
This design and evaluation guide describes seven categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, and printing ink properties.
The intent of this design and evaluation guide is to evaluate all seven categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
All seven categories must be considered for applicability.
The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
Test Description and Applicability (see Table 1):
Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility.
Package Compliance: Routine Monitoring of Adherence to Specifications—This is referred to as “Compliance Testing” in Table 1. Testi...
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

SIGNIFICANCE AND USE
Use of this guide, supplemental to the use of properly designed and maintained equipment and effective management of the production unit process, is expected to minimize costs and product loss. Training of operational personnel is essential. Each of the topics stated in this guide should be addressed in the producers program of training for operators and supervisors to ensure that each individual is aware of them and consciously employs them wherever the need or opportunity exists.
SCOPE
1.1 This guide is recommended for use by all producers of food in retort pouches. Adherence to this guide will help prevent damage to the pouches by preventing and avoiding known causes of damage that occur in the processing environment.
1.2 This guide for flexible retort food pouches is based on the recommendations of a task force created by the Department of the Army in 1986. The purpose of the task force was to determine the possible causes of holes in pouches of food product produced for operational rations for the Department of Defense at that time. Members of the task force visited several food processors to observe and evaluate manufacturing methods commonly being used for processing retort pouches. The recommendations in this guide should be useful as the basis for good manufacturing practices and employee training programs used by food pouch processors.  
1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns 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 terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SIGNIFICANCE AND USE
Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.
Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F 2097.
The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible barrier materials.
1.2 This guide addresses some critical printing requirements for flexible barrier materials.
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F 2559 should be referenced.
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 terminology covers the principal terms relating to flexible barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.

SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

SCOPE
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006 and the physical properties of their component packaging materials.
1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D 4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F 1327 for a definition of "environmental challenging."
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.

ABSTRACT
This specification defines the standard temperature and humidity for conditioning and testing of materials at nominally ambient conditions. Materials for conditioning and testing include material containing paper and plastic material. The instruments and techniques used to measure these standard conditions of temperature and humidity must be validated.
SCOPE
1.1 This specification defines the standard temperature and humidity for conditioning and testing of materials at nominally ambient conditions.
1.2 There are many other temperature and humidity conditions which may be appropriately used to test end use conditions such as freezer, refrigerated or abusive storage. These need to be individually established.
1.3 Temperature and humidity alone are not sufficient to completely define a storage condition. Many other factors may be relevant (such as time, light and atmospheric pressure) which are not defined in this specification.
1.4 Only those materials which fall into the general area of flexible packaging materials are included. Many other materials which were included in earlier versions of this specification may also need a definition.