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ASTM F719-81(2012)

(Practice)

Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and inexpensive method which, through use over the years, has become a generally accepted method.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
30-Sep-2012
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F719-81(2007)e1 - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Effective Date
01-Oct-2012
Referred By
ASTM F2808-23 - Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
Effective Date
01-Oct-2012
Referred By
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Oct-2012
Referred By
ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Effective Date
01-Oct-2012

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ASTM F719-81(2012) - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin IrritationASTM F719-81(2012) - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
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ASTM F719-81(2012) - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F719 − 81 (Reapproved 2012)
Standard Practice for
Testing Biomaterials in Rabbits for Primary Skin Irritation
ThisstandardisissuedunderthefixeddesignationF719;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Significance and Use
1.1 This practice covers a procedure by which the irritancy 4.1 Materials that are to be in contact with the skin should
of a biomaterial may be assessed through contact with abraded not cause irritation to the skin. Since it is probably the
and intact skin of rabbits. substancesleachedfromamaterialthatcausetheirritation,this
practice provides for direct material-skin contact testing or for
1.2 The results of this practice depend upon the effective-
skin exposure to the liquid extract of the test material. The
ness with which contact between the skin and the test material
rationale for this rabbit test is that it is a comparatively quick
is established and maintained. Because of the operator tech-
and inexpensive method which, through use over the years, has
nique included in performing this test, it is important that the
become a generally accepted method.
test be performed by personnel with appropriate training.
1.3 The values stated in SI units are to be regarded as
5. Materials and Manufacture
standard. No other units of measurement are included in this
5.1 Young New Zealand Albino Rabbits,
standard.
5.2 Gauze Flats, 2.5 by 2.5-cm,
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 5.3 Polyethylene Sleeves, extra clear, and
responsibility of the user of this standard to establish appro-
5.4 Adhesive Tape, ⁄2-in.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
6. Test Specimen
6.1 The test specimen may be one of three forms:
2. Referenced Documents
6.1.1 Test 0.5 mL of liquids or saline extract liquids ob-
2.1 ASTM Standards:
tained in accordance with Practice F619.
F619 Practice for Extraction of Medical Plastics
6.1.2 Test 0.5 g of solids or semisolids.
6.1.3 Test films 2.5 by 2.5 cm.
3. Summary of Practice
NOTE 1—A vehicle control for liquids is required because of the
3.1 Exposure of skin to the test material is accomplished by
potential for false positives due to skin temperature changes when
means of a patch test technique employing two intact and two
handlingrabbits.Positivecontrolsmaybeusedtovalidatethetestmethod.
abraded sites on the back of each of six albino rabbits.The skin 3
The use of 5 % procaine HCl as a positive control is suggested.
is clipped free of hair one day prior to testing. The test
6.2 The pH of the solutions should be measured and
substance is applied using 0.5 mL for liquids, 0.5 g for solids
reported, if appropriate.
or semisolids, and a 2.5 by 2.5-cm square patch for films.After
application,eachtestsiteiscoveredwitha2.5by2.5-cmgauze
7. Procedure
flat,andtheentiretrunkisoccludedwithapolyethylenesleeve.
7.1 Preparation of Test Animals:
After 24 h, the sleeve, flat, and test material are removed, and
7.1.1 Twenty-four hours before the test, clip the hair from
test sites are evaluated for erythema and edema.
the backs of the animals so as to expose two test areas on each
side of the spine, which are 10 cm apart.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
7.1.2 To obtain more effective contact between the skin and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
the test substance, it may be necessary to use a non-irritating
F04.16 on Biocompatibility Test Methods.
depilatory agent. This test method may be used to ensure that
Current edition approved Oct. 1, 2012. Published October 2012. Originally
ε1
approved in 1981. Last previous edition approved in 2007 as F719 – 81 (2007) .
the depilatory agent is non-irritating.
DOI: 10.1520/F0719-81R12.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on H. H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs, and
the ASTM website. Cosmetics, 1965, p. 46.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F719 − 81 (2012)
TABLE 1 Scoring Criteria for Test Reactions
7.1.3 Testsitesmaybedesignatedastwooneachsideofthe
spine. Alternat
...

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5.1 This test method is intended to assess a combination of inherent chemical irritation and mechanical irritation for products and materials expected to come into contact with the skin. It is a comparative approach whereby the potential irritation of a test material is compared to that of a reference material similar in form and composition. The reference material should have a known safety and irritation profile.
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1.1 The behind-the-knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references (1-7)).2 This is a bilateral test comparing a test material to a reference material with a known safety profile.  
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1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated.  
1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale.  
1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted.  
1.6 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.  
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SCOPE
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4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.  
4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.  
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.  
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FDA CFR:  
21 CFR 3: Product Jurisdiction:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3    
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
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21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.  
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...

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ASTM
ASTM F619-20(Practice)
Standard Practice for Extraction of Materials Used in Medical Devices

SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.  
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).  
5.4 Caution should be exercised in the understanding and intent of this practice as follows:  
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.  
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
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1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.  
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.  
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
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.  
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 thi...

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ASTM
ASTM F719-20e1(Practice)
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
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1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard 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.  
1.5 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.

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