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ASTM F719-20e1

(Practice)

Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

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.
SCOPE
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.

General Information

Status
Published
Publication Date
31-Mar-2020
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

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ASTM F719-20e1 - Standard Practice for Testing Materials in Rabbits for Primary Skin IrritationASTM F719-20e1 - Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
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ASTM F719-20e1 - Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
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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.
´1
Designation: F719 − 20
Standard Practice for
1
Testing Materials 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
ε NOTE—Editorial correction was made to 8.1 in November 2020.
1. Scope 3. Summary of Practice
3.1 Exposure of skin to the test material is accomplished by
1.1 This practice covers a procedure by which the irritancy
means of a patch test technique employing two intact and two
ofamaterialmaybeassessedthroughcontactwithabradedand
abradedsitesonthebackofeachofthreealbinorabbitspertest
intact skin of rabbits.
article. The skin is clipped free of hair one day prior to testing.
1.2 The results of this practice depend upon the effective-
The test substance is applied using 0.5 mLfor liquids, 0.5 g for
ness with which contact between the skin and the test material
solidsorsemisolids,anda2.5by2.5-cmsquarepatchforfilms.
is established and maintained. Because of the operator tech-
After application, each test site is covered with a 2.5 by 2.5-cm
nique included in performing this test, it is important that the
gauze flat, and the entire trunk is occluded with a polyethylene
test be performed by personnel with appropriate training.
sleeve. After 24 h, the sleeve, flat, and test material are
1.3 The values stated in SI units are to be regarded as
removed, and test sites are evaluated for erythema and edema.
standard. No other units of measurement are included in this
4. Significance and Use
standard.
4.1 Materials that are to be in contact with the skin should
1.4 This standard may involve hazardous materials,
not cause irritation to the skin. Since it is probably the
operations, and equipment. This standard does not purport to
substancesleachedfromamaterialthatcausetheirritation,this
address all of the safety concerns, if any, associated with its
practice provides for direct material-skin contact testing or for
use. It is the responsibility of the user of this standard to
skin exposure to the liquid extract of the test material. The
establish appropriate safety, health, and environmental prac-
rationale for this rabbit test is that it is a comparatively quick
tices and determine the applicability of regulatory limitations
and sensitive method which, through use over the years, has
prior to use.
become a generally accepted method. Additionally, the albino
1.5 This international standard was developed in accor-
rabbit allows for easy visualization of erythema and edema,
dance with internationally recognized principles on standard-
which are the cardinal signs of skin irritation.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
5. Materials and Manufacture
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. 5.1 Young New Zealand Albino Rabbits, Healthy young
adult albino rabbits of either sex, weighing not less than 2 kg,
2. Referenced Documents shall be used. Animal care shall be in accordance with the
3
2 “Guide for Care and Use of Laboratory Animals”;
2.1 ASTM Standards:
5.2 Gauze Flats, 2.5 by 2.5-cm;
F619 Practice for Extraction of Materials Used in Medical
Devices
5.3 Polyethylene Sleeves, extra clear;
1
5.4 Adhesive Tape, ⁄2-in. width.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
6. Test Specimen
Surgical Materials and Devices and is the direct responsibility of Subcommittee
6.1 The test specimen may be one of three forms:
F04.16 on Biocompatibility Test Methods.
Current edition approved April 1, 2020. Published June 2020. Originally
6.1.1 Test 0.5 mL of liquids, saline, or vegetable oil extract
approved in 1981. Last previous edition approved in 2012 as F719 – 81 (2012).
liquids obtained in accordance with Practice F619.
DOI: 10.1520/F0719-20E01.
2
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
3
Standards volume information, refer to the standard’s Document Summary page on National Research Council, “Guide for the Care and Use of Laboratory
the ASTM website. Animals,” Washington, DC, National Academy Press, 2011.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
F719 − 20
TABLE 1 Scoring Criteria for Test Reaction
...

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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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1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale.  
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4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.  
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SCOPE
1.1 This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.  
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4.1 This guide covers animal implantation methods and analysis of the explanted DBM-containing material to determine whether a material or substance possesses osteoinductive potential, as defined by its ability to cause bone to form in vivo at a site that would otherwise not support bone formation, that is, heterotopically in a skeletal muscle implant site. For in vitro evaluation see Test Method F2131 for in vitro assessment of rhBMP 2.  
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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/
CFRSearch.cfm?CFRPart=58    
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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 F3352/F3352M-23b(Specification)
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

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1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.  
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.  
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
1.4 Units—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 nonconformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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