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

SIGNIFICANCE AND USE
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.
SCOPE
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.  
1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.  
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.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Mar-2023
• 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

Standards Content (Sample)

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.
Designation: F2808 − 23
Standard Test Method for
Performing Behind-the-Knee (BTK) Test for Evaluating Skin
Irritation Response to Products and Materials That Come
1
Into Repeated or Extended Contact with Skin
This standard is issued under the fixed designation F2808; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 The behind-the-knee (BTK) method, using the popliteal
responsibility of the user of this standard to establish appro-
fossa of human volunteers as a test site, simultaneously
priate safety, health, and environmental practices and deter-
evaluates the inherent chemical irritation and the potential for
mine the applicability of regulatory limitations prior to use.
mechanical irritation of substrates and products that are de-
1.8 This international standard was developed in accor-
signed to come into repeated or extended close contact with the
2 dance with internationally recognized principles on standard-
skin (see validation references (1-7)). This is a bilateral test
ization established in the Decision on Principles for the
comparing a test material to a reference material with a known
Development of International Standards, Guides and Recom-
safety profile.
mendations issued by the World Trade Organization Technical
1.2 This test method shall be used by qualified health care
Barriers to Trade (TBT) Committee.
professionals experienced in good clinical practice (GCP)
procedures. 2. Referenced Documents
3
1.3 This test method can be performed using human sub- 2.1 ASTM Standards:
jects on either intact or compromised skin. Testing should be D6355 Test Method for Human Repeat Insult Patch Testing
performed on intact skin for test substrates or products ex- of Medical Gloves
pected to have contact with normal, intact skin, or for direct F719 Practice for Testing Materials in Rabbits for Primary
comparison to products with a known skin irritation profile. Skin Irritation
Testing can be performed on compromised skin for test F748 Practice for Selecting Generic Biological Test Methods
substrates or products that may commonly come into contact
for Materials and Devices
4
with damaged skin (for example, skin with diaper rash, or
2.2 ISO Standards:
chapped skin) or skin that is expected to be hydrated.
ISO 10993-1:2009 Biological Evaluation of Medical
Devices—Part 1: Evaluation and Testing Within a Risk
1.4 Visual scoring of erythema and dryness is performed by
Management Process
a trained skin grader on a predefined scale.
ISO 10993-10 Biological Evaluation of Medical Devices—
1.5 Prior to use in this test, materials shall undergo overall
Part 10: Tests for Irritation and Delayed-type Hypersensi-
favorable biocompatibility testing consistent with the approach
tivity
outlined in protocol Practice F748 or ISO 10993-1:2009. As a
part of this series of testing, irritation per Practice F719 or ISO
3. Terminology
10993-10 shall be conducted.
3.1 Definitions:
1.6 The values stated in inch-pound units are to be regarded
3.1.1 chemical irritation, n—irritation caused by a physi-
as standard. No other units of measurement are included in this
ological response to the chemical nature of a material. Such
standard.
physiological responses may include: oxidation or reduction
reactions, dehydration, disruption of the keratin ultra-structure,
or direct injury to cellular macromolecules or organelles.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
3
F04.16 on Biocompatibility Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 1, 2023. Published April 2023. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2010. Last previous edition approved in 2017 as F2808 – 17. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2808-23. the ASTM website.
2 4
The boldface numbers in parentheses refer to the list of references at the end of Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
this standard. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. Unite
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2808 − 17 F2808 − 23
Standard Test Method for
Performing Behind-the-Knee (BTK) Test for Evaluating Skin
Irritation Response to Products and Materials That Come
1
Into Repeated or Extended Contact with Skin
This standard is issued under the fixed designation F2808; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 The Behind-the-Kneebehind-the-knee (BTK) method, using the popliteal fossa of human volunteers as a test site,
simultaneously evaluates the inherent chemical irritation,irritation and the potential for mechanical irritation of substrates and
2
products that are designed to come into repeated or extended close contact with the skin (see validation references (1-7)). This
is a bilateral test comparing a test material to a reference material with a known safety profile.
1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.
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 pre-definedpredefined 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.
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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved Nov. 1, 2017April 1, 2023. Published November 2017April 2023. Originally approved in 2010. Last previous edition approved in 20102017 as
F2808F2808 – 17.-10. DOI: 10.1520/F2808-17.10.1520/F2808-23.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2808 − 23
2. Referenced Documents
3
2.1 ASTM Standards:
D6355 Test Method for Human Repeat Insult Patch Testing of Medical Gloves
F719 Practice for Testing Materials in Rabbits for Primary Skin Irritation
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
4
2.2 ISO Standards:
ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management
Process
ISO 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity
3. Terminology
3.1 Definitions:
3.1.1 chemical irritation, n—irritation caused by a physiological response to the chemical nature of a material. Such physiological
responses may include: oxidation or reduction reactions, dehydration, disruption of the keratin ultra-structureultra-structure, or
direct injury to cellular macromolecules or organelles.
3.1.2 compromised skin, n—skin that is treated with repeated a
...