• Shopping Cart
    There are no items in your cart

ASTM F 2808 : 2023

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-04-2023

€80.76
Excluding VAT

Committee
F 04
DocumentType
Test Method
Pages
24
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1The 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.

1.2This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.

1.3This 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.

1.4Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale.

1.5Prior 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.

1.6The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.

1.7This 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.

1.8This 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.

ASTM F 3540 : 2021 Standard Guide for Hazards for Consideration when Designing Exoskeletons

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.