한국표준정보망

회원가입 로그인 비회원(주문조회) 장바구니 이용안내

English
검색 마이페이지 장바구니0

QUICK

닫기

TOP

해외표준 상세정보

관심표준 등록 : 표준업데이트 시 알림서비스

제공형태 더보기

  • KS

    구판

    판매

    ASTM F2808-17

    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
    • 발행일 : 2017-11-01
    • 발행기관 : ASTM
    즐겨찾기 장바구니 담기
    닫기

    상품이 장바구니에 담겼습니다.

    장바구니로 이동

    • [영어]PDF 191,700원

    • [영어]PRINT 191,700원

상세정보

분야 13.02 : 긴급 의료 서비스; 수색 및 구조
적용범위

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 pre-defined 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 health 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.
국제분류(ICS)코드 11.100.99 : 약실험과 관련한 다른 표준
페이지수 23
Edition 17

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F2808-23상세보기 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 2023-04-01 표준
2 ASTM F2808-23 REDLINE상세보기 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 2023-04-01 표준
3 ASTM F2808-17 REDLINE상세보기 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 2017-11-01 구판
4 ASTM F2808-17상세보기 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 2017-11-01 구판
5 ASTM F2808-10상세보기 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 2010-10-15 구판

관련상품

  • 관련상품이 존재하지 않습니다.

다른 사람이 함께 구입한 상품

  • 함께 구입한 상품이 존재하지 않습니다.

추천 상품

제공형태 닫기

  • PDF :

    직접 파일 다운로드 및 인쇄(마이페이지 확인)

  • 보안PDF :

    직접 파일 다운로드 및 인쇄(마이페이지 확인)* 단, 파일이동 및 복사 불가, 1회 다운로드 및 인쇄가능

  • PRINT :

    인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)

  • BOOK :

    인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)

  • ZIP :

    압축파일형태로 제공 (PDF, HTML, TXT, XLS 등으로 구성), 직접 파일 다운로드(마이페이지 확인)

  • CD/DVD :

    직접 파일 다운로드 및 인쇄(마이페이지 확인)

  • DB :

    별도 정보 제공

  • HARDCOPY :

    해외 배송 상품, 최대 3주 소요

  • 바인더 :

    바인더 우편발송, 2~3일 소요

  • 온라인구독 :

    WEB 접속 후 실시간 열람, 출력(1년간)