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    ASTM F1984-99(2008)

    Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
    • 발행일 : 2008-08-01
    • 발행기관 : ASTM
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분야 13.01 : 의료기, 외과용 도구 및 장비
적용범위

1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.

1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of solid materials intended for use in contact with blood. For this practice, the words serum and complement are used interchangeably (most biological supply houses use these words synonymously in reference to serum used as a source of complement).

1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum, using a 0.1-mL serum/13 x 100-mm disposable test tube. Cellulose acetate powders and fibers are used as examples of test materials. Procedure B describes assaying the exposed serum for significant functional whole complement depletion as compared to control samples.

1.4 This practice does not address function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement.

1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility.

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

국제분류(ICS)코드
페이지수 5
Edition 99(2008)

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F1984-25상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2025-02-15 표준
2 ASTM F1984-25 REDLINE상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2025-02-15 표준
3 ASTM F1984-99(2018)상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2018-02-01 구판
4 ASTM F1984-99(2013)상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2013-12-01 구판
5 ASTM F1984-99(2008)상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2008-08-01 구판
6 ASTM F1984-99(2003)상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 2003-11-01 구판
7 ASTM F1984-99상세보기 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials 1999-06-10 구판

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