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ASTM F 1984 : 1999 : R2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

11-01-2003

CONTAINED IN VOL. 13.01, 2018 Outlines a protocol for rapid, in vitro screening for whole complement (serum) activating properties of solid materials used in the manufacture of medical devices that will contact blood.

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.

Committee
F 04
DocumentType
Standard Practice
Pages
5
ProductNote
Reconfirmed 2003
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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