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ASTM F 2382 : 2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

05-01-2004

1.1 This test method covers the screening of cardiovascular device materials for their ability to induce blood coagulation. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood.

1.2 All safety policies and practices shall be observed during the performance of this test method.

1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labeled with the contents, and disposed by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.

1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using universal precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.

1.5 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.

Committee
F 04
DocumentType
Test Method
Pages
3
ProductNote
Reconfirmed 2004
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Superseded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
ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
ASTM F 2888 : 2019 Standard Practice for Platelet Leukocyte Count—An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials

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US$66.00
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