ASTM F2382-04e1
Historical Standard: ASTM F2382-04e1 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
SUPERSEDED (see Active link, below)
ASTM F2382
1. Scope
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ANSI Standard
ANSI/AAMI/ISO10993-4 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.Other Document
CentersforDiseaseCon 1999 Available from National Institute of Health (NIH), 9000 Rockville Pike, Bethesda, MD 20892.Keywords
blood coagulation; blood compatibility; partial thromboplastin time; PTT; Medical devices/equipment; Partial Thromboplastin Time (PTT); Blood coagulation; Blood compatibility;
ICS Code
ICS Number Code 11.100 (Laboratory medicine)
DOI: 10.1520/F2382-04E01
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