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Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) (Includes all amendments And changes 12/31/2010).
Automatically translated name:
Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
STANDARD published on 1.5.2004
Designation standards: ASTM F2382-04e1
Note: WITHDRAWN
Publication date standards: 1.5.2004
SKU: NS-53726
The number of pages: 3
Approximate weight : 9 g (0.02 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
blood coagulation, blood compatibility, partial thromboplastin time, PTT, ICS Number Code 11.100 (Laboratory medicine)
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. |
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2. Referenced Documents | ||||
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