ASTM F2382 - 18 - Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

ASTM F2382 - 18

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

Status : Current   Published : October 2018

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1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.

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 labelled with the contents, and disposed of 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 standard 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6  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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7  This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.




Standard NumberASTM F2382 - 18
TitleStandard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
StatusCurrent
Publication Date01 October 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors blood coagulation, blood compatibility, partial thromboplastin time, PTT
ICS11.100
11.100.30
PublisherASTM
FormatA4
DeliveryYes
Pages4
File Size69 KB
Price£36.00


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