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AS ISO 10993.4-2003

AS ISO 10993.4-2003

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices - Selection of tests for interactions with blood

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

06-30-2017

Language(s)

English

Published date

01-01-2003

Publisher

Standards Australia

Preview

Specifies general requirements for evaluating the interactions of medical devices with blood. This Standard describes a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

1 ScopeThis part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,b) the fundamental principles governing the evaluation of the interaction of devices with blood,c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Committee
HE-012
DocumentType
Standard
ISBN
0 7337 5368 X
Pages
34
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-4:2002 Identical

First published as AS ISO 10993.4-2002.Second edition 2003. First published as AS ISO 10993.4-2002. Second edition 2003.

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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