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AS ISO 10993.1-2002

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

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Withdrawn date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

01-01-2002

Preview

Describes the principles governing biological evaluation and testing of medical devices.

This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests.This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword. (See also the rationale in A.2.)

Committee
HE-012
DocumentType
Standard
ISBN
0 7337 4696 9
Pages
12
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-1:1997 Identical

First published as AS ISO 10993.1-2002.

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