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BS EN ISO 10993-1:June 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Biological evaluation of medical devices Evaluation and testing

Available format(s)

Hardcopy , PDF

Superseded date

31-01-2017

Language(s)

English

Published date

30-04-2010

€243.07
Excluding VAT

Committee
CH/194
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

This part of ISO 10993 describes the general principles governing the biological evaluation of medical devices; the categorization of devices based on the nature and duration of their contact with the body; 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. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).

Standards Relationship
EN ISO 10993-1:2009 Identical
ISO 10993-1:2003 Identical

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