Standard

ISO 10993-1:2003

Jul 2003 Withdrawn

Note: Now under development: ISO/DIS 10993-1

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Abstract

ISO 10993-1:2003 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. It 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.

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Standard from ISO
Published: July 28 2003
Withdrawn: October 13 2009
Edition: 3
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Adopted by: SN EN ISO 10993-1:2009
Revised by: ISO 10993-1:2009
Adopted by: NF EN ISO 10993-1:2009
Adopted by: NF EN ISO 10993-1:2004
Adopted by: SN EN ISO 10993-1:2003
Revises: ISO 10993-1:1997

ISO 10993-1:2003

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ISO 10993-1:2018

ISO 10993-1:2009

ISO 10993-1:2003

ISO 10993-1:1997

ISO 10993-1:1992

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ISO 10993-1:2018

ISO 10993-1:2009

ISO 10993-1:2003

ISO 10993-1:1997

ISO 10993-1:1992

Abstract

Products specifications

Product Relations

Product life cycle