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ISO 10993-1:2003

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

Biological evaluation of medical devices Part 1: Evaluation and testing

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

28-11-2018

Superseded by

ISO 10993-1:2009

Language(s)

English, French

Published date

28-07-2003

€60.00
Excluding VAT

ISO 10993-1:2003 describes

  1. the general principles governing the biological evaluation of medical devices;
  2. the categorization of devices based on the nature and duration of their contact with the body;
  3. 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.

DocumentType
Standard
Pages
14
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

Standards Relationship
PNE-EN ISO 10993-1 Identical
BS EN ISO 10993-1:2003 Identical
BS EN ISO 10993-1:June 2009 Identical
UNE-EN ISO 10993-1:2004 Identical

NASA-STD-8719.27:2022 IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials

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