BSI - BS EN ISO 10993-1
Biological evaluation of medical devices Part 1: Evaluation and testing
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| Organization: | BSI |
| Publication Date: | 31 July 2009 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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.
NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
Document History
December 31, 2020
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
June 30, 2010
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
June 30, 2010
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
June 30, 2010
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
July 31, 2009
Biological evaluation of medical devices Part 1: Evaluation and testing
A description is not available for this item.
BS EN ISO 10993-1
July 31, 2009
Biological evaluation of medical devices Part 1: Evaluation and testing
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...
October 9, 2003
Biological evaluation of medical devices Part 1: Evaluation and testing
A description is not available for this item.
March 15, 1998
Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
A description is not available for this item.
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