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NEN-EN-ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

active, Most Current
Organization: NEN
Publication Date: 1 May 2009
Status: active
Page Count: 44
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Document History

NEN-EN-ISO 10993-11
May 1, 2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
September 1, 2006
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
March 1, 2005
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
January 1, 1996
Biological evaluation of medical devices - Part 11: Tests for systematic toxicity
Specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. Includes, in addition, pyrogenicity testing. The methods...

References

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