Standard

NS-EN ISO 10993-11:2006

Dec 2006 Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-11:2018

Corrigendums and amendments are bought separately.

Language English

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Abstract

This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.

Document information

Standard from SN
Published: 1 December 2006
Withdrawn: 1 July 2009
Edition: 2006-08
Version: 1
Document type: NAT
ISBN:

ICS 11.100
ICS 11.100.01
National Committee SN/K 115

Legal references

EU law: 90/385/EEC, 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 10993-11:2009
Replaces: NS-EN ISO 10993-11:1995
Adopted from: EN ISO 10993-11:2006 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-11:1995
Current product

Withdrawn

NS-EN ISO 10993-11:2006
Replaced by

Withdrawn

NS-EN ISO 10993-11:2009

NS-EN ISO 10993-11:2006

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NS-EN ISO 10993-11:2018

NS-EN ISO 10993-11:2009