Standard

NS-EN ISO 10993-10:2010

Nov 2010 Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-10:2023

Corrigendums and amendments are bought separately.

Language English

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Abstract

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.ISO 10993-10:2010 includes:pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Document information

Standard from SN
Published: 1 November 2010
Withdrawn: 1 November 2013
Edition: 2010-08
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 109

Legal references

EU law: 93/42/EEC, 90/385/EEC, 2007/47/EC

Product Relations

Replaced by: NS-EN ISO 10993-10:2013
Replaces: NS-EN ISO 10993-10:2009
Adopted from: EN ISO 10993-10:2010 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-10:2009
Current product

Withdrawn

NS-EN ISO 10993-10:2010
Replaced by

Withdrawn

NS-EN ISO 10993-10:2013

NS-EN ISO 10993-10:2010

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NS-EN ISO 10993-10:2023

NS-EN ISO 10993-10:2013