Standard

NS-EN ISO 10993-11:2018

Aug 2018 Published

Corrigendums and amendments are bought separately.

Language English

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Abstract

ISO 10993-11:2017 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 information

Standard from SN
Published: 1 August 2018
Edition: 2018-05
Version: 1
Document type: NAT
ISBN:

ICS 11.100
ICS 11.100.01
ICS 11.100.20
National Committee SN/K 115

Legal references

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

Product Relations

Referred by: NS-EN ISO 11608-3:2022
Replaces: NS-EN ISO 10993-11:2009
Adopted from: EN ISO 10993-11:2018 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-11:2009
Current product

Published

NS-EN ISO 10993-11:2018

NS-EN ISO 10993-11:2018

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