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SRPS EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Oct 31, 2018

General information

60.60     Oct 31, 2018

ISS

Z076

European Norm

11.100.20  

English  

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Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-11:2011

NOW

PUBLISHED
SRPS EN ISO 10993-11:2018
60.60 Standard published
Oct 31, 2018

REVISED BY

PROJECT
naSRPS EN ISO 10993-11:2023

Related project

Adopted from EN ISO 10993-11:2018

Adopted from ISO 10993-11:2017