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SSH EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Aug 29, 2022

General information

60.60     Aug 29, 2022

DPS

DPS/KT 316

European Norm

03.100.70     11.040.01  

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Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized
Directive 2017/745
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized
Directive 2017/746

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NOW

PUBLISHED
SSH EN ISO 13485:2016/A11:2021
60.60 Standard published
Aug 29, 2022

Related project

Adopted from EN ISO 13485:2016/A11:2021