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SSH EN ISO 13485:2016/AC:2018

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

May 11, 2018

General information

60.60     May 10, 2018

DPS

DPS/KT 316

European Norm

03.100.70     11.040.01  

English  

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Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

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

Medical devices

Harmonized
Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
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
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

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 13485:2016/AC:2016

NOW

PUBLISHED
SSH EN ISO 13485:2016/AC:2018
60.60 Standard published
May 10, 2018

Related project

Adopted from EN ISO 13485:2016/AC:2018