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SRPS EN ISO 13485:2017/AC:2018

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

Jul 31, 2018

General information

60.60     Jul 31, 2018

ISS

Z210

European Norm

11.040.01     03.100.70  

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Related directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized
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
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

Life cycle

NOW

PUBLISHED
SRPS EN ISO 13485:2017/AC:2018
60.60 Standard published
Jul 31, 2018

Related project

Adopted from EN ISO 13485:2016/AC:2018