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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

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
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