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SSH EN ISO 13485:2012/AC:2012

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

Apr 26, 2013
95.99 Withdrawal of Standard   Mar 30, 2016

General information

95.99     Mar 30, 2016

DPS

DPS/KT 316

European Norm

03.100.70     11.040.01     03.120.10  

English  

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Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

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

Medical devices

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

Active implantable medical devices

Harmonized
Directive 90/385/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

NOW

WITHDRAWN
SSH EN ISO 13485:2012/AC:2012
95.99 Withdrawal of Standard
Mar 30, 2016

REVISED BY

PUBLISHED
SSH EN ISO 13485:2016

Related project

Adopted from EN ISO 13485:2012/AC:2012