EN ISO 13485:2012/AC:2012

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009) EN ISO 13485:2012/AC:2012

General information

Current stage: 99.60 Withdrawal effective Mar 2, 2016

Originator: CEN/CENELEC

Owner: CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Type: European Norm

ICS: 03.100.70 Management systems | 11.040.01 Medical equipment in general

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

Legislation 98/79/EC

93/42/EEC

Medical devices

Harmonized/Supporting

Legislation 93/42/EEC

90/385/EEC

Active implantable medical devices

Harmonized/Supporting

Legislation 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

Legislation 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 13485:2012

NOW

WITHDRAWN
EN ISO 13485:2012/AC:2012
99.60 Withdrawal effective
Mar 2, 2016

REVISED BY

PUBLISHED
EN ISO 13485:2016