EN ISO 13485:2003/AC:2009

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

Current stage: 99.60 Withdrawal effective Feb 15, 2012

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

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

WITHDRAWN
EN ISO 13485:2003/AC:2009
99.60 Withdrawal effective
Feb 15, 2012