prEN ISO 13485 rev

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

General information

30.98   Project deleted   May 14, 2009

CEN/CENELEC

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

European Norm

03.120.10   Quality management and quality assurance | 11.040.01   Medical equipment in general

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 13485:2003

NOW

ABANDON
prEN ISO 13485 rev
30.98 Project deleted
May 14, 2009