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prEN IEC 62304

Medical device software - Software life cycle processes prEN IEC 62304

General information

10.99 New project approved   Feb 19, 2024

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.01   Medical equipment in general

Related legislation

Legislation related to this standard

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

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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

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Life cycle

PREVIOUSLY

PUBLISHED
EN 62304:2006/A1:2015

PUBLISHED
EN 62304:2006/corrigendum Nov. 2008

PUBLISHED
EN 62304:2006

NOW

IN_DEVELOPMENT
prEN IEC 62304
10.99 New project approved
Feb 19, 2024