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prSRPS EN IEC 62304:2024

Health software - Software life cycle processes

General information

10.99     Feb 19, 2024

ISS

N062

European Norm

11.040.01  

English  

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

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

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

98/79/EC

In vitro diagnostic medical devices

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN 62304:2009/A1:2017

PUBLISHED
SRPS EN 62304:2009

NOW

PROJECT
prSRPS EN IEC 62304:2024
10.99 New project approved
Feb 19, 2024

Related project

Adopted from prEN IEC 62304 IDENTICAL

Adopted from IEC 62304 ED2 IDENTICAL