Legislation related to this standard
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
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
PUBLISHED
EN 62304:2006/A1:2015
PUBLISHED
EN 62304:2006/corrigendum Nov. 2008
PUBLISHED
EN 62304:2006
IN_DEVELOPMENT
prEN IEC 62304
10.99
New project approved
Feb 19, 2024