NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 13408-6 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 14644-7 2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 More 
EUV 2017/745 2017-04-05 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 More 
EUV 2017/746 2017-04-05 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 More 
ISO 10648-1 1997-05 Containment enclosures - Part 1: Design principles More 
ISO 10648-2 1994-12 Containment enclosures - Part 2: Classification according to leak tightness and associated checking methods More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More