NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 22442-2 [CURRENT] references following documents:

Document number Edition Title
ISO 22442-1 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management More 
DIN EN ISO 22442-3 2008-03 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 More 
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
EUV 722/2012 2012-08-08 Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 22442-3 2007-12 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More 
ISO 9001 2015-09 Quality management systems - Requirements More 
ISO/TR 24971 2020-06 Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) More