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SN EN ISO 25539-3
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
Edition
2012-03
SN EN 1499
Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2)
Edition
2013-06
SN EN 1500
Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
Edition
2013-06
SN EN ISO 20072
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
Edition
2013-06
SN EN ISO 23500-5
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
Edition
2024-05
EUB 2020/350
Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of firstline assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays
Edition
2020-02-28
EUB 2019/1244
Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays
Edition
2019-07-01
2011/869/EUB
Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices
Edition
2011-12-20
2009/886/EGEntsch
Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices
Edition
2009-11-27
VDI/VDE 3516 Blatt 1
Validation in GxP area - Open-source software
Edition
2013-09
