BS EN ISO 23640:2015
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- Standard No.
- BS EN ISO 23640:2015
- Release Date
- 2015
- Published By
- British Standards Institution (BSI)
- Latest
- BS EN ISO 23640:2015
- Replace
- BS EN ISO 23640:2013
BS EN ISO 23640:2015 Referenced Document
- 98/79/EC Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
- CLSI EP25-A
- EN 13640 Stability Testing of in Vitro Diagnostic Reagents
- ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
- ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
BS EN ISO 23640:2015 history
- 2015 BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- 2013 BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- 2012 BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- 2002 BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
