GOST R 54329-2011 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices
GOST R 51609-2000 Medical products. Classification in accordance with potential risk of using. General requirements
GOST R ISO 15223-2002 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied
GOST R ISO/IEC 17050-1-2009 Conformity assessment. Supplier's declaration of conformity. Part 1. General requirements
GOST R ISO/TR 16142-2008 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
GOST R 54329-2011 history
2011GOST R 54329-2011 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices