GOST R 54329-2011
Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices

Standard No.
GOST R 54329-2011
Release Date
2011
Published By
RU-GOST R
Latest
GOST R 54329-2011

GOST R 54329-2011 Referenced Document

  • 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

  • 2011 GOST R 54329-2011 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices
Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices



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