GOST R ISO 14708-1-2012
Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be provided by the manufacturer

Standard No.
GOST R ISO 14708-1-2012
Release Date
2012
Published By
RU-GOST R
Latest
GOST R ISO 14708-1-2012

GOST R ISO 14708-1-2012 Referenced Document

  • IEC 60068-2-14:1984 Basic environmental testing procedures. Part 2 : Tests. Test N: Change of temperature
  • IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
  • IEC 60068-2-47:1999 Environmental testing - Part 2-47: Test methods - Mounting of components, equipment and other articles for vibration, impact and similar dynamic tests
  • IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
  • IEC 60601-1-1:1992 Medical Electrical Equipment Part 1: General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems; (CENELEC EN 60601-1-1: 1993) (Amendment 1-1995) (Edition 1.0)
  • IEC 60601-1-2:1993 Medical electrical equipment; part 1: general requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests
  • IEC 60601-1-4:1996 Appareils Electromedicaux - Partie 1-4: Regles Generales De Securite - Norme Collaterale: Systemes Electromedicaux Programmables (Edition 1.0; Amendment 1: 10-1999)
  • IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
  • IEC 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
  • IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
  • ISO 8601:1988 Data elements and interchange formats — Information interchange — Representation of dates and times

GOST R ISO 14708-1-2012 history

  • 2012 GOST R ISO 14708-1-2012 Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be provided by the manufacturer



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