GOST R ISO 14708-7-2016
Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems

Standard No.
GOST R ISO 14708-7-2016
Release Date
2016
Published By
RU-GOST R
Latest
GOST R ISO 14708-7-2016

GOST R ISO 14708-7-2016 Referenced Document

  • IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
  • IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
  • IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
  • IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
  • IEC 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
  • IEC 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
  • IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
  • IEC 62304:2006 Medical device software - Software life cycle processes
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14971:2007 Medical devices - Application of risk management to medical devices

GOST R ISO 14708-7-2016 history

  • 2016 GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems



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