BS EN 60601-2-16:2015
Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Standard No.
BS EN 60601-2-16:2015
Release Date
2015
Published By
British Standards Institution (BSI)
Latest
BS EN 60601-2-16:2015
Replace
BS EN 60601-2-16:1998

BS EN 60601-2-16:2015 Referenced Document

  • EN 1040 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)*2023-12-23 Update
  • EN 1275 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)*2023-12-23 Update
  • EN 60601-1-10:2008 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  • EN 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Remains
  • EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Incorporating corrigendum March 2010)
  • EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Inco
  • EN 60601-2-16:1998 Medical Electrical Equipment Part 2-16: Particular Requirements for the Safety of Haemodialysis@ Haemodiafiltration and Haemofiltration Equipment (Incorporating Corrigendum December 1999)
  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • EN ISO 11197 Medical supply units (ISO 11197:2019)*2019-11-27 Update
  • EN ISO 3744 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)*2023-12-23 Update
  • EN ISO 8638 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
  • ISO 11197 Medical supply units*2019-11-07 Update
  • ISO 13958 Concentrates for haemodialysis and related therapies
  • ISO 3744 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
  • ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
  • ISO 8638 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

BS EN 60601-2-16:2015 history

  • 2015 BS EN 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • 1998 BS EN 60601-2-16:1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment



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