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About This Item

 

Full Description

Adopts IEC 60601-2-16, Ed.4.0 to specify basic safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment. It does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. To be read in conjunction with AS/NZSIEC60601.1:2015.
 

Document History

  1. AS/NZS IEC 60601.2.16:2015

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    Medical electrical equipment, Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

    • Most Recent
  2. AS/NZS 3200.2.16:1999


    Medical electrical equipment, Part 2.16: Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration equipment

    • Historical Version
  3. AS 3200-1986 AMDT 1


    Approval and test specification - Electromedical equipment - General requirements

    • Historical Version
  4. AS 3200.2.16-1992


    Approval and test specification - Medical electrical equipment, Part 2.16: Particular requirements for safety - Haemodialysis equipment

    • Historical Version
  5. AS 3200-1986


    Approval and test specification - Electromedical equipment - General requirements

    • Historical Version
  6. AS 3207-1981


    Approval and test specification for haemodialysis machines

    • Historical Version
  7. AS 3200-1980


    Approval and test specification - Electromedical equipment - General requirements

    • Historical Version
  8. AS 3200-1978


    Approval and test specification for electromedical equipment - General requirements

    • Historical Version
  9. AS C200-1970


    Approval and test specification for definitions and general requirementsfor electro-medical equipment

    • Historical Version