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EN 60601-2-16:1998 Standard

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  Keywords:

#medical #patient #either #staff #supervision

This standard can be totally or partially supervised by:
  •   EN 60601-2-16:1998/AC:1999
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipmentIEC 60601-2-16:1998

      Purpose

    This Particular Standard specifies the minumum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment (as defined in 2.101). These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.

      Publication

    Friday 17th of November 2017

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