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Full Description

This standard specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient.
 

Document History

  1. AAMI/IEC 60601-2-16:2018

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    Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

    • Most Recent
  2. AAMI/IEC 60601-2-16:2012


    Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

    • Historical Version
  3. AAMI/IEC 60601-2-16:2008


    Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

    • Historical Version
  4. AAMI RD5:2003 (R2008)


    Hemodialysis Systems

    • Historical Version
  5. AAMI RD5-92


    Hemodialysis Systems

    • Historical Version