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Scope

Standardisation of the particular requirements for basic safety and essential performance of medical devices and their accessories intended for ventilatory support, delivery of respiratory gases and related monitoring of patients. This includes dosing and conditioning of the gases supplied to or inhaled by the patient. These medical devices can be intended for use in specific, particular or defined healthcare environments, including home healthcare environments. These medical devices are generally active, reusable electromedical equipment (i.e. durable) with accessories that mainly are for single-patient use. ISO/TC 121/SC 3 is also responsible for the biological evaluation of gas pathways in all environments. Further, ISO/TC 121/SC 3, in co-operation with IEC/TC 62 Subcommittees utilizing Joint Working Groups, is responsible for the standardisation of the horizontal requirements for basic safety and essential performance of medical electrical equipment used in:

  • emergency medical services;
  • home healthcare environments;
  • alarm systems in all environments; and
  • physiological closed-loop control in all environments.
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    53

    Published ISO standards *

    17

    ISO standards under development *

    29
    Participating members
    9
    Observing members

    * number includes updates

    Liaison Committees to ISO/TC 121/SC 3

    The committees below can access the documents of ISO/TC 121/SC 3:

     

    Liaison Committees from ISO/TC 121/SC 3

    ISO/TC 121/SC 3 can access the documents of the committees below:

     

    Organizations in liaison (Category A and B)

    Organizations in liaison (Category C)

    C liaisons participate at the level of a Working Group

    ISO/TC 121/SC 3 - Secretariat

    ANSI (United States)

    Association for the Advancement of Medical Instrumentation
    901 N. Glebe Road, Suite 300
    Arlington 22203 VA
    United States

    Tel: +1 703 525 48 90
    Fax: +1 703 276 07 93