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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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    51

    Published ISO standards *

    21

    ISO standards under development *

    29
    Participating members
    8
    Observing members

    * number includes updates

    Reference Title Type
    ISO/TC 121/SC 3/JWG 1   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators Working group
    ISO/TC 121/SC 3/JWG 2   Joint ISO/TC 121/SC 3-IEC/SC 62A WG : Alarm systems Working group
    ISO/TC 121/SC 3/JWG 5   Joint ISO/TC 121/SC 1 and SC 3-IEC/SC 62A WG : Physiologic closed-loop controllers Working group
    ISO/TC 121/SC 3/JWG 6   Joint ISO/TC121/SC 3 - IEC/SC/62A JWG 6: Medical electrical equipment and medical electrical systems used in home care application Working group
    ISO/TC 121/SC 3/JWG 7   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Non-invasive blood pressure monitoring equipment Working group
    ISO/TC 121/SC 3/JWG 8   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Clinical Thermometers Working group
    ISO/TC 121/SC 3/JWG 10   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Oximeters Working group
    ISO/TC 121/SC 3/JWG 11   Joint ISO/TC 121/SC 1 and SC 3-IEC/SC 62A WG: Emergency medical services equipment Working group
    ISO/TC 121/SC 3/JWG 12   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Home respiratory equipment Working group
    ISO/TC 121/SC 3/JWG 14   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Electromedical diagnostic and patient monitoring equipment Working group
    ISO/TC 121/SC 3/WG 13   Biocompatibility of respiratory gas pathways Working group
    Liaison Committees to ISO/TC 121/SC 3

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

    Reference Title ISO/IEC
    IEC/SC 62D Particular medical equipment, software, and systems IEC
    ISO/TC 121/SC 2 Airway devices and related equipment ISO
    ISO/TC 194 Biological and clinical evaluation of medical devices ISO

     

    Liaison Committees from ISO/TC 121/SC 3

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

    Reference Title ISO/IEC
    ISO/TC 121/SC 1 Breathing attachments and anaesthetic machines ISO
    ISO/TC 121/SC 4 Vocabulary and semantics ISO
    ISO/TC 121/SC 6 Medical gas supply systems ISO
    ISO/TC 121/SC 8 Suction devices ISO

     

    Organizations in liaison (Category A and B)
    Acronym Title Category
    EC - European Commission European Commission A

    Organizations in liaison (Category C)

    C liaisons participate at the level of a Working Group

    Acronym Title Category
    EIGA European Industrial Gases Association C
    IEEE Institute of Electrical and Electronics Engineers, Inc C

    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