Sobre

Alcance

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.
  • Enlaces rápidos

    53

    Normas ISO publicadas *

    16

    Normas ISO en desarrollo *

    29
    Miembros participantes
    8
    Miembros observadores

    * la cifra incluye las actualizaciones

    Referencia Título Tipo
    ISO/TC 121/SC 3/AG   Marketing Grupo de trabajo
    ISO/TC 121/SC 3/JWG 1   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators Grupo de trabajo
    ISO/TC 121/SC 3/JWG 2   Joint ISO/TC 121/SC 3-IEC/SC 62A WG : Alarm systems Grupo de trabajo
    ISO/TC 121/SC 3/JWG 5   Joint ISO/TC 121/SC 1 and SC 3-IEC/SC 62A WG : Physiologic closed-loop controllers Grupo de trabajo
    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 Grupo de trabajo
    ISO/TC 121/SC 3/JWG 7   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Non-invasive blood pressure monitoring equipment Grupo de trabajo
    ISO/TC 121/SC 3/JWG 8   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Clinical Thermometers Grupo de trabajo
    ISO/TC 121/SC 3/JWG 10   Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Oximeters Grupo de trabajo
    ISO/TC 121/SC 3/JWG 11   Joint ISO/TC 121/SC 1 and SC 3-IEC/SC 62A WG: Emergency medical services equipment Grupo de trabajo
    ISO/TC 121/SC 3/JWG 12   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Home respiratory equipment Grupo de trabajo
    ISO/TC 121/SC 3/JWG 14   Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Electromedical diagnostic and patient monitoring equipment Grupo de trabajo
    ISO/TC 121/SC 3/WG 5   Gas flow measurement and control Grupo de trabajo
    ISO/TC 121/SC 3/WG 13   Biocompatibility of respiratory gas pathways Grupo de trabajo
    Comités de enlace a ISO/TC 121/SC 3

    Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 121/SC 3:

    Referencia Título 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

     

    Comités de enlace de ISO/TC 121/SC 3

    ISO/TC 121/SC 3 pueden acceder a los documentos de los comités que aparecen a continuación:

    Referencia Título 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

     

    Organizaciones de enlace (categorías A y B)
    Sigla Título Categoría
    EC - European Commission European Commission A

    Organizaciones de enlace (categoría C)

    Los enlaces C participan a nivel de grupo de trabajo

    Sigla Título Categoría
    EIGA European Industrial Gases Association C
    IEEE Institute of Electrical and Electronics Engineers, Inc C
    Fecha Mes Ubicación TC/SC Nota
    20-24 January 2025 Auckland (New Zealand) ISO/TC 121/SC 3  

    * Información definitiva, pero la reunión aún no se ha convocado formalmente
    ** Provisional

    ISO/TC 121/SC 3 - Secretaría

    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