Committee:
ISO/TC 121 Anaesthetic and respiratory equipment
CEN/TC 215 Respiratory and anaesthetic equipment
Standards developed by the committee: CTN 110: 291
Status: VIGENTE / 2023-08-01
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023) (Endorsed by Asociación Española de Normalización in August of 2023.)
Status: VIGENTE / 2023-04-12
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
Status: VIGENTE / 2023-02-22
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
Status: VIGENTE / 2023-02-01
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
Status: VIGENTE / 2023-01-01
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)
Status: VIGENTE / 2022-12-21
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
Status: VIGENTE / 2022-11-23
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
Status: VIGENTE / 2022-06-22
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Status: VIGENTE / 2022-05-25
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
Status: VIGENTE / 2022-03-15
Respiratory therapy equipment - Part 2: Tubing and connectors
Status: VIGENTE / 2021-11-24
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
Status: VIGENTE / 2021-11-10
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
Status: VIGENTE / 2021-11-01
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)
Status: VIGENTE / 2021-10-01
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021) (Endorsed by Asociación Española de Normalización in October of 2021.)
Status: VIGENTE / 2021-06-01
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021) (Endorsed by Asociación Española de Normalización in June of 2021.)
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