Committee

Committee:

CTN 110 - Anaesthetic and respiratory equipment

Secretary:
FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA
Field of Activity:
Standardization of:

Anaesthetic and respiratory equipment concerning terminology, dimensional and design specifications, and provision for mounting connectors to ensure interchangeability (or interchangeability for safety requirements) as well as other applicable requirements.
International Relations:

ISO/TC 121  Anaesthetic and respiratory equipment

CEN/TC 215  Respiratory and anaesthetic equipment

Standards developed by the committee: CTN 110: 291

UNE-EN ISO 18562-1:2025

Status: VIGENTE /  2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)

UNE-EN ISO 18562-2:2025

Status: VIGENTE /  2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)

UNE-EN ISO 18562-3:2025

Status: VIGENTE /  2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)

UNE-EN ISO 18562-4:2025

Status: VIGENTE /  2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)

UNE-EN ISO 5362:2025

Status: VIGENTE /  2025-01-22

Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)

UNE-EN ISO 80601-2-12:2025

Status: VIGENTE /  2025-01-22

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)

UNE-EN ISO 80601-2-84:2025

Status: VIGENTE /  2025-01-22

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)

UNE-EN ISO 4135:2024

Status: VIGENTE /  2024-11-27

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)

UNE-EN ISO 19223:2024

Status: VIGENTE /  2024-11-27

Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)

UNE-EN ISO 16571:2024

Status: VIGENTE /  2024-11-27

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)

UNE-EN ISO 80601-2-79:2024 (Ratificada)

Status: VIGENTE /  2024-10-01

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024) (Endorsed by Asociación Española de Normalización in October of 2024.)

UNE-EN ISO 80601-2-80:2024 (Ratificada)

Status: VIGENTE /  2024-10-01

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024) (Endorsed by Asociación Española de Normalización in October of 2024.)

UNE-EN ISO 10524-1:2019/A1:2024

Status: VIGENTE /  2024-06-05

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1 (ISO 10524-1:2018/Amd 1:2023)

UNE-EN ISO 5367:2024

Status: VIGENTE /  2024-05-22

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)

UNE-EN ISO 15002:2024 (Ratificada)

Status: VIGENTE /  2024-05-01

Flow control devices for connection to a medical gas supply system (ISO 15002:2023) (Endorsed by Asociación Española de Normalización in May of 2024.)

UNE-EN ISO 27427:2024

Status: VIGENTE /  2024-03-20

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)

UNE-EN ISO 10651-4:2023

Status: VIGENTE /  2024-01-03

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)

UNE-EN ISO 80601-2-55:2018/A1:2023 (Ratificada)

Status: VIGENTE /  2024-01-01

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023) (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-EN ISO 5361:2023

Status: VIGENTE /  2023-12-13

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)

UNE-EN ISO 21917:2023

Status: VIGENTE /  2023-09-20

Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)

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