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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 9703-3:1999

Status: VIGENTE / 1999-10-20

ANAESTHETIC AND RESPIRATORY CARE ALARM SIGNALS. PART 3: GUIDANCE ON APPLICATION OF ALARMS (ISO 9703-3:1998)

UNE-EN 475:1996

Status: VIGENTE / 1996-02-15

MEDICAL DEVICES. ELECTRICALLY-GENERATED ALARM SIGNALS.

UNE-EN ISO 80601-2-13:2013

Status: ANULADA / 2025-07-01

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

UNE-EN ISO 80601-2-13:2013/A1:2020

Status: ANULADA / 2025-07-01

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)

UNE-EN ISO 80601-2-13:2013/A2:2020

Status: ANULADA / 2025-07-01

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)

UNE-EN ISO 18562-1:2020 (Ratificada)

Status: ANULADA / 2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017) (Endorsed by Asociación Española de Normalización in April of 2020.)

UNE-EN ISO 18562-2:2020 (Ratificada)

Status: ANULADA / 2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017) (Endorsed by Asociación Española de Normalización in April of 2020.)

UNE-EN ISO 18562-3:2020 (Ratificada)

Status: ANULADA / 2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017) (Endorsed by Asociación Española de Normalización in April of 2020.)

UNE-EN ISO 18562-4:2020 (Ratificada)

Status: ANULADA / 2025-05-07

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017) (Endorsed by Asociación Española de Normalización in April of 2020.)

UNE-EN ISO 5362:2020

Status: ANULADA / 2025-01-22

Anaesthetic reservoir bags (ISO 5362:2006)

UNE-EN ISO 80601-2-12:2021

Status: ANULADA / 2025-01-22

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)

UNE-EN 794-3:1999+A2:2010

Status: ANULADA / 2025-01-22

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

UNE-EN ISO 4135:2023

Status: ANULADA / 2024-11-27

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

UNE-EN ISO 19223:2022

Status: ANULADA / 2024-11-27

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

UNE-EN ISO 80601-2-79:2019 (Ratificada)

Status: ANULADA / 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 80601-2-79:2018) (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN ISO 80601-2-80:2019 (Ratificada)

Status: ANULADA / 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 80601-2-80:2018) (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN ISO 5367:2015

Status: ANULADA / 2024-05-22

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)

UNE-EN ISO 15002:2008

Status: ANULADA / 2024-05-01

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

UNE-EN ISO 15002:2008/A1:2020

Status: ANULADA / 2024-05-01

Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 1 (ISO 15002:2008/Amd 1:2018)

UNE-EN ISO 27427:2020

Status: ANULADA / 2024-03-20

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)

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