STANDARD

Current

ÖNORM EN ISO 80601-2-72

Issue date: 2024 01 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)

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in the home healthcare environment; - intended for use by a lay operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A ventilator is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except for the requirements specified in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. This document does not specify the requirements for: - ventilators or accessories intended for critical care applications, which are given in ISO 80601-2-12; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13; - ventilators or accessories intended for emergency and transport which are given in ISO 80601-2-84; - ventilators or accessories intended for homecare ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and ISO 80601-2-80; - obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70; - high-frequency ventilators, which are given in ISO 80601-2-87. - respiratory high-flow therapy equipment, which are given in ISO 80601-2-90; - user-powered resuscitators, which are given in ISO 10651-4; - gas-powered emergency resuscitators, which are given in ISO 10651-5; - oxygen therapy constant flow ME equipment; and - cuirass and “iron-lung” ventilators.

General information on ÖNORM EN ISO 80601-2-72

Format

Paper | 167 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 80601-2-72 from 1997 til today.

ÖNORM EN ISO 80601-2-72

2024 01 01 Standard ÖNORM EN ISO 80601-2-72, Edition: 2024 01 01

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential per...
ÖNORM EN ISO 80601-2-72

2016 03 01 Standard ÖNORM EN ISO 80601-2-72, Edition: 2016 03 01

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential per...
ÖNORM EN ISO 10651-2

2011 07 01 Standard ÖNORM EN ISO 10651-2, Edition: 2011 07 01

Lung ventilators for medical use - Particular requirements for basic safety and essential performanc...
ÖNORM EN ISO 10651-2

2009 09 01 Standard ÖNORM EN ISO 10651-2, Edition: 2009 09 01

Lung ventilators for medical use - Particular requirements for basic safety and essential performanc...
ÖNORM EN ISO 10651-2

2004 10 01 Standard ÖNORM EN ISO 10651-2, Edition: 2004 10 01

Lung ventilators for medical use - Particular requirements for basic safety and essential performanc...
ÖNORM EN 794-2

1997 10 01 Standard ÖNORM EN 794-2, Edition: 1997 10 01

Lung ventilators - Part 2: Particular requirements for home care use

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 14937:2009	Titel Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2009 10 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 17664-1:2021	Titel Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices	Ausgabedatum 2021 07 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 17664-2:2021	Titel Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices	Ausgabedatum 2021 02 25	Art Standard	Zur Produktseite
Dokumentnummer ISO 18562-1:2017	Titel Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process	Ausgabedatum 2017 03 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 20417:2021	Titel Medical devices — Information to be supplied by the manufacturer (Corrected version 2021-12)	Ausgabedatum 2021 04 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 23328-1:2003	Titel Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance	Ausgabedatum 2003 08 20	Art Standard	Zur Produktseite
Dokumentnummer ISO 23328-2:2002	Titel Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects	Ausgabedatum 2002 10 22	Art Standard	Zur Produktseite
Dokumentnummer ISO 32:1977	Titel Gas cylinders for medical use — Marking for identification of content	Ausgabedatum 1977 05 01	Art Standard	Zur Produktseite
Dokumentnummer ISO 3744:2010	Titel Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane	Ausgabedatum 2010 09 22	Art Standard	Zur Produktseite
Dokumentnummer ISO 4871:1996	Titel Acoustics — Declaration and verification of noise emission values of machinery and equipment	Ausgabedatum 1996 12 19	Art Standard	Zur Produktseite
Dokumentnummer ISO 5356-1:2015	Titel Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets	Ausgabedatum 2015 03 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 5359:2014	Titel Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases	Ausgabedatum 2014 09 30	Art Standard	Zur Produktseite
Dokumentnummer ISO 5637:1989	Titel Paper and board — Determination of water absorption after immersion in water	Ausgabedatum 1989 11 02	Art Standard	Zur Produktseite
Dokumentnummer ISO 7396-1:2016	Titel Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum	Ausgabedatum 2016 02 15	Art Standard	Zur Produktseite
Dokumentnummer ISO 80369-1:2018	Titel Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements	Ausgabedatum 2018 11 05	Art Standard	Zur Produktseite
Dokumentnummer ISO 80601-2-55:2018	Titel Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors	Ausgabedatum 2018 02 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 80601-2-74:2021	Titel Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment	Ausgabedatum 2021 07 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 9360-1:2000	Titel Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml	Ausgabedatum 2000 03 16	Art Standard	Zur Produktseite
Dokumentnummer ISO 9360-2:2001	Titel Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml	Ausgabedatum 2001 05 10	Art Standard	Zur Produktseite

ÖNORM EN ISO 80601-2-72

General information on ÖNORM EN ISO 80601-2-72

Timeline

Frequently Asked Questions about ÖNORM EN ISO 80601-2-72

Normative References

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ISO/TS 11819-3:2021

ÖNORM EN ISO 105-Z04

ÖNORM EN ISO 21805

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ÖNORM EN ISO 80601-2-72

General information on ÖNORM EN ISO 80601-2-72

Timeline

Frequently Asked Questions about ÖNORM EN ISO 80601-2-72

Normative References

Recently Viewed

ISO/TS 11819-3:2021

ÖNORM EN ISO 105-Z04

ÖNORM EN ISO 21805

Customize and purchase single-user license

Subscribe to standards

Regarding the newly released ISO 9001, we recommend: