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Norm

ÖNORM EN ISO 10651-2

Issue date: 2009 09 01

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

This part of ISO 10651 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventil...
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Withdrawn : 2011 07 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 44 Pages
Language:
German | English | Download GER/ENG
Currently valid:
ÖNORM EN ISO 80601-2-72:2024 01 01
Optionally co-design standards:
Committee 179: Medical technology
ICS
11.040.10
Topics
Healthcare, Medical equipment, Anaesthetic, respiratory and reanimation equipment
This part of ISO 10651 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. This part of ISO 10651 is not applicable to cuirass and ¿iron-lung¿ ventilators. This part of ISO 10651 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.
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↖
ÖNORM EN ISO 10651-2
2004 10 01
Lung ventilators for medical use - Particular requirements for basic safety and essential performanc...
Norm
ÖNORM EN 794-2
1997 10 01
Lung ventilators - Part 2: Particular requirements for home care use
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Historie aufklappen
Norm
ISO 10651-2:2004
Issue date : 2004 06 29
Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients
Final Draft
ISO/FDIS 32
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ISO 9360-2:2001
Issue date : 2001 05 10
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Issue date : 2007 02 28
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ISO 14971:2019
Issue date : 2019 12 10
Medical devices — Application of risk management to medical devices
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ISO 15001:2010
Issue date : 2010 05 20
Anaesthetic and respiratory equipment — Compatibility with oxygen
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ISO 15223:2000
Issue date : 2000 04 13
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
Norm
ISO 21647:2004
Issue date : 2004 11 17
Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
Norm
ÖNORM EN ISO 10651-2
Issue date : 2011 07 01
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)