BAS EN ISO 10651-6:2010
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices
General Information
Status: Withdrawn
No. of pages: 34
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
The requirements of ISO 10651-6:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10651-6:2009, identical
- ISO 10651-6:2004, identical