BAS EN ISO 10651-6:2010
Plućni ventilatori za medicinsku primjenu- posebni zahtjevi za osnovnu sigurnost i esencijalne performance-dio 6: pomoćna ventilacijska sredstva za kućnu njegu
Opće informacije
Status: Povučen
Broj strana: 34
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 25.06.2010
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 10651-6:2009, identičan
- ISO 10651-6:2004, identičan