BAS EN ISO 10651-2:2010

Plućni ventilatori za medicinsku primjenu – posebni zahtjevi za osnovnu sigurnost i esencijalne performance – dio 2: kućni ventilatori za pacijente ovisne o ventilaciji


Opće informacije
Status: Povučen
Broj strana: 38
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 25.06.2010
Tehnički komitet:
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Apstrakt
ISO 10651-2:2004 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. ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988. ISO 10651-2:2004 is not applicable to cuirass and ''iron-lung'' ventilators. ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients. The requirements of ISO 10651-2:2004 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 10651-2:2009, identičan
  • ISO 10651-2:2004, identičan