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
Опште информације
Статус: Повучен
Број страна: 38
Језик: Енглески
Издање: 2.
Метода усвајања: Proglašavanje
Датум објаве: 25.06.2010
Технички комитет:
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Апстракт
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.
Животни циклус
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Изворни документ и степен усаглашености
- EN ISO 10651-2:2009, идентичан
- ISO 10651-2:2004, идентичан