DIN EN ISO 10651-2-2011 医用肺通气机.基本安全和性能的特殊要求.第2部分:通气机依赖型患者用家庭保健通气机(ISO 10651-2-2004);德文版EN ISO 10651-2-2009
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); German version EN ISO 10651-2:2009
IEC 60601-1:1998, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 specifies requirements for lung ventilators intended for home care applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment. These ventilators are frequently used in locations where driving power is not reliable and are often supervised by non-healthcare personnel with different levels of training.