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

标准号

DIN EN ISO 10651-2:2011

发布

2011年

发布单位

德国标准化学会

当前最新

DIN EN ISO 10651-2:2011

 

 

引用标准

IEC 60097-4 IEC 60601-1-2 IEC 60601-1-6 IEC 60601-1-8:2003 IEC 60601-1:1988 ISO 14937 ISO 14971 ISO 15001 ISO 15223:2000 ISO 21647 ISO 32 ISO 4135 ISO 5356-1 ISO 5356-2 ISO 5359 ISO 5362 ISO 5367 ISO 7396-1 ISO 8185 ISO 9360-1 ISO 9360-2 ISO 9919

被代替标准

DIN EN ISO 10651-2:2009

适用范围

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.

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