ISO 8835-5:2004 吸入的麻醉系统-第5部分- 麻醉剂通风器

标准编号:ISO 8835-5:2004

中文名称:吸入的麻醉系统-第5部分- 麻醉剂通风器

英文名称:Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators

发布日期:2004-05

标准范围

ISO 8835-5:2004规定了麻醉呼吸机(定义见3.1)基本性能的特殊要求。ISO 8835-5:2004适用于麻醉呼吸机,该呼吸机始终是麻醉系统的一个组成部分,并由操作员持续监护。ISO 8835-5:2004不适用于附录BB确定的用于易燃麻醉剂的麻醉呼吸机。ISO 8835-5:2004的要求取代或修改了IEC 60601-1:1988及其修正案1(1991)和2(1995)的要求,旨在优先于相应的一般要求。该范围是IEC 60601-1:1988第1条规定范围之外的附加范围,上述情况除外。

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.The requirements of ISO 8835-5:2004 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.This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

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