标准编号：ISO 80601-2-12:2020
中文名称：医用电气设备 第2-12部分：危重监护用通风机基本安全和基本性能的特殊要求
英文名称：Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
发布日期：2020-02
标准范围
This document applies to the basic safety and essential performance of a ventilator in combination
with its accessories, hereafter referred to as ME equipment:
—intended for use in an environment that provides specialized care for patients whose
conditions can be life-threatening and who can require comprehensive care and constant
monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
—intended to be operated by a healthcare professional operator; and
—intended for those patients who need differing levels of support from artificial ventilation
including for ventilator-dependent patients.
A critical care ventilator is not considered to utilize a physiologic closed-loop-control system
unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be
connected to a ventilator breathing system, or to a ventilator, where the characteristics of those
accessories can affect the basic safety or essential performance of the ventilator.
NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
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