标准编号：ISO 80601-2-67:2020
中文名称：医用电气设备 第2-67部分：保氧设备的基本安全和基本性能的特殊要求
英文名称：Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
发布日期：2020-10
标准范围
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:
This document is applicable to the basic safety and essential performance of oxygen conserving
equipment, hereafter referred to as ME equipment, in combination with its accessories intended to
conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's
inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is
typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator , an oxygen concentrator or liquid
oxygen equipment .
This document is also applicable to those accessories intended by their manufacturer to be connected to
conserving equipment, where the characteristics of those accessories can affect the basic safety or
essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment
models, as well as between the operation of conserving equipment and continuous flow oxygen
equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is
not applicable to non-active devices (e.g. reservoir cannulas).
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.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except in IEC 60601-
1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
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