CSA C22.2 No.80601-2-67-2023

Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

CSA C22.2 No.80601-2-67-2023 发布历史

CSA C22.2 No.80601-2-67-2023由SCC 发布于 2023-03-01。

CSA C22.2 No.80601-2-67-2023在国际标准分类中归属于: 11.040.10 麻醉、呼吸和复苏设备。

CSA C22.2 No.80601-2-67-2023 的最新版本是哪一版？

最新版本是 CSA C22.2 No.80601-2-67-2023 。

CSA C22.2 No.80601-2-67-2023的历代版本如下：

• 2023年 CSA C22.2 No.80601-2-67-2023

Scope 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[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. 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.

标准号

CSA C22.2 No.80601-2-67-2023

发布

2023年

发布单位

SCC

当前最新

CSA C22.2 No.80601-2-67-2023

 

 

代替标准

11.040.10

被代替标准

CAN/CSA-C22.2 No. 80601-2-67:17

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