标准编号：ISO 80601-2-69:2014
中文名称：医用电气设备氧浓缩器设备的基本安全和基本性能专用要求
英文名称：Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
发布日期：2014-07
标准范围
IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT‐OPERABLE use by a single PATIENT in various environments including any private and public well as in commerctransportation as ial aircraft. lsucNOTE 1 Such an OXYGEN CONCENTRATOR can ao be sed in professional healthare facilities. This particular standard is applicable to a TRANSIT‐OPERABLE and non‐TRANSIT‐OPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used edical devices, ME EQUIPMwith other mENT or ME SYSTEMS. OXYGEN CONCENTRATORRVING EQUIPMENT [10]EXAMPLE 1 An with integrated oxygen CONSEOXYGEN CONCENTRATOR useor humidifier [4].EXAMPLE 2 An d with a flowmeter stand. EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical ty and anaesthetic gasupplies of electricises. [3] tEXAMPLE 4 An OXYGEN CONCENTRATOR with an inegrated liquid reservoir or gas cylinder filling system. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect theBASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR. This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with aMEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083. 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 ofthe general standard.NOTE 2 See also 4.2 of the General Standard. This International Standard is a particular standard in the IEC 60601‐1 series of standards.
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