CSA序言这是CSA C22.2第60601-1-11号的合并版本2.1，医疗电气设备-第1-11部分:基本安全和基本性能的一般要求-附带标准:家庭医疗环境中使用的医疗电气设备和医疗电气系统的要求，这是一种采用，带有加拿大偏差，标题相同的IEC（国际电工委员会）标准60601-1-11（版本2:2015与修订件1:2020合并）。它取代了2011年发布的第一版，即CAN/CSA-C22.2第60601-1-11号（采用IEC 60601-1-11:2010）。它是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。 为简洁起见，本标准通篇称为“CSA C22.2 No.60601-1-11”。本标准拟与CAN/CSA-C22.2 No.60601-1:14《医用电气设备-第1部分:基本安全和基本性能的一般要求》（采用IEC 60601-1:2005，包括修改件1:2012，带加拿大偏差）一起使用。如果本合并版与出版版及其修订版之间存在差异，则以这些文件为准。本标准被认为适用于本标准规定范围内的合格评定。本标准由CSA消费品和商业产品技术委员会审查通过，由CSA电气安全要求战略指导委员会管辖，并已由技术委员会正式批准。 由于本标准的医疗内容，本标准还得到了CSA医疗保健用电技术委员会的批准，该委员会隶属于CSA医疗保健技术和系统战略指导委员会。本标准是根据加拿大标准委员会对加拿大国家标准的要求制定的。CSA集团已将其发布为加拿大国家标准。范围和目标1.1*范围本国际标准适用于家庭医疗环境中使用的医疗电气设备和医疗电气系统的基本安全和基本性能，如3所定义。 制造商在使用说明书中规定。无论医用电气设备或医用电气系统是供非专业操作员使用还是供受过培训的医疗保健人员使用，本国际标准均适用。家庭医疗环境包括:-患者居住的地方；-其他室内和室外都有患者的地方，不包括专业医疗设施环境，在这些环境中，当患者在场时，接受过医疗培训的操作员可以继续使用。本国际标准不适用于IEC 60601涵盖的仅用于紧急医疗服务环境的医用电气设备和医用电气系统- 1-12或仅用于IEC 60601-1涵盖的专业医疗机构，无需添加IEC 60601-1-12或本附带标准。尽管如此，医用电气设备或医用电气系统可用于多种使用环境，因此，如果也用于家庭医疗环境，则在本标准的范围内。例如，适用于家庭医疗环境和专业医疗设施环境的医用电气设备或医用电气系统。注:家庭医疗环境医用电气设备和医用电气系统经常用于电源不可靠和电气接地不良的位置。 1.2目的本附带标准的目的是规定除一般标准外的一般要求，并作为特定标准的基础。

CSA PrefaceThis is consolidated edition 2.1 of CSA C22.2 No. 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-11 (edition 2:2015 consolidated with Amendment 1:2020). It supersedes the first edition published in 2011 as CAN/CSA-C22.2 No. 60601-1-11 (adopted IEC 60601-1-11:2010). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CSA C22.2 No. 60601-1-11" throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations). Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence. This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology and Systems. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.Scope and object1.1 * Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. The HOME HEALTHCARE ENVIRONMENT includes: - the dwelling place in which a PATIENT lives; - other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard. EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment. NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.1.2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.