CSA序言这是CAN/CSA-C22的合并版3.2。2第60601-1-6号，医用电气设备-第1-6部分:基本安全和基本性能的一般要求-附带标准:可用性，采用了相同名称的IEC（国际电工委员会）标准60601-1-6（3:2010版，合并修订件1:2013和修订件2:2020），但存在加拿大偏差。它取代了2008年出版的第二版CAN/CSA-C22。2编号60601-1-6（采用IEC 60601-1-6:2006）。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“CAN/CSA-C22.2编号60601-1-6”。本标准旨在与CAN/CSA结合使用- 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，带有加拿大偏差）。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。本标准适用于本标准规定范围内的合格评定。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。CSA集团已将其作为加拿大国家标准发布。范围和目标1.1*范围本国际标准规定了制造商分析、规定、开发和评估可用性的过程，因为它涉及医用电气设备（以下简称医用电气设备）的基本安全和基本性能。 此可用性工程过程评估并减轻与正确使用和使用错误（即正常使用）相关的可用性问题所造成的风险。它可用于识别但不评估或减轻与异常使用相关的风险。如果已遵守本附带标准中详细说明的可用性工程过程，则医用电气设备的可用性（与基本安全和基本性能相关）被认为是可接受的，除非有客观证据相反。注:此类客观证据可能随后来源于后期生产监控。1.2目的本附随标准的目的是规定除一般标准外的一般要求，并作为特殊标准的基础。

CSA PrefaceThis is consolidated edition 3.2 of CAN/CSA-C22.2 No. 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-6 (edition 3:2010 consolidated with Amendment 1:2013 and Amendment 2:2020). It supersedes the second edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1-6 (adopted IEC 60601-1-6:2006). 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 "CAN/CSA-C22.2 No. 60601-1-6" 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 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 object 1.1 *ScopeThis International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.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.