IEC 62366-1:2015+A1:2020 Medical Device Part 1 Application of usability engineering to medical devices 医疗器械第1部分可用性工程对医疗器械的应用 英文中文对照版 1范围 Scope This part of IEC 62366 specifies a PROcEss for a MANUFAcTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. It can be used to identify but does not assess or mitigate RISKs associated with ABNORMAL UsE. IEC62366的第1部分规定了制造商分析、确定、开发和评价安全相关的医疗器械可用性的过 程。该可用性工程（人因工程）过程用于制造商评估并降低由正确使用和使用错误相关的风 险。能用于识别但不用于评估或降低非正常使用相关的风险。 ERRoR, which can lead to exposure to HAZARDs or including loss degradation of clinical performance. 注意1：无不可接受的风险即安全。不可接受的风险可能来自于使用错误，它可导致直接的身体 伤害或临床功能损失/退化。 NOTE Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICEs is available in IEC TR 62366-2, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY. 涉及与安全无关的其他可用性方面。 If the USABILITY ENGINEERING PROCEss detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. 如果已经符合本标准中详细描述的可用性工程过程，那么假定“安全”相关的医疗器械的可用性是 可接受的，除非有相反的客观证据。 NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POsT-PRODUcTION surveillance 注意3：这样的客观证据可源于生产后监督。 1 / 94 IEC 62366-1:2015+A1:2020 Medical Device Part 1 Application of usability engineering to medical devices 医疗器械第1部分可用性工程对医疗器械的应用 英文中文对照版 2 规范性引用文件 Normative references The following documents, in whole or in part, are normatively referenced in this document and undated references, the latest edition of the referenced document (including any amendments) applies. 下列文件对本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文 件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。 NoTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. 注意1：这些引用文件在规范性要求中的引用方式决定了其适用范围（全部或部分）。 注意2：资料性引用文件列在第55页开始的参考文献中。 IsO 14971:2019, Medical devices - Application of risk management to medical devices ISO14971:2019医疗器械风险管理对医疗器械的应用 3 术语和定义 Terms and definitions For the purpose of this document, the terms and definitions given in isO 14971:2019 and the following apply. ISO14971:2019中界定的术语和定义以及下列术语和定义适用于本文件。 NOTE An index of defined terms is found beginning on page 49 注意：定义术语的索引见第49页。 3.1 ABNORMAL USE conscious, deliberate act or deliberate omission of an act that is counter to or violates NoRMAL USE and is also beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER. 2 / 94 IEC 62366-1:2015+A1:2020 Medical Device Part 1 Application of usability engineering to medical devices 医疗器械第1部分可用性工程对医疗器械的应用 英文中文对照版 3.1非正常使用 医疗器械的责任方或用户有意识的、故意的行为或故意不作为，其行为结果超出制造商所有合 理的风险控制措施。 EXAMPLEs Reckless use or sabotage or deliberate disregard of information for sAFETY are such acts. 例如：使用粗心、破坏或故意无视安全的信息的行为。 NoTE 1 to entry See also 4.1.3. 注意1：见4.1.3（可用性相关的安全信息） NoTE 2 to entry: An intended but erroneous action that is not ABNORMAL UsE is considered a type of USE ERROR. 注意2：刻意的错误行为不是非正常使用，而是一种使用错误。 INTERFACE -related means of RISK CONTROL. 注意3：非正常使用并不能解除制造商对非用户接口相关的风险控制的考虑。 NoTE 4 to entry: Figure 1 shows the relationships of the types of use. 注意4：图1显示了使用类型之间的关系。 医疗器械使用 MEDICALDEVICEUSe 正常使用 NORMALUSE 正确使用 CORRECTUSE USEERROR 使用错误 ABNORMALUSE 不正常使用 Figure 1 - Relationship of the types of use 图1-用户类型之间的关系 3 / 94