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源于可用性标准的讨论

2024-04-21 17:11:12

自《医疗器械可用性工程注册审查指导原则》 发布以来，可用性工程的热度一直不减，在各个三方机构和咨询公司的推波助澜下，外加GB 9706.1三版实施进入正常化下，可用性的相关话题就越发显得热火。对于指导原则有太多解读了，就不去抽这个热闹了，今天来聊聊后台很多小伙伴私信我的一个普遍问题， 就是到底该如何看到可用性的标准。

有这个问题的原因在于目前国内现行有效的可用性工程标准是YY/T 1474-2016 医疗器械可用性工程对医疗器械的应用, 指导原则里也引用了这个标准，但是YY/T 1474-2016 等同转换于IEC 62366:2007，同时指导原则还引用了 IEC 62366-1:2015+A1:2020, Medical devices - Part 1: Application of usability engineering to medical devices， 然后从IEC 62366:2007 到IEC 62366-1:2015+A1:2020，中间还有IEC 62366:2007+A1:2014 和IEC 62366-1:2015，这些版本间的差异显然还是有的，而且指导原则本身不是过程性标准，对于整个可用性过程的展开在细节上没有过多的阐述，因此企业在开展可用性研究的时候还是会回归到标准要求来执行，但是由于标准版本上的差异，已经标准本身跟指导原则上的差异，导致大家对到底该按照什么要求去执行有点迷惑。

好吧，今天咱们就来梳理一下这个可用性工程标准的流程到底有多大差异，差异中寻找平衡点来同时满足指导原则和标准。

先理解一下什么使用的多种方式： 

可以看出所谓的可用性工程其实研究的是正常使用下的使用错误和可合理预见下的使用中非正常使用。

使用错误和可合理预见的非正常使用通过设备的用户界面跟使用者产生交互，进而设备产生非预期的反应，由此可能产生危险或危险情况。

危险和危险情况，那就是我们熟悉的风险管理过程的主要研究对象了，将危险和危险情况结合到产品的风险管理过程中去，进一步分析风险并控制风险， 这就是可用性的设计和实施。

风险管控措施实施后，到底能不能降低使用错误或者可合理预见的非正常使用，进而保证设备的有效性和效率，那就需要有总结性测试来确认。测试完了还需要来看是否有新的使用错误或危险和危险情况产生，是否需要进一步控制或揭露。

大体的可用性过程就是这样，废话不多说了，直接上今天的主题，这四个版本的标准的差异：


YY/T1474-2016
   (IEC 62366:2007 IDT)		IEC  62366:2007+A1:2014IEC 62366-1:2015Gap AnalysisIEC 62366-1:2015+A1:2020
4 *  Principles
4 * Principles

4.1 General requirements
4.1 General requirements

4.1.1 * USABILITY ENGINEERING PROCESSSame4.1.1 USABILITY ENGINEERING PROCESSAdditional requirements：
   1. USABILITY ENGINEERING activities for a MEDICAL DEVICE shall be planned,  carried out, and  documented by  personnel competent on the basis of appropriate education, training, skills or  experience.
   2. Relationship with ISO 13485;
   3. Relationship with ISO 14971		Update the reference standards  revision.
4.1.2 RESIDUAL RISKSame4.1.2 Risk control as it relates to USER  interface designDefine the risk control measure  priority：
   a) inherent SAFETY by design;
   b) protective measures in the MEDICAL DEVICE itself or in the manufacturing  PROCESS;
   c) information for SAFETY. 		a) inherently  safe design and manufacture;
   b) protective measures in the MEDICAL DEVICE itself or in the manufacturing  PROCESS; and
   c) information for SAFETY and, where  appropriate, training to USERS
4.1.3 Information for SAFETYSame4.1.3 Information for SAFETY as it relates to  USABILITYDetail the information as risk  control measure requirement：
   – is perceivable by,
   – is understandable to, and
   – supports CORRECT USE of the MEDICAL DEVICE by
   USERS of the intended USER PROFILES in the context of the intended USE  ENVIRONMENT.		Wording change.
4.2 * USABILITY ENGINEERING FILESame4.2 USABILITY ENGINEERING FILESameSame
4.3 Scaling of the USABILITY ENGINEERING effortSame4.3 Tailoring of the USABILITY ENGINEERING  effortThe usability engineering effort  may vary:
   a) the size and COMPLEXITY of the USER INTERFACE;
   b) the SEVERITY of the HARM associated with the use of the MEDICAL DEVICE;  
   c) the extent or complexity of the USE SPECIFICATION;
   d) the presence of USER INTERFACE OF UNKNOWN PROVENANCE; and
   e) the extent of the modification to an existing MEDICAL DEVICE USER  INTERFACE that had been
   subjected to the USABILITY ENGINEERING PROCESS		Same
5 *  USABILITY ENGINEERING PROCESS
5 * USABILITY ENGINEERING PROCESS

5.1 * Application specification.Same5.1 * Prepare USE SPECIFICATIONSimialr,  “ intended conditions of use” was replaced  by "USE ENVIRONMENT"  and  Application spec was replaced by USE SPEIFICATION.Wording change.
5.2 * Frequently used functionsSameN/ANo such requirement. 
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to  USABILITY



5.3.1 Identification of characteristics related to SAFETYSame
   User profiles+Frequently used functions		5.2 * Identify USER INTERFACE characteristics related to  SAFETY and potential USE ERRORSIdentify USER INTERFACE  characteristics related to safety and POF from particular standard, then  based on them to identify use errors.The results of this  identification of characteristics related to SAFETY and potential  USE ERRORS shall be stored in the USABILITY  ENGINEERING FILE
5.3.2  * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONSSame5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS  SITUATIONSThe identification is simplfied  as:
   During the identification of HAZARDS and HAZARDOUS SITUATIONS, the  following shall be considered:
   – USE SPECIFICATION, including USER PROFILE(S) (see 5.1);
   – information on HAZARDS and HAZARDOUS SITUATIONS known for existing USER  INTERFACES of
   MEDICAL DEVICES of a similar type, if available; and
   – identified USE ERRORS (see 5.2)		Refer to the latest standard of  ISO 14971


5.4 * Identify and describe HAZARD-RELATED USE SCENARIOSHAZARD-RELATED USE SCENARIO  shall include all TASKS and their
   sequences as well as the SEVERITY of the associated HARM.		Same


5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE  EVALUATIONHAZARD-RELATED USE SCENARIOS to  be included in the
   SUMMATIVE EVALUATION		The summative evaluation shall  include:
   – all HAZARD-RELATED USE SCENARIOS; or
   – a subset of the HAZARD-RELATED USE SCENARIOS  based on the SEVERITY of the potential HARM that could be caused by USE ERROR  (e.g. for which medical intervention would be
   needed); or
   – a subset of the HAZARD-RELATED USE SCENARIOS based on the SEVERITY of the  potential HARM and based on other circumstances specific to the MEDICAL  DEVICE and the
   MANUFACTURER. 
5.4 PRIMARY OPERATING FUNCTIONSSameN/A

5.5 *  USABILITY SPECIFICATIONSame5.6 * Establish USER INTERFACE  SPECIFICATIONThe USER INTERFACE SPECIFICATION  shall consider:
   – the USE SPECIFICATION (see 5.1);
   – the known or foreseeable USE ERRORS associated with the MEDICAL DEVICE  (see 5.2); and
   – the HAZARD-RELATED USE SCENARIOS (see 5.4).
   
   The USER INTERFACE SPECIFICATION shall include:
   – testable technical requirements relevant to the USER INTERFACE, including  the requirements
   for those parts of the USER INTERFACE associated with the selected RISK  CONTROL
   measures;
   – an indication as to whether ACCOMPANYING DOCUMENTATION is required;  and
   – an indication as to whether MEDICAL DEVICE-specific training is required.		Same
5.6  USABILITY VALIDATION planSame5.7 * Establish USER INTERFACE EVALUATION plan



5.7.1 GeneralMore detail about the plan  elements.Should consider the USER GROUPS  are intended to be included in the test; 


5.7.2 FORMATIVE EVALUATION planningFORMATIVE EVALUATION  planning:
   a) the evaluation methods being used;
   b) which part of the USER INTERFACE is being evaluated; and
   c) when in the USABILITY ENGINEERING PROCESS to perform each of the USER  INTERFACE EVALUATIONS. 		Same


5.7.3 SUMMATIVE EVALUATION planninga) the evaluation method being  used and a rationale that the method produces OBJECTIVE
   EVIDENCE
   b) which part of the USER INTERFACE is being evaluated;
   c) where applicable, the criteria for determining whether the information  for SAFETY is
   perceivable, understandable and supports CORRECT USE of the MEDICAL DEVICE  (4.1.3);
   d) * the availability of the ACCOMPANYING DOCUMENTATION and provision of  training during the SUMMATIVE EVALUATION; and
   e) * for a USABILITY TEST,
   – the test environment and conditions of use and a rationale for how they  are adequately
   representative of the actual conditions of use;
   – the method of collecting data during the USABILITY TEST for the  subsequent analysis of
   observed USE ERRORS. 		e) * for a USABILITY TEST,  
   – how the characteristics of the test participants are  representative of the intended USER PROFILES;
   – justifying how the test participants are grouped into distinct USER  GROUPS for the purpose of determining the number of test participants;
   – the test environment and conditions of use and  a rationale for how they are adequately representative of the intended USE ENVIRONMENT; and
   – the definition of CORRECT USE for each  HAZARD-RELATED USE SCENARIO; and
   – the method of collecting data during the USABILITY TEST for the  subsequent analysis of observed USE ERRORS and use  difficulties. 
5.7  USER INTERFACE design and implementationSame5.8 Perform USER INTERFACE design, implementation and  FORMATIVE EVALUATION FORMATIVE EVALUATION should performed during  the design and implementation to identify the new use error,  HAZARDS, HAZARDOUS SITUATIONS or  HAZARD-RELATED USE
   SCENARIOS.  And the ACCOMPANYING  DOCUMENTATION and training/training materials should be consider during the  USER INTERFACE deisgn.		Same
5.8 *  USABILITY VERIFICATIONSameN/AIt is same as the FORMATIVE  EVALUATION
5.9 *  USABILITY VALIDATIONSame5.9 Perform SUMMATIVE EVALUATION of the USABILITY of the USER  INTERFACETesting: perform a SUMMATIVE EVALUATION of each HAZARD-RELATED USE  SCENARIO selected in 5.5 on the final or production equivalent USER  INTERFACE;
   Data analysis: The  data from the SUMMATIVE EVALUATION shall be analysed to identify the  potential consequences of all USE ERRORS that occurred;
   Follow action: If new  USE ERRORS, HAZARDS, HAZARDOUS SITUATIONS or HAZARD-RELATED USE SCENARIOS are  discovered during the data analysis:
   – if yes, then the MANUFACTURER shall repeat the activities of Clause 5 as  appropriate;
   – if not, the MANUFACTURER shall determine whether further improvement of  the USER
   INTERFACE design as it relates to SAFETY is necessary and practicable.  
   1) if yes, then the MANUFACTURER shall re-enter the USABILITY ENGINEERING  PROCESS at 5.6;
   2) if not, then the MANUFACTURER shall:
   i) document why improvement is not practicable;
   ii) identify the data from the USABILITY ENGINEERING PROCESS needed to  determine the RESIDUAL RISK related to use; and
   iii) evaluate the RESIDUAL RISK according to ISO 14971:2007, 6.4		The MANUFACTURER shall analyse  the data of the SUMMATIVE EVALUATION and shall identify all USE ERRORS and  use difficulties that occurred. If a USE ERROR or use difficulty can lead to  a HAZARDOUS SITUATION, the root cause of any such USE ERROR or use difficulty shall be determined.  The root causes should be determined based on methods including observations  of USER performance as well as subjective comments from the USER.

5.10 USER INTERFACE OF UNKNOWN  PROVENANCE (UOUP)5.10 USER INTERFACE OF UNKNOWN PROVENANCERefer to Annex CSame
6 *  ACCOMPANYING DOCUMENTSame
Combined it to above process
7 *  Training and materials for trainingSame
Combined it to above process

Annex K Evaluation of a USER  INTERFACE OF
   UNKNOWN PROVENANCE (UOUP)		Annex C Evaluation of a USER  INTERFACE OF
   UNKNOWN PROVENANCE (UOUP)


K.1 GeneralC.1 GeneralSameSame

K.2 USABILITY ENGINEERING  PROCESS for USER INTERFACE OF UNKNOWN PROVENANCEC.2 USABILITY ENGINEERING  PROCESS for USER INTERFACE OF UNKNOWN
   PROVENANCE


K.2.1 * Application  specificationC.2.1 * USE SPECIFICATIONSimialr,  Application spec was replaced by USE  SPEIFICATION.Same

K.2.2 PRIMARY OPERATING  FUNCTIONSN/APOF refer to particular standardSame

K.2.3 * Review of  post-production informationC.2.2 * Review of  POST-PRODUCTION informationSameSame

K.2.4 HAZARDS AND HAZARDOUS  SITUATIONS caused by USABILITY problemsC.2.3 HAZARDS and HAZARDOUS  SITUATIONS related to USABILITYdelete POFSame

K.2.5 RISK CONTROLC.2.4 RISK CONTROLSameSame

K.2.6 RESIDUAL RISK evaluationC.2.5 RESIDUAL RISK evaluationSameSame

K.2.7 ACCOMPANYING DOCUMENTN/ACombined it to above process





SummaryNew added UOUP should follow the  Annex K to be evaluated.
Delete Frequently used functions  and POF identification，merge them to   USE SPEIFICATION. The HAZARD-RELATED USE SCENARIOS identification is  important during the Usability engineering process. Detail Formative and Summative  EVALUATIONRefer to the latest revsion of  ISO 14971 and add more requiements about the summative testing, such as the  user group and use difficulty.


来源：包总