源于可用性標(biāo)準(zhǔn)的討論

2024-04-21 17:11:12

自《醫(yī)療器械可用性工程注冊(cè)審查指導(dǎo)原則》發(fā)布以來，可用性工程的熱度一直不減，在各個(gè)三方機(jī)構(gòu)和咨詢公司的推波助瀾下，外加GB 9706.1三版實(shí)施進(jìn)入正?；?，可用性的相關(guān)話題就越發(fā)顯得熱火。對(duì)于指導(dǎo)原則有太多解讀了，就不去抽這個(gè)熱鬧了，今天來聊聊后臺(tái)很多小伙伴私信我的一個(gè)普遍問題，就是到底該如何看到可用性的標(biāo)準(zhǔn)。

有這個(gè)問題的原因在于目前國(guó)內(nèi)現(xiàn)行有效的可用性工程標(biāo)準(zhǔn)是YY/T 1474-2016 醫(yī)療器械可用性工程對(duì)醫(yī)療器械的應(yīng)用, 指導(dǎo)原則里也引用了這個(gè)標(biāo)準(zhǔn)，但是YY/T 1474-2016 等同轉(zhuǎn)換于IEC 62366:2007，同時(shí)指導(dǎo)原則還引用了 IEC 62366-1:2015+A1:2020, Medical devices - Part 1: Application of usability engineering to medical devices，然后從IEC 62366:2007 到IEC 62366-1:2015+A1:2020，中間還有IEC 62366:2007+A1:2014 和IEC 62366-1:2015，這些版本間的差異顯然還是有的，而且指導(dǎo)原則本身不是過程性標(biāo)準(zhǔn)，對(duì)于整個(gè)可用性過程的展開在細(xì)節(jié)上沒有過多的闡述，因此企業(yè)在開展可用性研究的時(shí)候還是會(huì)回歸到標(biāo)準(zhǔn)要求來執(zhí)行，但是由于標(biāo)準(zhǔn)版本上的差異，已經(jīng)標(biāo)準(zhǔn)本身跟指導(dǎo)原則上的差異，導(dǎo)致大家對(duì)到底該按照什么要求去執(zhí)行有點(diǎn)迷惑。

好吧，今天咱們就來梳理一下這個(gè)可用性工程標(biāo)準(zhǔn)的流程到底有多大差異，差異中尋找平衡點(diǎn)來同時(shí)滿足指導(dǎo)原則和標(biāo)準(zhǔn)。

先理解一下什么使用的多種方式：

試驗(yàn)機(jī)

可以看出所謂的可用性工程其實(shí)研究的是正常使用下的使用錯(cuò)誤和可合理預(yù)見下的使用中非正常使用。

使用錯(cuò)誤和可合理預(yù)見的非正常使用通過設(shè)備的用戶界面跟使用者產(chǎn)生交互，進(jìn)而設(shè)備產(chǎn)生非預(yù)期的反應(yīng)，由此可能產(chǎn)生危險(xiǎn)或危險(xiǎn)情況。

試驗(yàn)機(jī)

危險(xiǎn)和危險(xiǎn)情況，那就是我們熟悉的風(fēng)險(xiǎn)管理過程的主要研究對(duì)象了，將危險(xiǎn)和危險(xiǎn)情況結(jié)合到產(chǎn)品的風(fēng)險(xiǎn)管理過程中去，進(jìn)一步分析風(fēng)險(xiǎn)并控制風(fēng)險(xiǎn)，這就是可用性的設(shè)計(jì)和實(shí)施。

試驗(yàn)機(jī)

風(fēng)險(xiǎn)管控措施實(shí)施后，到底能不能降低使用錯(cuò)誤或者可合理預(yù)見的非正常使用，進(jìn)而保證設(shè)備的有效性和效率，那就需要有總結(jié)性測(cè)試來確認(rèn)。測(cè)試完了還需要來看是否有新的使用錯(cuò)誤或危險(xiǎn)和危險(xiǎn)情況產(chǎn)生，是否需要進(jìn)一步控制或揭露。

大體的可用性過程就是這樣，廢話不多說了，直接上今天的主題，這四個(gè)版本的標(biāo)準(zhǔn)的差異：

YY/T1474-2016 (IEC 62366:2007 IDT)	IEC 62366:2007+A1:2014	IEC 62366-1:2015	Gap Analysis	IEC 62366-1:2015+A1:2020
4 * Principles		4 * Principles
4.1 General requirements		4.1 General requirements
4.1.1 * USABILITY ENGINEERING PROCESS	Same	4.1.1 USABILITY ENGINEERING PROCESS	Additional 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 RISK	Same	4.1.2 Risk control as it relates to USER interface design	Define 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 SAFETY	Same	4.1.3 Information for SAFETY as it relates to USABILITY	Detail 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 FILE	Same	4.2 USABILITY ENGINEERING FILE	Same	Same
4.3 Scaling of the USABILITY ENGINEERING effort	Same	4.3 Tailoring of the USABILITY ENGINEERING effort	The 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.	Same	5.1 * Prepare USE SPECIFICATION	Simialr, “ intended conditions of use” was replaced by "USE ENVIRONMENT" and Application spec was replaced by USE SPEIFICATION.	Wording change.
5.2 * Frequently used functions	Same	N/A	No such requirement.
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY
5.3.1 Identification of characteristics related to SAFETY	Same User profiles+Frequently used functions	5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS	Identify 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 SITUATIONS	Same	5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS	The 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 SCENARIOS	HAZARD-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 EVALUATION	HAZARD-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 FUNCTIONS	Same	N/A
5.5 * USABILITY SPECIFICATION	Same	5.6 * Establish USER INTERFACE SPECIFICATION	The 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 plan	Same	5.7 * Establish USER INTERFACE EVALUATION plan
		5.7.1 General	More detail about the plan elements.	Should consider the USER GROUPS are intended to be included in the test;
		5.7.2 FORMATIVE EVALUATION planning	FORMATIVE 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 planning	a) 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 implementation	Same	5.8 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 VERIFICATION	Same	N/A	It is same as the FORMATIVE EVALUATION
5.9 * USABILITY VALIDATION	Same	5.9 Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE	Testing: 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 PROVENANCE	Refer to Annex C	Same
6 * ACCOMPANYING DOCUMENT	Same		Combined it to above process
7 * Training and materials for training	Same		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 General	C.1 General	Same	Same
	K.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN PROVENANCE	C.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN PROVENANCE
	K.2.1 * Application specification	C.2.1 * USE SPECIFICATION	Simialr, Application spec was replaced by USE SPEIFICATION.	Same
	K.2.2 PRIMARY OPERATING FUNCTIONS	N/A	POF refer to particular standard	Same
	K.2.3 * Review of post-production information	C.2.2 * Review of POST-PRODUCTION information	Same	Same
	K.2.4 HAZARDS AND HAZARDOUS SITUATIONS caused by USABILITY problems	C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY	delete POF	Same
	K.2.5 RISK CONTROL	C.2.4 RISK CONTROL	Same	Same
	K.2.6 RESIDUAL RISK evaluation	C.2.5 RESIDUAL RISK evaluation	Same	Same
	K.2.7 ACCOMPANYING DOCUMENT	N/A	Combined it to above process

Summary	New 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 EVALUATION	Refer to the latest revsion of ISO 14971 and add more requiements about the summative testing, such as the user group and use difficulty.

來源：包總