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自《醫(yī)療器械可用性工程注冊審查指導(dǎo)原則》 發(fā)布以來，可用性工程的熱度一直不減，在各個三方機構(gòu)和咨詢公司的推波助瀾下，外加GB 9706.1三版實施進入正常化下，可用性的相關(guān)話題就越發(fā)顯得熱火。對于指導(dǎo)原則有太多解讀了，就不去抽這個熱鬧了，今天來聊聊后臺很多小伙伴私信我的一個普遍問題， 就是到底該如何看到可用性的標準。
有這個問題的原因在于目前國內(nèi)現(xiàn)行有效的可用性工程標準是YY/T 1474-2016 醫(yī)療器械可用性工程對醫(yī)療器械的應(yīng)用, 指導(dǎo)原則里也引用了這個標準，但是YY/T 1474-2016 等同轉(zhuǎn)換于IEC 62366:2007，同時指導(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準，對于整個可用性過程的展開在細節(jié)上沒有過多的闡述，因此企業(yè)在開展可用性研究的時候還是會回歸到標準要求來執(zhí)行，但是由于標準版本上的差異，已經(jīng)標準本身跟指導(dǎo)原則上的差異，導(dǎo)致大家對到底該按照什么要求去執(zhí)行有點迷惑。
好吧，今天咱們就來梳理一下這個可用性工程標準的流程到底有多大差異，差異中尋找平衡點來同時滿足指導(dǎo)原則和標準。
先理解一下什么使用的多種方式：
可以看出所謂的可用性工程其實研究的是正常使用下的使用錯誤和可合理預(yù)見下的使用中非正常使用。
使用錯誤和可合理預(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，進而設(shè)備產(chǎn)生非預(yù)期的反應(yīng)，由此可能產(chǎn)生危險或危險情況。
危險和危險情況，那就是我們熟悉的風(fēng)險管理過程的主要研究對象了，將危險和危險情況結(jié)合到產(chǎn)品的風(fēng)險管理過程中去，進一步分析風(fēng)險并控制風(fēng)險， 這就是可用性的設(shè)計和實施。
風(fēng)險管控措施實施后，到底能不能降低使用錯誤或者可合理預(yù)見的非正常使用，進而保證設(shè)備的有效性和效率，那就需要有總結(jié)性測試來確認。測試完了還需要來看是否有新的使用錯誤或危險和危險情況產(chǎn)生，是否需要進一步控制或揭露。
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，這四個版本的標準的差異：
| 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. |
還是老規(guī)矩，需要具體excel的，可以后臺留言或加微信索要。