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Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (no
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| 적용범위 | Preface This is the first edition of CAN/CSA-IEC 62366-1, Medical devices ? Part 1: Application of usability engineering to medical devices, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 62366-1 (first edition, 2015-02). It replaces CAN/CSA-IEC 62366:14 (adopted IEC 62366:2007). For brevity, this Standard will be referred to as "CAN/CSA-IEC 62366-1" throughout. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety related aspects of medical device user interfaces. 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 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. NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to direct physical HAZARDS or loss or degradation of clinical functionality. NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY. 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. NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance. -------------------------------------------------------------------------------------------------------------------------------- Pr?face? Ce document constitue la premi?re ?dition de la CAN/CSA-IEC 62366-1, Dispositifs m?dicaux ? Partie 1 : Application de l’ing?nierie de l’aptitude ? l’utilisation aux dispositifs m?dicaux. Il s’agit de l’adoption, sans modification, de la norme IEC (Commission ?lectrotechnique Internationale) 62366-1 (premi?re ?dition, 2015-02) qui porte le m?me titre. Cette norme remplace CAN/CSA-IEC 62366:14 (norme IEC 62366:2007 adopt?e). Par souci de bri?vet?, tout au long de ce document, il sera appel? ?CAN/CSA-IEC 62366-1?. La premi?re ?dition de l’IEC 62366-1, ainsi que la premi?re ?dition de l’IEC 62366-2, annule et remplace la premi?re ?dition de l’IEC 62366 parue en 2007 et son Amendement 1 (2014). La Partie 1 a ?t? mise ? jour afin d’inclure des concepts contemporains d’ing?nierie de l’aptitude ? l’utilisation, tout en rationalisant le processus. Elle renforce aussi les liens avec l’ISO 14971:2007 et les m?thodes connexes de gestion des risques appliqu?es aux aspects relatifs ? la s?curit? des interfaces utilisateur des dispositifs m?dicaux. La Partie 2 contient des informations didactiques pour aider les fabricants ? se conformer ? la Partie 1 et fournit des descriptions plus d?taill?es des m?thodes d’ing?nierie de l’aptitude ? l’utilisation qui peuvent ?tre appliqu?es d’une fa?on plus g?n?rale aux dispositifs m?dicaux et qui vont au-del? des aspects relatifs ? la s?curit? des interfaces utilisateur des dispositifs m?dicaux. Domaine d'application La pr?sente partie de l'IEC 62366 sp?cifie un PROCESSUS permettant ? un FABRICANT d’analyser, de sp?cifier, de d?velopper et d'?valuer l'APTITUDE A L’UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L’APTITUDE A L'UTILISATION (INGENIERIE DES FACTEURS HUMAINS) permet au FABRICANT d'?valuer et de r?duire les RISQUES associ?s ? une UTILISATION CORRECTE et ? des ERREURS D’UTILISATION, c’est-?-dire une UTILISATION NORMALE. Il peut ?tre utilis? pour identifier les RISQUES associ?s ? une UTILISATION ANORMALE mais ne les ?value pas et ne les r?duit pas. NOTE 1 La SECURITE est d?finie comme l'absence de RISQUE inacceptable. Le RISQUE inacceptable peut provenir d'une ERREUR D'UTILISATION, ce qui peut mener ? une exposition ? des PHENOMENES DANGEREUX physiques directs ou ? une perte ou une d?gradation de la fonctionnalit? clinique. NOTE 2 Des lignes directrices relatives ? l'application de l'INGENIERIE DE L’APTITUDE A L'UTILISATION aux DISPOSITIFS MEDICAUX sont disponibles dans l'IEC 62366-22, qui traite non seulement de la SECURITE mais aussi des aspects de l’APTITUDE A L'UTILISATION non relatifs ? la SECURITE. Si le PROCESSUS D'INGENIERIE DE L’APTITUDE A L'UTILISATION d?taill? dans la pr?sente norme internationale a ?t? satisfait, l'APTITUDE A L'UTILISATION d'un DISPOSITIF MEDICAL concernant la SECURITE est alors pr?sum?e acceptable, sauf s'il existe une PREUVE TANGIBLE du contraire. NOTE 3 Une PREUVE TANGIBLE de ce type peut ensuite provenir de la surveillance POSTPRODUCTION. ? |
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| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED) | Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, edition 1:2015 consolidated with amendment 1:2020) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation a | 2022-01-01 | 표준 |
| 2 | IEC 62366-1:2015/AMD1:2020 | Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 3 | IEC 62366-1:2015+AMD1:2020 CSV | Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 4 | IEC 62366-1:2015/COR1:2016 | Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2016-07-14 | 표준 |
| 5 | IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices | 2015-02-24 | 표준 |
| 6 | CSA IEC 62366-1:15 (R2020) | Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (no | 2015-01-01 | 표준 |
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices 상세보기
IEC TR 62366-2:2016 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices 상세보기
IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices 상세보기
IEC 62366-1:2015/COR1:2016 - Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
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