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Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05)
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| 적용범위 | Preface This is the first edition of CAN/CSA-CEI/IEC 62304, Medical device software - Software life cycle processes, which is an adoption without modification of the identically titled CEI/IEC (Commission ?lectrotechnique Internationale/International Electrotechnical Commission) Standard 62304 (first edition, 2006-05). For brevity, this Standard will be referred to as "CAN/CSA-CEI/IEC 62304" throughout.? Scope 1.1 Purpose This Standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.? 1.2 Field of application? This Standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.? This Standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.? This Standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.? 1.3 Relationship to other standards? This MEDICAL DEVICE SOFTWARE life cycle standard is to be used together with other appropriate standards when developing a MEDICAL DEVICE. Annex C shows the relationship between this standard and other relevant standards.? 1.4 Compliance? Compliance with this standard is defined as implementing all of the PROCESSES, ACTIVITIES, and TASKS identified in this standard in accordance with the software safety class.? NOTE: The software safety classes assigned to each requirement are identified in the normative text following the requirement.? Compliance is determined by inspection of all documentation required by this standard including the RISK MANAGEMENT FILE, and assessment of the PROCESSES, ACTIVITIES and TASKS required for the software safety class. See Annex D.? NOTE 1: This assessment could be carried out by internal or external audit.? NOTE 2: Although the specified PROCESSES, ACTIVITIES, and TASKS are performed, flexibility exists in the methods of implementing these PROCESSES and performing these ACTIVITIES and TASKS.? NOTE 3: Where any requirements contain "as appropriate" and were not performed, documentation for the justification is necessary for this assessment.? NOTE 4: The term "conformance" is used in ISO/IEC 12207 where the term "compliance" is used in this standard.? ---------------------------------------------------------------------------------- Pr?face? Ce document constitue la premi?re ?dition de la CAN/CSA-CEI/IEC 62304, Logiciels de dispositifs m?dicaux - Processus du cycle de vie du logiciel. Il s'agit de l'adoption, sans modification, de la norme CEI/IEC (Commission ?lectrotechnique Internationale/International Electrotechnical Commission) 62304 (premi?re ?dition, 2006-05) qui porte le m?me titre. Par souci de bri?vet?, tout au long de ce document, il sera appel? ?CAN/CSA-CEI/IEC 62304?.? Domaine d'application 1.1 Objet La pr?sente norme d?finit les exigences du cycle de vie des LOGICIELS DE DISPOSITIFS M?DICAUX. L'ensemble des PROCESSUS, ACTIVIT?S et T?CHES d?crit dans la pr?sente norme constitue un cadre commun pour les PROCESSUS du cycle de vie des LOGICIELS DE DISPOSITIFS M?DICAUX.? 1.2 Domaine d'application? La pr?sente norme s'applique au d?veloppement et ? la maintenance des LOGICIELS DE DISPOSITIFS M?DICAUX.? La pr?sente norme s'applique au d?veloppement et ? la maintenance des LOGICIELS DE DISPOSITIFS M?DICAUX lorsque le logiciel est un DISPOSITIF M?DICAL ou lorsque le logiciel est incorpor? ou fait partie int?grante du DISPOSITIF M?DICAL final.? La pr?sente norme ne couvre pas la validation et la mise sur le march? du DISPOSITIF M?DICAL, m?me lorsque le DISPOSITIF M?DICAL est int?gralement constitu? du logiciel.? 1.3 Relations avec d'autres normes? La pr?sente norme couvrant le cycle de vie des LOGICIELS DE DISPOSITIFS M?DICAUX doit ?tre utilis?e conjointement ? d'autres normes pertinentes pour le d?veloppement d'un DISPOSITIF M?DICAL. L'Annexe C pr?sente les relations existant entre la pr?sente norme et d'autres normes pertinentes.? 1.4 Conformit?? La conformit? ? la pr?sente norme est d?finie comme la mise en oeuvre de tous les PROCESSUS, ACTIVIT?S et T?CHES identifi?s dans la pr?sente norme en fonction de la classe de s?curit?.? NOTE: Les classes de s?curit? du logiciel assign?es ? chaque exigence sont identifi?es dans le texte normatif suivant l'exigence.? La conformit? est d?termin?e par inspection de toute documentation exig?e par la pr?sente norme y compris le DOSSIER DE GESTION DES RISQUES et l'?valuation des PROCESSUS, ACTIVIT?S et T?CHES requis pour la classe de S?CURIT? du logiciel. Voir l'Annexe D.? NOTE 1: Cette ?valuation peut ?tre effectu?e par audit interne ou externe.? NOTE 2: M?me lorsque les PROCESSUS, ACTIVIT?S et T?CHES sont effectivement r?alis?s, il existe une certaine flexibilit? dans les m?thodes de mise en oeuvre de ces PROCESSUS et d'ex?cution de ces ACTIVIT?S et T?CHEs.? NOTE 3: Lorsqu'une ?ventuelle exigence comporte la mention ?le cas ?ch?ant? ou ?si n?cessaire? et qu'elle n'est pas r?alis?e, une justification ?crite est n?cessaire pour cette ?valuation.? NOTE 4: Dans la version anglaise de l'ISO/CEI 12207 le terme ?conformance? est utilis? pour ?conformit??, alors que dans la version anglaise de la pr?sente norme, on utilise le terme ?compliance?. ? |
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| 페이지수 | 185 |
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| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA CEI/IEC 62304:14 (R2024) | Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05) | 2014-01-01 | 표준 |
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