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Medical device software - Software life cycle processes
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 62304:2006+A1:2015 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. 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. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 170 |
| Edition | 1.1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 62304:2006/AMD1:2015 | Amendment 1 - Medical device software - Software life cycle processes | 2015-06-26 | 표준 |
| 2 | IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes | 2015-06-26 | 표준 |
| 3 | IEC 62304:2006 | Medical device software - Software life cycle processes | 2006-05-09 | 표준 |
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