관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
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분야 | ISO/TMBG : Technical Management Board - groups |
---|---|
적용범위 | This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices. |
국제분류(ICS)코드 |
11.040.01 : 일반 의료장비
01.120 : 표준화. 일반 규칙 |
페이지수 | 26 |
Edition | 3 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices | 2019-08-12 | 표준 |
2 | ISO/IEC GUIDE 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices | 2019-08-12 | 표준 |
3 | ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices | 2012-01-10 | 구판 |
4 | ISO/IEC GUIDE 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices | 2012-01-10 | 구판 |
5 | ISO/IEC GUIDE 63:1999 | Guide to the development and inclusion of safety aspects in International Standards for medical devices | 1999-02-04 | 구판 |
6 | ISO/IEC Guide 63:1999 | Guide to the development and inclusion of safety aspects in International Standards for medical devices | 1999-02-04 | 구판 |
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