ISO/IEC GUIDE 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices

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Guide to the development and inclusion of safety aspects in International Standards for medical devices

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분야
적용범위	ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability. ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
국제분류(ICS)코드	11.020 : 의학 일반 01.120 : 표준화. 일반 규칙 11.020.01 : 헬스케어 품질 및 환경 경영
페이지수	21
Edition	2.0

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