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ISO/IEC Guide 63:2012

Guide to the development and inclusion of safety aspects in International Standards for medical devices
10. 1. 2012.
95.99   Povučen   12. 8. 2019.

Опште информације

95.99     12. 8. 2019.

ISO/IEC

ISO/TMBG

Uputstvo

11.020.01  

engleski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO/IEC Guide 63:1999

TRENUTNO

POVUČEN
ISO/IEC Guide 63:2012
95.99 Povučen
12. 8. 2019.

REVIDIRAN OD

OBJAVLJEN
ISO/IEC Guide 63:2019