SK ISO/IEC Guide 63:2016
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Status: Published
Gjuha: English Faqe: 23 Publikuar: 2016-07-20 Regjistri Kombëtar: Botim: |
Standardet ndërkombëtare që kanë lidhje
This standard is identical to:
ISO/IEC GUIDE 63 |
Çmim: 25 €
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Titulli Shqip
Udhëzim për zhvillimin dhe përfshirjen e aspekteve të sigurisë në standardet ndërkombëtare për pajisjet mjekësore
Titulli Anglisht
Guide to the development and inclusion of safety aspects in International Standards for medical devices
Scope Shqip
Asnjë informacion i shtuar.
Scope Anglisht
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.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.