The electronic version of this Guide can be downloaded from the ISO/IEC Guides web page.
Resumen
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.
Ciclo de vida
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Anteriormente
RetiradaISO/IEC Guide 63:2012
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Ahora
PublicadoISO/IEC Guide 63:2019
Las normas se revisan cada 5 años
Etapa: 90.60 (En proceso de revisión)