Standard for medical device security—Security risk management for device manufacturers

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-21-2022

Publisher

Association for the Advancement of Medical Instrumentation

This document provides requirements and guidance when addressing design, production and post-production security risk management for medical devices within the risk management framework defined by ISO 14971.

DocumentType	Standard
ISBN	978-1-57020-862-1
Pages	61
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current

ISO/IEC/IEEE 15288:2015	Systems and software engineering — System life cycle processes
ISO/TR 22100-4:2018	Safety of machinery Relationship with ISO 12100 Part 4: Guidance to machinery manufacturers for consideration of related IT-security (cyber security) aspects