ANSI/AAMI SW96:2023
Current
The latest, up-to-date edition.
Standard for medical device security—Security risk management for device manufacturers
English
21-12-2022
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 |
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