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ANSI/AAMI SW96:2023

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

21-12-2022

€246.76
Excluding VAT

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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