Principles for medical device security—Risk management

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2023

Publisher

Association for the Advancement of Medical Instrumentation

This Technical Information Report (TIR) provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971.

DocumentType	Standard
ISBN	978-1-57020-612-2
Pages	84
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI TIR57:2016(R2019)

IEC TR 80001-2-8:2016	Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
ISO/IEC 30111:2019	Information technology Security techniques Vulnerability handling processes
IEC TR 80001-2-2:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO/IEC 29147:2018	Information technology — Security techniques — Vulnerability disclosure