AAMI TIR57

Technical Information Report: Principles for medical device security-Risk management

: AAMI

: 2220000409766

: true

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$378.00
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Publication Date: 01/01/2016 - Complete Document

Description :

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. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.

Document Type : Complete Document

Language : English

Page Count : 84

Publication Date : 01/01/2016

Revision : 16

Status : Current

Title : Technical Information Report: Principles for medical device security-Risk management