AAMI TIR32 : 2004 : R2016

Name: AAMI TIR32 : 2004 : R2016
Brand: AAMI
Price: 102.68 GBP

Withdrawn

MEDICAL DEVICE SOFTWARE RISK MANAGEMENT

Available format(s)

Hardcopy , PDF

Withdrawn date

01-11-2017

Language(s)

English

Published date

01-01-2016

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 References
3 Definitions
4 Perspective 1: Basic concepts of medical device software
  risk management
5 Perspective 2: Software considerations in medical device
  risk management
6 Perspective 3: Software risk management within a software
  life cycle
7 Perspective 4: Soft factors in software risk management
Annexes
A - Direct causes sample table
B - Indirect causes and risk control measures table
    (failures due to unpredictable behaviors)

Describes a framework within which experience, insight, and judgment are applied systematically to reduce medical device risks.

Committee	SW
DocumentType	Standard
Pages	77
ProductNote	Reconfirmed 2016
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Withdrawn
Supersedes	AAMI TIR32 :2004

ISO/IEC 15026:1998	Information technology System and software integrity levels
IEEE 610 : 1991	COMPUTER DICTIONARY - A COMPILATION OF IEEE STANDARD COMPUTER GLOSSARIES
IEC 61508-3:2010	Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
IEC TR 60513:1994	Fundamental aspects of safety standards for medical electrical equipment
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO/IEC 12207:2008	Systems and software engineering Software life cycle processes
AAMI SW68 : 1ED 2001	MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9000-3:1997	Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software