AAMI TIR32 : 2004 : R2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
Hardcopy , PDF
01-11-2017
English
01-01-2016
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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Withdrawn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 |
| 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 |
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