AAMI TIR32 :2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
Hardcopy , PDF
11-01-2017
English
01-01-2016
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 |
76
|
| ProductNote |
Reconfirmed 2004
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| 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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