Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

AAMI TIR32 :2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
Available format(s)

Hardcopy , PDF

Superseded date

11-01-2017

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
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Superseded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

View more information
Hardcopy - English
PDF - English - DRM

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us