Name: AAMI TIR38 : 2015
Brand: AAMI
Price: 229.00 USD

AAMI TIR38 : 2015

Superseded

View Superseded by

MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE

Available format(s)

Hardcopy , PDF

Superseded date

02-20-2019

Language(s)

English

Published date

01-01-2015

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Purpose
2 Scope
3 Relationship to other standards
4 Terms and definitions
5 Regulatory context
6 Safety case model for a generic medical device
7 Generation of system and sub-system hazards
8 Confidence case
9 Challenge
10 Common mistakes to avoid
11 Developing a safety case for an existing device
12 Safety cases and risk management
13 Lifecycle management
14 Maintaining the safety case
15 Styles of safety case notation
Annex A (informative) - Assurance cases and evidence
        of substantial equivalence
Annex B (informative) - Safety case model examples
Annex C (informative) - AdvaMed Infusion Pump
        Assurance Case (IPAC) Template
Annex D (informative) - Tool selection considerations
Annex E (informative) - Developing a safety case for
        an existing product
Annex F (informative) - Lessons learned regarding
        safety cases
Bibliography

Gives guidance on the development of Safety Cases for the design of a medical device.

DocumentType	Standard
Pages	65
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	AAMI TIR38:2019
Supersedes	AAMI TIR38 : 2014

IEC TR 80002-1:2009	Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
NASA SP 3421 : 2011	PROBABILISTIC RISK ASSESSMENT PROCEDURES GUIDE FOR NASA MANAGERS AND PRACTITIONERS
ISO/IEC TR 15026-1:2010	Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
IEC 62304:2006+AMD1:2015 CSV	Medical device software - Software life cycle processes
ASTM F 2761 : 2009 : R2013	Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
ISO/IEC 15026-2:2011	Systems and software engineering — Systems and software assurance — Part 2: Assurance case
DEFSTAN 00-56(PT1)/5(2014) : 2014	SAFETY MANAGEMENT REQUIREMENTS FOR DEFENCE SYSTEMS - PART 1: REQUIREMENTS AND GUIDANCE
ISO 14971:2007	Medical devices Application of risk management to medical devices