AAMI TIR38 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 SAFETY ASSURANCE CASE REPORT GUIDANCE
Hardcopy , PDF
20-02-2019
English
01-01-2015
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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Superseded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 | |
| Supersedes |
| 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 |
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