AAMI TIR26 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
English
16-10-2000
08-03-2010
Committee representation
Foreword
Introduction
1 Scope
2 References
3 Definitions and abbreviations
4 Intended clinical use and indications
5 System description
5.1 Principle of operation
5.2 Design consideration
5.3 System configuration
5.4 System performance and operating limits
5.5 Design analysis
5.6 Risk analysis
5.7 Human factors
5.7.1 General
5.7.2 Specific human factors considerations
6 In vitro design evaluation
6.1 In vitro test setup
6.2 "Worst-case" operating conditions
6.3 Fluid dynamics
6.4 Software verification and validation
6.5 Electrical qualification
6.5.1 Electromagnetic compatibility
6.5.2 Electrical safety
6.6 Power sources
6.6.1 Transcutaneous energy transmission systems
6.6.2 Batteries
6.7 Mechanical qualification
6.7.1 Connections and connectors
6.7.1.1 Electrical
6.7.1.2 Pneumatic/gas
6.7.1.3 Blood/conduits
6.7.2 Vascular grafts
6.7.3 Valves
6.7.4 Materials qualification
6.8 Biocompatibility
6.9 Environmental testing
7 In vivo design evaluation
7.1 In vivo study plan
7.2 In vivo protocol
7.3 In vivo analysis plan
8 Reliability
9 Clinical trial considerations
10 Labeling
10.1 General
10.2 Instructions for use
10.2.1 General
10.2.2 Contra-indications and associated precautions
10.2.3 Human factors considerations
Annexes
A - Rationale for the development and provisions of this
technical information report
B - Example environmental testing matrix
C - Bibliography
Gives guidelines for gathering data and information to demonstrate the safety and effectiveness of ventricular assist and heart replacement systems for patients with heart dysfunction.
| Committee |
MC
|
| DocumentType |
Standard
|
| Pages |
27
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
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