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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
Hardcopy , PDF
08-03-2010
English
01-01-2000
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Superseded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 |
ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
ASTM D 4169 : 2016 : REDLINE | Standard Practice for Performance Testing of Shipping Containers and Systems |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 60801-1:1984 | Electromagnetic compatibility for industrial-process measurement and control equipment. Part 1: General introduction |
AAMI VP20 : 2ED 94 | CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES |
IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
AAMI ISO 15223 : 2000 AMD 2 2004 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING, AND INFORMATION TO BE SUPPLIED |
AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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.