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AAMI 14708 5 2010 RA 2015

AAMI 14708 5 2010 RA 2015

$128.19

ANSI/AAMI/ ISO 14708-5: 2010/(R)2015 – Implants for surgery-Active implantable medical devices-Part 5: Circulatory support devices

Published By Publication Date Number of Pages
AAMI 2010 62
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Specifies requirements for safety and performance of active implantable circulatory support devices. Excluded from this scope are intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyplasty. This standard specifies type tests, animal studies and clinical evaluation requirements that are to be carried out to show compliance with this standard

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 14708-5:2010/(R)2015, Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents
7 Glossary of equivalent standards
9 Committee representation
10 Background of ANSI/AAMI adoption of ISO 14708-5:2010
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
18 4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
19 6 Requirements for particular active implantable medical devices
6.101 Intended clinical use/indications
6.102 System description
6.102.1 General
6.102.2 Principle of operation
6.102.3 Design consideration
6.102.4 System configuration
6.102.5 System performance and operating limits
6.103 Design analysis
20 6.104 Risk analysis
6.105 Human factors
6.106 In vitro design evaluation and system performance testing
6.106.1 Objective
6.106.2 Initial design evaluation of the pump system
6.106.2.1 Pump performance test
6.106.2.2 Fluid dynamic analysis
21 6.106.2.3 Vibration measurement
6.106.2.4 Cavitation observation
6.106.3 System characterization
6.106.3.1 General
6.106.3.2 Test set-up
6.106.3.3 Test articles
6.106.3.3.1 General
22 6.106.3.3.2 Substitution of device components
6.106.3.4 Test equipment
6.106.3.4.1 General
6.106.3.4.2 Mock circulatory loop
6.106.3.4.3 Physiological limits
6.106.3.4.4 Blood analogue fluid
6.106.3.4.5 Test measurement equipment
6.106.3.4.5.1 Transducers
6.106.3.4.5.2 Use of the device system as test measurement equipment
23 6.106.3.4.5.3 Data handling
6.106.3.5 Test conditions
6.106.3.6 Parameters to be measured
6.106.3.7 Data analysis
6.106.3.8 “Worst case” operating conditions
24 6.106.4 System component testing
6.106.4.1 Control and drive units
6.106.4.1.1 External units
6.106.4.1.2 Implantable controllers and drivers
6.106.4.2 Programming and monitoring units
6.106.4.3 Power supplies
25 6.106.4.4 Batteries
6.106.4.5 Connections and connectors
6.106.4.5.1 Electrical connection
6.106.4.5.2 Lines
6.106.4.5.3 Vascular grafts, cannulae, blood conduits, atrial and apical cuffs
26 6.106.4.6 Artificial/prosthetic valves
6.106.4.7 Transcutaneous energy transmission systems
6.107 Electromagnetic compatibility
27 6.108 Materials qualification
6.109 Biocompatibility
6.110 Environmental testing
28 6.111 In vivo evaluation
6.111.1 Objective
6.111.1.1 General
6.111.1.2 Safety
6.111.1.3 Performance
6.111.2 Definition of success or failure
6.111.3 Test articles
6.111.4 Test system
6.111.4.1 Test animals
6.111.4.1.1 General
29 6.111.4.1.2 Choice of animal model
6.111.4.1.3 Sample size and implant duration
6.111.4.2 Control
6.111.5 Test equipment
6.111.6 Preoperative animal care
6.111.7 Implant procedure
6.111.8 Special instructions for early termination
30 6.111.9 Post-operative care
6.111.10 Anticoagulation
6.111.11 Adverse events
6.111.12 System performance
6.111.13 Measurement of physiological parameters
6.111.14 Blood measurements
6.111.14.1 Timing
6.111.14.2 Blood parameters
6.111.15 Necropsy and device retrieval
31 6.111.16 Macroscopic examination
6.111.17 Histological examination
6.111.18 Explanted device analysis
6.111.19 Data analysis
6.112 Reliability
33 6.113 Clinical evaluation
7 General arrangement of the packaging
8 General markings for active implantable medical devices
8.101 General
9 Markings on the sales packaging
34 10 Construction of the sales packaging
11 Markings on the sterile packaging
12 Construction of the non-reusable packaging
35 13 Markings on the active implantable medical device
14 Protection from unintentional biological effects caused by the active implantable medical device
15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
16 Protection from harm to the patient caused by electricity
17 Protection from harm to the patient caused by heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the device
19.1 Line power supplies
36 19.2 Risk analysis
37 19.3 Software verification and validation
20 Protection of the device from damage caused by external defibrillators
21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
23 Protection of the active implantable medical device from mechanical forces
24 Protection of the active implantable medical device from damage caused by electrostatic discharge
25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from damage caused by temperature changes
38 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
28 Accompanying documentation
28.1 Instructions for use
40 Annex AA Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this part of ISO 14708
50 Annex BB Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA
52 Annex CC Rationale
CC.1 General
53 CC.2 Notes on specific clauses and subclauses
6.106.4.6 Artificial/prosthetic valves
6.111.2 An example of a definition of success
54 6.111.6 Preoperative animal care
6.111.9 Post-operative care
55 6.111.11 Reference for adverse event definitions
6.111.13 Measurement of physiological parameters
6.111.14.2 Blood parameters
56 6.112 r) One example of foreseeable physiological conditions for a left ventricular assist device
57 Annex DD In vitro test
DD.1 Flow visualization
DD.1.1 Test methods
DD.1.2 Examples of test variables
DD.2 Example of the test conditions used to characterize the system
58 DD.3 Examples of measurement for volume displacement and rotary devices
DD.3.1 Volume displacement devices
59 DD.3.2 Rotary devices
DD.4 Application of computational fluid dynamic (CFD) analysis
DD.4.1 General
DD.4.2 Design and performance to be evaluated with CFD analysis
60 DD.4.3 Procedures governing analysed quantities
61 Bibliography
AAMI 14708 5 2010 RA 2015
$128.19