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BS EN ISO 14708-5:2022

BS EN ISO 14708-5:2022

$215.11

Implants for surgery. Active implantable medical devices – Circulatory support devices

Published By Publication Date Number of Pages
BSI 2022 80
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This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: ā€” ventricular assist devices (VAD), left or right heart support; ā€” total artificial hearts (TAH); ā€” biventricular assist devices (biVAD); ā€” percutaneous assist devices; ā€” paediatric assist devices.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
15 4 Symbols and abbreviations
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
5.2 General requirements for software
5.3 Usability of non-implantable parts
16 5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
5.6 Misconnection of parts of the active implantable medical device
5.7 Wireless coexistence and wireless quality of service
6 Requirements for particular active implantable medical devices
6.1 Intended clinical use/indications
6.2 System description
6.2.1 General
18 6.2.2 System configuration
6.2.3 System performance and operating limits
6.3 Design analysis
6.3.1 General
6.3.2 Human factors analysis
19 6.4 Risk analysis
20 6.5 Human factors
6.6 In vitro design evaluation and system performance testing
6.6.1 Objective
6.6.2 System characterization
23 6.6.3 Subsystem component testing
27 6.7 Electromagnetic compatibility
6.8 Materials qualification
28 6.9 Biocompatibility
6.10 Dynamic haemolysis
6.11 Environmental testing
6.12 In vivo evaluation
6.12.1 Objective
29 6.12.2 Definition of success or failure
6.12.3 Test articles
6.12.4 Test system
30 6.12.5 Control
6.12.6 Test equipment
6.12.7 Preoperative animal care
6.12.8 Implant procedure
6.12.9 Special instructions for early termination
31 6.12.10 Postoperative care
6.12.11 Anticoagulation
6.12.12 Adverse events
6.12.13 System performance
6.12.14 Measurement of physiological parameters
6.12.15 Clinical pathology
6.12.16 Necropsy and device retrieval
32 6.12.17 Macroscopic examination
6.12.18 Histological examination
6.12.19 Explanted device analysis
6.12.20 Data analysis
6.13 Reliability
33 6.14 Clinical evaluation
7 General arrangement of the packaging
34 8 General markings for active implantable medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile pack
35 12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects being caused by the active implantable medical device
36 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
17.1 Protection from harm to the patient caused by heat
17.2 Active implantable medical device intended to supply heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the active implantable medical device
37 20 Protection of the active implantable medical device from damage caused by external defibrillators
21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
38 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
39 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
27.1 General
27.2 Test conditions
27.2.1 Acceptance criteria
27.2.2 Test configuration and setup
40 27.2.3 Operating functions, modes, and settings
27.2.4 Patient physiological simulation
27.2.5 Immunity test levels
27.3 Risk management file and test report file documentation
41 27.4 Protection from static magnetic fields of flux density up to 50 mT
27.5 Protection from AC magnetic fields in the range of 1 kHz to 140 kHz
42 27.6 Protection from proximity fields due to RF wireless communications equipment
28 Accompanying documentation
46 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this document
65 Annex B (informative) Rationale
71 Annex C (informative) Pre-clinical in vitro/in silico evaluation
75 Annex D (informative) Active implantable medical device hazards, associated failure modes, and evaluation methods
77 Bibliography

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BS EN ISO 14708-5:2022
$215.11