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: \u2014 ventricular assist devices (VAD), left or right heart support; \u2014 total artificial hearts (TAH); \u2014 biventricular assist devices (biVAD); \u2014 percutaneous assist devices; \u2014 paediatric assist devices.<\/p>\n
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| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.4 Risk analysis <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6.5 Human factors 6.6 In vitro design evaluation and system performance testing 6.6.1 Objective 6.6.2 System characterization <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6.6.3 Subsystem component testing <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 6.7 Electromagnetic compatibility 6.8 Materials qualification <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 6.9 Biocompatibility 6.10 Dynamic haemolysis 6.11 Environmental testing 6.12 In vivo evaluation 6.12.1 Objective <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 6.12.2 Definition of success or failure 6.12.3 Test articles 6.12.4 Test system <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 6.12.17 Macroscopic examination 6.12.18 Histological examination 6.12.19 Explanted device analysis 6.12.20 Data analysis 6.13 Reliability <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.14 Clinical evaluation 7 General arrangement of the packaging <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 27.6 Protection from proximity fields due to RF wireless communications equipment 28 Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Annex A (informative) Relationship between the fundamental principles in ISO\/TR 14283 and the clauses of this document <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Annex B (informative) Rationale <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Annex C (informative) Pre-clinical in vitro\/in silico evaluation <\/td>\n<\/tr>\n | ||||||
| 75<\/td>\n | Annex D (informative) Active implantable medical device hazards, associated failure modes, and evaluation methods <\/td>\n<\/tr>\n | ||||||
| 77<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Implants for surgery. Active implantable medical devices – Circulatory support devices<\/b><\/p>\n |