AAMI CI86 2017
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ANSI/AAMI CI86:2017 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 179 |
This standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combination devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design issues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelatedmedical treatments, and normal use.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI CI86:2017; Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Foreword |
| 11 | 1 Scope |
| 12 | 2 Normative references |
| 14 | 3 Definitions |
| 22 | 4 Units, abbreviations, and symbols 4.1 Units |
| 23 | 4.2 Abbreviations 4.3 Symbols |
| 24 | 5 General requirements for characterizing a cochlear implant system 5.1 General description of device, intended uses, and model designations Figure 1—Example block diagram of device system hardware and software components andconnections/links |
| 25 | 5.2 Specific inventory of system components 5.2.1 Implantable components 5.2.1.1 Receiver–stimulators 5.2.1.2 Electrode systems 5.2.1.3 Connector systems 5.2.1.3.1 Percutaneous connectors 5.2.1.3.2 Implantable system connectors 5.2.2 Non-implantable components 5.2.2.1 Sound processors and body-worn accessories |
| 26 | 5.2.2.2 Non-body-worn accessories and replaceable body-worn components 5.2.2.3 Body-worn and non-body-worn cables 5.2.2.4 Components for system clinical support (e.g., clinical programming pods, clinical mapping software, test materials) 5.2.2.5 Components for surgical support (e.g., insertion tools, templates) 5.2.3 Compatible components 5.3 Wireless technology description |
| 27 | 5.4 System hardware description 5.5 System software, including sound processing strategies |
| 28 | Figure 2—High-level overview block diagram of a simple cochlear implant system Figure 3—Example of a system software architecture diagram for a sound processor |
| 29 | Figure 4—Diagram of a detailed end-to-end signal-path overview block diagram.The |
| 30 | Figure 5—Example of a block diagram of the continuous interleaved sampling (CIS) sound coding strategy |
| 31 | Figure 6—Examples of various mapping functions 5.6 Physical specifications of sound processing hardware |
| 32 | 5.7 Electrode specification and characteristics |
| 33 | 5.8 Features of clinical fitting software 5.9 Stimulation methodology and provisions for safe stimulation 5.9.1 Overview 5.9.2 Stimulation waveforms |
| 34 | 5.9.3 Stimulation circuitry 5.9.4 Provisions for safe stimulation 5.10 Interconnection between implantable and non-implantable parts 5.11 Ancillary functions of the cochlear implant system |
| 35 | 5.12 Microphones for sound processor 5.12.1 Description of the microphones 5.13 Auxiliary inputs to sound processor 5.13.1 General information 5.13.2 Inductive links 5.13.3 Hearing assistive technology (HAT), including FM links and other technologies |
| 36 | 5.13.4 Direct connection features 5.14 Remote controls 5.14.1 Description of the remote control 5.14.2 Electrical properties 5.14.3 Remote control battery 5.14.4 Physical properties |
| 37 | 6 General requirements for implantable parts 6.1 Biocompatibility 6.2 Useful life for design and testing purposes 6.3 Electromagnetic compatibility (EMC) 6.4 Surface features |
| 38 | 6.5 Safety of electrode insertion 6.6 Safety of implantable batteries 6.7 Protection against external electrical hazards for fully implantable systems 6.8 Interconnection of implantable parts |
| 39 | 6.9 Electronic assembly life test 7 General requirements for non-implantable parts 7.1 Biocompatibility 7.2 Protection against external electrical hazards 7.3 Protection against hazards associated with external surfaces |
| 40 | 7.4 External battery safety 7.5 Electromagnetic compatibility (EMC) 7.6 General requirements for software 7.6.1 Life cycle design 7.6.2 Medical device risk management, interoperability, and cybersecurity |
| 41 | 7.6.3 Clinical accessibility to mapping parameters in both clinical and physical units 7.7 Requirements for user accessories and clinical tools 8 System-level inspection, characterization, and measurement 8.1 Measurement of output signal characteristics 8.2 Measurement of the output signal amplitude and stimulus timing parameters |
| 42 | Figure 7—Configuration for measurement of output signal amplitude and impedance 8.2.1 Measurements taken during steady-state operation of the implantable part 8.2.2 Measurements taken during power-up operation of the implantable part |
| 43 | 8.2.3 Measurements taken during power-down operation of the implantable part 8.3 Impedance measurement accuracy 8.4 Inductive link characterization 8.5 Sound processor battery testing |
| 44 | 8.5.1 Typical system operation time on single battery charge 8.5.2 Rechargeable battery fade test |
| 45 | 8.6 Risk-based selection of test sample size 8.6.1 General requirements |
| 47 | Figure 8— General process for determining sample size |
| 48 | 8.6.2 Default levels of ‘sample size category’ – Path 2 8.6.3 Determination of risk ranking using design analysis – Path 3 Table 1—Severity of harm in rank order |
| 49 | Table 2—Occurrence-of-harm definitions and ranking Table 3—Risk ranking* |
| 50 | Table 4—Risk definitions 8.6.4 Determination of the required conforming and confidence proportions – Paths 2 and 3 Table 5—Required conforming and confidence proportions for a given risk level 8.6.5 Selection of analysis method and determination of sample size – Paths 2 and 3 |
| 51 | Table 6—Minimum sample sizes for prescribed levels of conforming and confidence proportions fora binominal test with zero failures 8.7 Design verification tests for system components 8.8 Reporting requirements for validation and verification testing |
| 52 | 9 Implantation support (RESERVED FOR FUTURE VERSIONS) 10 Post-implantation testing, in vivo assessment, and analysis of failed devices 10.1 Functional evaluation of a device in vivo |
| 53 | 10.2 Removal and return of explanted components and analysis report |
| 54 | 10.3 Testing of returned implantable components |
| 55 | 11 Reliability monitoring and reporting |
| 56 | 11.1 General requirements 11.1.1 Analysis and recording of field returns 11.1.2 Audiences for field reliability information 11.1.3 Components for which reliability reporting applies 11.1.3.1 Implantable components 11.1.3.2 Non-implantable components |
| 57 | 11.1.4 Registration of implantable components and notification of their explantation or removal from service 11.1.5 Complementary field data describing the history of the system in the field 11.1.6 Requirements for field assessment of implantable components suspected of failure |
| 58 | 11.2 Specific requirements related to implantable components 11.2.1 Identification and documentation of failed implantable components 11.2.2 Analysis and classification of explanted components 11.2.2.1 General requirement |
| 59 | 11.2.2.2 General process for analysis of explanted components |
| 60 | Figure 9—Minimum procedures for failure analysis of implantable components |
| 61 | Table 7- Classifications of explanted devices |
| 62 | 11.2.2.3 Intake, decontamination and initial functional screening 11.2.2.4 Classification of explanted components and full specification testing |
| 65 | 11.3 Specific requirements related to non-implantable components 11.3.1 Testing of returned non-implantable components |
| 66 | 11.3.2 Identification and categorization of returned non-implantable components Figure 10—Minimum classifications for failure analysis of sound processors 11.4 Requirements for reporting field reliability data to regulatory bodies |
| 67 | 11.4.1 Schedule and method of reporting to regulatory bodies 11.4.2 Implantable components reliability report to regulatory bodies 11.4.2.1 General requirement 11.4.2.2 Analysis of cumulative failure percentage |
| 70 | 11.4.2.3 Pareto analysis of primary root cause of failure mechanisms |
| 71 | 11.4.3 Non-implantable components reliability report to regulatory bodies 11.4.3.1 General requirement 11.4.3.2 Monthly return failure rates for non-implantable components 11.4.3.3 Root cause identification of failures using Pareto analysis |
| 72 | 11.5 Requirements for reporting field reliability data to the public and the clinical community 11.5.1 Schedule and method of reporting to the public and the clinical community 11.5.2 Reliability data for public reporting |
| 73 | Figure 11—Minimum classifications for failure analysis of implantable components for public reporting Figure 12—Minimum classifications for failure analysis of sound processors for public reporting |
| 74 | 12 Information on use, warnings, and hazards 12.1 Specification of product data sheets 12.2 Instructions on proper use of the device by the physician, audiologist, and/or patient 12.2.1 Manufacturer contact information 12.3 Information regarding device and accessory selection 12.4 Information on potential hazards at implantation 12.5 Warnings regarding maintaining proper operating environment |
| 75 | 12.6 Warning of potential damage because of electrical currents from medical treatments 12.7 Warning to avoid ultrasonic exposure of implanted device 12.8 Warning of potential damage by therapeutic ionizing radiation 12.9 Warning that the implantable device is not for reuse 12.10 Information on exceptional environments and constraints on handling the implant 12.11 Warning of precautions for adverse environments |
| 76 | 12.11.1 Warning of environments adverse to the patient 12.11.2 Warning of environments adverse to the device 12.12 Warning to the patient to seek medical advice before entering adverse environment 12.13 Warning of precautions to prevent adverse effects that could be caused by performance changes 12.14 Information about administration of medicinal products |
| 77 | 12.15 Warning regarding tissue damage that could be caused by excessive coil retention forces and the need for clinical monitoring and management 12.16 Warning regarding the magnetic field from headpiece coil causing the reprogramming of magnetic shunts 12.17 Warning of possible side effects during normal use 12.18 Warning of possible choking hazards associated with use of long cables with infants and young children 12.19 Warning of hazards associated with swallowing small parts 12.20 Information regarding access to reliability information for clinicians and public |
| 78 | 12.21 Information regarding the availability of field assessment information for clinicians 12.22 Labeling of ingress protection 12.23 Informational summary of safety and effectiveness data 12.24 Information about immunization of cochlear implant candidates 12.25 Information about MRI safety and immunity claims 12.25.1 Definitions 12.25.2 Applicability of labeling requirements |
| 79 | Table 8—Applicability of MRI labeling requirements 12.25.3 MRI labeling requirements |
| 80 | 12.25.4 Availability of Labeling 13 General arrangement of the packaging system 13.1 Implant in a non-reusable sterile barrier system 13.2 Non-reusable sterile barrier system in protective packaging 13.3 Construction and validation of the packaging system 14 Markings on the packaging system and the cochlear implant device |
| 81 | 14.1 General requirements 14.1.1 Prominent display of warning notices 14.1.2 Device traceability 14.2 Markings on the protective packaging 14.2.1 Markings for radioactivity 14.2.2 Identification of manufacturer 14.2.3 Month, day, and year of manufacture 14.2.4 Use-before date 14.2.5 Description of device |
| 82 | 14.2.6 Intended use of device 14.2.7 Additional identifying description of implantable device 14.2.8 Statement of sterilization (protective packaging) 14.2.9 Declaration of sterilization (accompanying documentation) 14.2.10 Guidelines on device sterilization methods 14.2.11 Identification of accessories 14.2.12 Identification of required connectors or configurations |
| 83 | 14.2.13 Exceptional environmental or handling constraints 14.2.14 Designation of special-use devices 14.2.15 Use of symbols on sales packaging and the sterile barrier system 14.3 Markings on the sterile barrier system 14.3.1 Multiple products in similar sterile barrier systems 14.3.2 Identification of the manufacturer and address of the manufacturing location 14.3.3 Statement of sterilization and identification of sterilization method |
| 84 | 14.3.4 STERILE symbol 14.3.5 Month, day and year of manufacture 14.3.6 Use-before date 14.3.7 Description of device 14.3.8 Identification of contents 14.3.9 Identification of required connectors or configurations, if applicable 14.3.10 Instructions for opening the sterile barrier system 14.3.11 Designation of special-use devices |
| 85 | 14.4 Markings on the cochlear implant system 14.4.1 Individual device identification 14.4.2 Unequivocal identification 14.4.3 Interpretation of unequivocal identification markings |
| 86 | 15 Safety from unintentional biological effects of the cochlear implant system 15.1 Sterility of implantable device and tools 15.2 Particulate matter 15.3 Immunization protection against increased risk of infections due to surgery and device placement 16 Safety of secondary features of the cochlear implant system 16.1 Prevention of magnetic field interference with other medical devices |
| 87 | 16.2 Prevention of harm caused by headpiece retention 17 Safety of electrical stimulation 17.1 Electrical safety of applied signals to non-implantable parts |
| 88 | 17.2 Direct current leakage limit under use conditions 17.3 Charge and charge density limits for biphasic, charge-balanced pulses |
| 90 | Figure 13—Maximum stimulation limits for charge-balanced, biphasic pulses plotted as a function of chargeper phase (x axis) and charge density per phase (y axis) for k = 1.75 and a maximum charge density of 216μC/cm2 |
| 91 | 17.4 Phase duration requirements 17.5 Stimulation waveform requirements |
| 92 | Figure 14—Examples of possible symmetrical and asymmetrical stimulation waveforms that meet thecharge-balancing requirement 18 Safety of implantable energy sources 18.1 Documentation on implanted energy source |
| 93 | 19 Safety from heat sources 19.1 Thermal limit on outer surfaces of implantable parts 19.2 Thermal limit on outer surfaces of external sound processors 19.3 Thermal limit on outer surfaces of interfacing equipment |
| 94 | 19.4 Thermal limit on surfaces of external batteries in contact with skin |
| 95 | 20 Safety from unintended effects caused by the device 20.1 Maintenance of integrity of materials for life of the implantable device 20.2 Advanced warning of depletion of implantable power source |
| 96 | 20.3 Risk analysis of single-fault conditions 20.4 No unacceptable risk from intended use of active implant 20.5 Design assurance for removal and reimplantation compatibility 20.6 Hermeticity testing and compliance |
| 97 | 20.7 Implantable device internal moisture content 21 Safety and device immunity during magnetic resonance imaging 21.1 Conditions for safe MRI usage |
| 98 | 21.2 Displacement force and torque acting on the implantable component 21.2.1 Magnetically induced torque |
| 99 | 21.2.2 Magnetically induced displacement force 21.3 Gradient-induced vibration 21.3.1 Harm to the patient 21.3.2 Damage to the implant 21.4 Radio-frequency-induced heating |
| 100 | 21.5 Gradient-induced heating 21.6 Unintentional device output |
| 101 | 21.7 Implant magnet weakening 21.8 Maintenance of implant functionality during and after MRI scanning |
| 102 | 21.9 Imaging artifact 22 Device immunity to external stresses caused by medical treatment and procedures 22.1 Requirements for immunity 22.1.1 Immunity to diagnostic ultrasound energy 22.1.2 Immunity to therapeutic ionizing radiation |
| 103 | 22.1.3 Immunity to applied currents during surgery 22.1.4 Immunity to stresses during defibrillation 22.2 Testing for immunity 22.2.1 Testing for immunity to diagnostic ultrasonic energy |
| 104 | 22.2.2 Testing for immunity to therapeutic ionizing radiation 22.2.3 Testing for immunity to applied currents during surgery |
| 105 | Figure 15—Test setup for proof of protection from high-frequency currents caused by surgical equipment 22.2.4 Testing for immunity to external defibrillation stresses |
| 106 | Figure 16—RCL circuit for defibrillation test for active implantable medical device Figure 17—Form of Vtest pulses used in defibrillation test |
| 107 | 23 Device immunity to stresses of mechanical forces 23.1 Requirements for immunity 23.1.1 Immunity to vibration stresses during normal use and handling 23.1.2 Immunity to minor mechanical impact stresses during implantation handling 23.1.3 Immunity to mechanical impact stresses during normal use, including trauma |
| 108 | 23.1.4 Immunity of implantable antenna coil to mechanical impact stresses 23.1.5 Immunity of implantable antenna coil to stresses of mechanical flexing and bending 23.1.6 Immunity of implantable leads to tensile forces 23.1.7 Stress relief of junctions in implantable leads |
| 109 | 23.1.8 Immunity of implantable leads to flexural stresses 23.1.9 Specification of performance of implantable connectors 23.2 Testing for immunity 23.2.1 Testing for immunity to vibration stresses during normal use and handling 23.2.2 Testing for immunity to minor mechanical impact stresses during implantation handling |
| 110 | 23.2.3 Testing for immunity to mechanical impact stresses during normal use, including trauma 23.2.3.1 Test 1: Use case impact test applied by hammer to center of implant case 23.2.3.2 Test 2: Use case impact test applied by hammer to the weakest point or distributed over the device |
| 111 | 23.2.3.3 Reporting of test results for Test 1 and Test 2 23.2.4 Testing for immunity of implantable antenna coil to mechanical impact |
| 112 | Figure 18—Illustration showing the approximate locations for the five strikes for mechanical impact testingof the antenna coil 23.2.5 Testing for immunity of implantable antenna coil to stresses of mechanical flexing and bending 23.2.5.1 Test 1: Antenna coil out-of-plane flex testing |
| 113 | Figure 19—U-shaped flex bending of implantable antenna coil 23.2.5.2 Test 2: Antenna coil hinge flex testing relative to case 23.2.6 Testing for immunity of implantable leads to tensile forces |
| 114 | 23.2.6.1 Test 1: Test for specimen type A 23.2.6.2 Test 2: Insulation test for specimen type B |
| 115 | 23.2.7 Testing for stress relief of junctions in implantable leads 23.2.8 Testing for immunity of implantable leads to flexural stresses 23.2.8.1 Test 1: Gross flex testing of leads Figure 20—Stimulator drop test |
| 116 | 23.2.8.2 Test 2: Cyclical micro flex testing of leads Figure 21—Micro-Flex test fixture |
| 117 | 23.2.9 Testing of implantable connectors 24 Device immunity to stresses caused by atmospheric pressure changes 24.1 Minimum operating range 24.2 Requirements for immunity 24.2.1 Immunity to pressure changes during transit or normal use 24.2.2 Immunity to increases in atmospheric pressure during vocational or recreational activities |
| 118 | 24.3 Testing for immunity 24.3.1 Testing for immunity to pressure changes during transit or normal use 24.3.1.1 Test for static low atmospheric pressure 24.3.1.2 Test for cyclic low atmospheric pressure 24.3.1.3 Test for static high atmospheric pressure 24.3.1.4 Test for cyclic high atmospheric pressure |
| 119 | 24.3.2 Testing for immunity to increases in atmospheric pressure during vocational or recreational activities 25 Device immunity to stresses caused by temperature changes 25.1 Requirements for immunity to temperature extremes in transport and storage 25.2 Testing for immunity to temperature extremes in transport and storage 25.2.1 Test for low-temperature storage 25.2.2 Test for dry-heat storage |
| 120 | 25.2.3 Test for thermal cycling during storage and transport 26 Non-implantable device immunity to stresses caused by environment and usage 26.1 Requirements for immunity of sound processor and body-worn accessories |
| 121 | 26.1.1 Temperature 26.1.2 Relative humidity 26.1.3 Atmospheric pressure 26.1.4 Mechanical forces 26.1.5 Moisture ingress 26.2 Testing for immunity of sound processors and body-worn accessories |
| 122 | 26.2.1 Temperature 26.2.1.1 Test for low-temperature storage 26.2.1.2 Test for dry-heat storage 26.2.1.3 Test for thermal cycling during normal use |
| 123 | 26.2.1.4 Test for thermal cycling during storage and transport 26.2.2 Relative humidity 26.2.3 Atmospheric pressure 26.2.3.1 Test for static low atmospheric pressure 26.2.4 Mechanical forces |
| 124 | 26.2.4.1 Test for vibration 26.2.4.2 Test for free-fall shock (1 m; in-use orientation) 26.2.4.3 Test for free-fall shock (2 m; in-use/side-on orientation) 26.2.4.4 Test for free-fall shock (1 m; random orientation) 26.2.5 Moisture ingress |
| 125 | 26.3 Testing for immunity of cables Table 9—Summary of functional tests for cables |
| 126 | 26.3.1 Tug test Figure 22—Test setup for cable tug test 26.3.2 Test for multiple-pin plug cyclic connection |
| 127 | Figure 23—Test setup for 6-pin plug cyclic connection test 26.3.3 Bite test |
| 128 | Figure 24—Fixture for bite test 26.3.4 Pull test |
| 129 | Figure 25—Test setup for cable pull test 26.3.5 Flex test |
| 130 | 26.3.6 Connector engage and retention force 26.3.7 Cable safety 26.4 Requirements for immunity of non-body-worn accessories 26.4.1 Temperature 26.4.2 Relative humidity 26.4.3 Atmospheric pressure |
| 131 | 26.4.4 Mechanical forces 26.5 Testing for immunity of non-body-worn accessories 26.5.1 Temperature 26.5.1.1 Test for low-temperature storage 26.5.1.2 Test for dry-heat storage 26.5.1.3 Test for thermal cycling during normal use 26.5.1.4 Test for thermal cycling during storage and transport 26.5.2 Relative humidity 26.5.3 Atmospheric pressure 26.5.4 Mechanical forces 26.5.4.1 Test for vibration |
| 132 | 26.5.4.2 Test for free fall (1 m for handheld components) |
| 133 | Annex A (informative) Clinical identification and management of cochlear implant devicefailures |
| 135 | Annex B (informative) Clinical checklist prior to explantationSigns and symptoms checklist |
| 139 | Annex C (informative) Returned implant analysis |
| 145 | Annex D (informative) Indications of performance decline |
| 146 | Annex E (informative) Reliability reporting to regulatory bodies |
| 147 | Figure E.1—Acceptable graphical representations of implant reliability data |
| 155 | Annex F (informative) Pareto analysis |
| 156 | Table F.1—Device problems contributing to explantation, with associated normalized relative percent andcumulative percentage data (fictitious data) Figure F.1—Pareto plot of categories of device-related failures associated with the device explants reportedin Table F.1 (fictitious data) |
| 157 | Annex G (informative) Failed component return rate (FCRR) graphic and table Figure G.1—Sample graph of externals reliability data Table G.1—Sample table listing of externals reliability data |
| 158 | Figure G.2—Sample graph of externals reliability data |
| 159 | Annex H (informative) Reliability reporting template for the public and clinical community |
| 160 | Table H.1—Example of hypothetical reliability data from Manufacturer X for Device A |
| 161 | Figure H.1—Acceptable graphical representations of reliability data |
| 162 | Annex I (informative) Product specification data sheets |
| 163 | Table I.1—Manufacturer’s implant specifications |
| 164 | Table I.2—Manufacturer’s electrode specifications Table I.3—Manufacturer’s sound processing strategy |
| 165 | Table I.4—Manufacturer’s sound processor specifications |
| 167 | Table I.5—Manufacturer’s remote-control specifications |
| 168 | Annex J (informative) Mechanical testing of leads and interfaces to case bodies |
| 171 | Annex K (informative) Logic flow diagram of the relationships between the required testing,explant category classification, and reliability reporting to bothregulatory bodies and the public |
| 177 | Bibliography |
