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ANSI/AAMI CI86:2017 - Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting >
ANSI/AAMI CI86:2017 - Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting, 2017
- ANSI/AAMI CI86:2017; Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
- Objectives and uses of AAMI standards andrecommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 Units, abbreviations, and symbols [Go to Page]
- 5 General requirements for characterizing a cochlear implant system [Go to Page]
- 6 General requirements for implantable parts [Go to Page]
- 7 General requirements for non-implantable parts [Go to Page]
- 8 System-level inspection, characterization, and measurement [Go to Page]
- 9 Implantation support (RESERVED FOR FUTURE VERSIONS)
- 10 Post-implantation testing, in vivo assessment, and analysis of failed devices [Go to Page]
- 11 Reliability monitoring and reporting [Go to Page]
- 12 Information on use, warnings, and hazards [Go to Page]
- 13 General arrangement of the packaging system [Go to Page]
- 14 Markings on the packaging system and the cochlear implant device [Go to Page]
- 15 Safety from unintentional biological effects of the cochlear implant system [Go to Page]
- 16 Safety of secondary features of the cochlear implant system [Go to Page]
- 17 Safety of electrical stimulation [Go to Page]
- 18 Safety of implantable energy sources [Go to Page]
- 19 Safety from heat sources [Go to Page]
- 20 Safety from unintended effects caused by the device [Go to Page]
- 21 Safety and device immunity during magnetic resonance imaging [Go to Page]
- 22 Device immunity to external stresses caused by medical treatment and procedures [Go to Page]
- 23 Device immunity to stresses of mechanical forces [Go to Page]
- 24 Device immunity to stresses caused by atmospheric pressure changes [Go to Page]
- 25 Device immunity to stresses caused by temperature changes [Go to Page]
- 26 Non-implantable device immunity to stresses caused by environment and usage [Go to Page]
- Annex A (informative) Clinical identification and management of cochlear implant devicefailures
- Annex B (informative) Clinical checklist prior to explantationSigns and symptoms checklist
- Annex C (informative) Returned implant analysis
- Annex D (informative) Indications of performance decline
- Annex E (informative) Reliability reporting to regulatory bodies [Go to Page]
- Annex F (informative) Pareto analysis [Go to Page]
- Annex G (informative) Failed component return rate (FCRR) graphic and table [Go to Page]
- Annex H (informative) Reliability reporting template for the public and clinical community [Go to Page]
- Annex I (informative) Product specification data sheets [Go to Page]
- Annex J (informative) Mechanical testing of leads and interfaces to case bodies
- 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
- Bibliography [Go to Page]