AAMI CI86 : 2017

Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
1 Scope
2 Normative references
3 Definitions
4 Units, abbreviations, and symbols
5 General requirements for characterizing a
   cochlear implant system
6 General requirements for implantable parts
7 General requirements for non-implantable parts
8 System-level inspection, characterization, and
   measurement
9 Implantation support (RESERVED FOR FUTURE
   VERSIONS)
10 Post-implantation testing, in vivo assessment,
   and analysis of failed devices
11 Reliability monitoring and reporting
12 Information on use, warnings, and hazards
13 General arrangement of the packaging system
14 Markings on the packaging system and the
   cochlear implant device
15 Safety from unintentional biological effects
   of the cochlear implant system
16 Safety of secondary features of the cochlear
   implant system
17 Safety of electrical stimulation
18 Safety of implantable energy sources
19 Safety from heat sources
20 Safety from unintended effects caused by the
   device
21 Safety and device immunity during magnetic
   resonance imaging
22 Device immunity to external stresses caused by
   medical treatment and procedures
23 Device immunity to stresses of mechanical forces
24 Device immunity to stresses caused by atmospheric
   pressure changes
25 Device immunity to stresses caused by temperature
   changes
26 Non-implantable device immunity to stresses caused
   by environment and usage
Annex A (informative) - Clinical identification and
        management of cochlear implant device failures
Annex B (informative) - Clinical checklist prior to
        explantation Signs and symptoms checklist
Annex C (informative) - Returned implant analysis
Annex D (informative) - Indications of performance declin
Annex E (informative) - Reliability reporting to regulato
        bodies
Annex F (informative) - Pareto analysis
Annex G (informative) - Failed component return rate
        (FCRR) graphic and table
Annex H (informative) - Reliability reporting template
        for the public and clinical community
Annex I (informative) - Product specification data
        sheets
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 both regulatory bodies
        and the public
Bibliography

Describes requirements, test procedures, methods and labeling for active implantable medical devices intended to treat hearing impairment by means of electrical stimulation of the cochlea.