ANSI/AAMI CI86:2017
Current
The latest, up-to-date edition.
COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING
Hardcopy , PDF
English
06-01-2017
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
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