ANSI AAMI CI86 pdf free download

ANSI AAMI CI86 pdf free download.Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.
3.83 reliability: Ability of a product to function and meet specified performance, for a specified period of time, under the life cycle application conditions.
3.84 reliabilIty test: Experiment carried out in order to measure, quantify, or classify a reliability measure or property of an item.
IEC 61 649:2008
3.85 reporting party: Individual or organization publishing clinical cochlear implant system data or the analysis thereof.
ISO 5841 -2:2014
3.86 returned device: A medical device that has been in use in the field by a patient or clinician and is returned to the manufacturer because it does not perform its intended function.
3.87 revision surgery: Any surgical intervention required without the removal of the device. This does not include known surgical procedures required by approved labeling.
3.88 risk: Combination of the severity of a harm and the likelihood of that harm occurring.
3.89 risk-based: Characteristic of a process that uses the risk assessment to determine a course of action.
3.90 sales packaging: Packaging that protects and identifies the active implantable medical device dunng storage and handling by the purchaser.
NOTE—The sales packaging may be enclosed in further packaging (e.g., a shipping package”) for delivery.
ISO 14708-1:2014
3.91 sample size: Number of devices required to provide data that meets a required statistical level of confidence for a given statistical analysis method.
3.92 serial number: Unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a device from other devices with the same model designation.
ISO 14708-7:2013
3.93 shIpping package: Packaging that protects the sales packaging during shipping from the manufacturer.
3.94 sound-processing strategy: Algorithm by which the device processes sound information to create electrical and/or acoustic stimulation delivered during the device’s intended medical application.
3.95 sound processor: Non-implantable component of a cochlear implant system that is capable of receiving acoustic information from an external source, modifying it, and transmitting this information via either a radio-frequency link or a transcutaneous plug to the receiver/stimulator of an implant.
5.2.2.1 Sound processors and body-worn accessories
The documentation shall list the sound processors and body-worn accessories that are components of the device system and shall describe their functions.
The manufacturer shall demonstrate compliance to this section.
NOTE 1—Sound processors to be included in the inventory are those used with the cochlear implant system in conventional (purely electrical) and combined acoustic and electrical stimulation. In basic operation, sound processors receive and process sound signals while being battery-powered and transmit processed signals and energy to the implant. Headpiece coils are considered to be an integral part of the sound processor and are inc’uded as specific items in the inventory listing. If the sound processor communicates with an acoustic hearing instrument as part of its function, the hearing instrument is included in the inventory. The information to be provided about cables connecting the headpiece coil to the sound processor is specified in Section 5.2.2.3.
NOTE 2—Body-worn accessories are ancillary devices that might be used with sound processors in order to extend the processors’ basic operation or body-worn configuration. Examples are battery packs, FM systems that connect to the sound processors, accessory microphones, and remote controls. The information to be provided about accessory cables that either interconnect the body-worn accessories with the sound processor or connect signals to the accessory or auxiliary connectors of sound processors is specified in Section 5.2.2.3.ANSI AAMI CI86  pdf download.