Implant service interface
Any qualified clinic should be able to diagnose, charge, update and repair any optical implant, whoever made it and whether or not its maker still exists. Version 2.1, published 3 July 2023.
- Version
- 2.1, published 3 July 2023. Version 1.0 was published in 2019.
- Status
- Published. Next review due 2026; the working group began it in September.
- Implemented by
- Six of the nine makers covered by the Independent Implant Register, including Kiroshi Opticals for all devices sold since 2021
- Licence
- Text CC BY 4.0. Implementation free, with no royalty or registration.
1 Scope
This standard applies to optical implants: devices placed in or on the eye or optic nerve that process light or images for the wearer. It sets out the interface through which a clinic may communicate with an implant for service, and the information a maker must publish about each device.
2 The service interface
2.1 An implant shall accept service connections from any clinic holding a valid service credential issued under section 4, not only from the maker’s own clinics.
2.2 Through the service interface, a clinic shall be able to read battery health, error logs and firmware version; run the self-test; charge the device; and install any firmware the maker has released for it.
2.3 The service interface shall not require a connection to the maker’s servers. A device shall be serviceable in a clinic with no internet connection.
Note. Requirement 2.3 was the most contested in the 2023 revision. Two makers argued that offline service prevents them from detecting counterfeit parts. The working group decided that a wearer’s sight should not depend on a server being online.
3 Support plans
3.1 Before a device is first sold, its maker shall publish a support plan stating the minimum period for which spare parts, batteries and firmware fixes will be available, which shall not be less than fifteen years from the last sale.
3.2 The support plan shall state what will happen to the device’s firmware, documentation and service credentials if the maker ends support early or ceases to exist, including the name of an independent escrow holder.
3.3 A maker ending support for a device shall give wearers at least five years’ notice and publish the firmware source, documentation and service credentials through the escrow holder at the end of support.
4 Service credentials
4.1 Service credentials shall be issued by an independent body to any clinic that meets published criteria of training and equipment. Makers shall not refuse credentials to clinics that service their competitors’ devices.
Why this standard exists
KF-OS 1 began after the SEIRAN 2 was discontinued in 2019 with a support period of five years, and after the Raven Corvid lost all support overnight when its maker was dissolved. Neither would meet section 3 today. The SEIRAN 2 was made by Kiroshi Opticals. The company has implemented the standard for every device it has sold since 2021, and has not applied it to devices sold before then. We have asked it to.