Overview
ISO/TS 22218-1:2023 specifies standardized, text-based measurement data output formats for general ophthalmic examination devices. It defines how devices such as refractometers (REF), keratometers (KM), tonometers (TM), lensmeters (LM) and phoroptors (PHOR) should report ophthalmic examination device data (OEDD). The specification focuses on interoperability between devices, Ophthalmic Information Systems (OIS) and Hospital Information Systems (HIS), using XML/CDA-conformant structures. Images produced during exams are explicitly outside the scope.
Key topics and technical requirements
- Supported modalities: refraction, corneal curvature, intraocular pressure, spectacle lens power and visual acuity (REF, KM, TM, LM, PHOR).
- Text-based reporting only: OEDD addresses textual measurement outputs; image data are excluded.
- deviceCDA concept: a strict subset of CDA (Clinical Document Architecture) that devices can output when they cannot supply full CDA fields (e.g., patient or operator identity). OIS receives deviceCDA and embeds it into a full CDA/persistent report for HIS.
- OEDD structure and XML schema: defines top-level usage, data classifications, attribute values, units handling and an OEDD XML schema for device reports.
- Data classification & common data handling: rules for grouping multiple modalities in one file or separate files, and guidance on consistent handling of common data elements.
- Units and measurement conventions: includes handling of units (e.g., intraocular pressure can be reported in kPa or mmHg; conversion noted in the spec).
- Annex material: code lists and examples are provided (Annexes A–D include use cases, standard codes, and sample XML files).
Applications and who should use it
- Device manufacturers - implement standardized output formats (deviceCDA/OEDD XML) to ensure interoperability.
- OIS/HIS vendors and integrators - parse deviceCDA, assemble complete CDA persistent reports and manage device-to-HIS workflows.
- Hospitals, clinics and eye-care providers - reduce integration effort and errors when consolidating measurements from multiple device vendors.
- Software developers and informaticists - build middleware, viewers and analytics that consume standardized ophthalmic measurement data.
Practical benefits include streamlined device integration, consistent spectacle/contact lens prescription workflows and reliable transfer of intraocular pressure and other clinical measurements for diagnosis and follow-up (e.g., glaucoma assessment).
Related standards
- Clinical Document Architecture (CDA / CDA RMIM) - deviceCDA is a CDA subset.
- ISO standards cited for terminology (e.g., ISO 8596, ISO 13666) and ISO/TC 215 (Health informatics) guidance.
Keywords: ISO/TS 22218-1:2023, ophthalmic examination device data, OEDD, deviceCDA, OIS, HIS, refractometer, keratometer, tonometer, lensmeter, phoroptor, interoperability, CDA XML.