ISO/TS 22218-2:2023 PDF

Name: ISO/TS 22218-2:2023 — Health informatics — Ophthalmic examination device data — Part 2: Specular microscope
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Health informatics — Ophthalmic examination device data — Part 2: Specular microscope

Название (английский):

ISO/TS 22218-2:2023

Health informatics — Ophthalmic examination device data — Part 2: Specular microscope

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 35
Дата публикации:: 5 января 2023 г.
Издание:: ISO TS 22218 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

This document specifies the data output formats for the specular microscope. The data are usually sent from the specular microscope to either an ophthalmic information system (OIS) or a hospital information system (HIS). This document addresses text-based analysis reporting of the specular microscope measured and analysed data such as the central corneal thickness, the density of endothelial cells per 1 mm2, the coefficient variant, and the ratio of endothelial cells with a hexagonal shape.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO/TS 22218-2:2023 defines standardized data output formats for specular microscopes used in ophthalmic practice. The Technical Specification specifies how text-based analysis results (for example, central corneal thickness, endothelial cell density per mm², coefficient of variation, and hexagonality) are formatted and exchanged from devices to higher-level systems such as an Ophthalmic Information System (OIS) or a Hospital Information System (HIS). The specification aligns device output with the Ophthalmic Examination Device Data (OEDD) model and is compliant with CDA® Release 2 syntax.

Key topics and technical requirements

Data types and measurements: Standardized reporting of corneal endothelium metrics - central corneal thickness, endothelial cell density (cells/mm²), coefficient of variation (CV), and hexagonality (HEX).

deviceCDA concept: Defines a strict subset of CDA (deviceCDA) to allow devices to send examination data without full patient/operator metadata; the OIS enriches and converts this into a complete CDA for HIS submission.

OEDD structure and XML schema: Layouts for embedding SPECULAR data in a CDA XML file, including support for combining multiple device types (SPECULAR, REF, KM, TM, LM, PHOR) in one document.

Data classification and codes: Use of coded section attributes (e.g., LOINC-style codes such as 100066-0 for SPECULAR) to identify device data types and enable consistent parsing.

Handling common data and units: Guidance on common header elements, unit handling, and how to ignore unrecognized/private extensions to maintain interoperability.

Supporting materials: Annexes include use cases (Annex A), standard codes for common and ophthalmic data (Annices B and C), sample XML files (Annex D), and a bibliography.

Applications and who should use it

Device manufacturers of specular microscopes - to produce interoperable, standardized data output.

OIS and HIS vendors / integrators - to import, normalize and persist specular microscope results and produce CDA-compliant reports.

Hospital IT and clinical engineers - to implement workflows that integrate corneal endothelial metrics into electronic medical records.

Clinical teams (ophthalmologists, optometrists) - benefit indirectly through reliable data exchange supporting diagnosis (dry eye, Fuchs’ dystrophy, bullous keratopathy), monitoring and contact lens fitting.

Regulatory and standards teams - for compliance and device-to-system interoperability planning.

Related standards

ISO/TS 22218-1 (series context)

HL7 CDA® Release 2 (syntax compliance)

LOINC (for laboratory/measurement coding)

Keywords: ISO/TS 22218-2:2023, specular microscope, health informatics, ophthalmic examination device data, deviceCDA, OIS, HIS, endothelial cell density, corneal thickness, OEDD, CDA R2, XML schema, interoperability.

ISO/TS 22218-2:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who should use it

Related standards

Технические детали

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