ISO/TS 22218-1:2023
(Main)Health informatics — Ophthalmic examination device data — Part 1: General examination devices
Health informatics — Ophthalmic examination device data — Part 1: General examination devices
This document specifies the measurement data output formats for devices used in general ophthalmic examiniations, including the following modalities: — Refractometer (REF) Refraction — Keratometer (KM) Corneal curvature — Tonometer (TM) Intraocular pressure — Lensmeter (LM) Spectacle lens power — Phoroptor (PHOR) Visual acuity This document only addresses text-based device reporting of ophthalmic examination device data (OEDD). Images generated as needed during an ophthalmic examination are outside the scope of this document.
Informatique de santé — Données relatives aux dispositifs d'examen ophtalmique — Partie 1: Dispositifs pour les examens généraux
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 22218-1
First edition
2023-01
Health informatics — Ophthalmic
examination device data —
Part 1:
General examination devices
Informatique de santé — Données relatives aux dispositifs d'examen
ophtalmique —
Partie 1: Dispositifs pour les examens généraux
Reference number
© ISO 2023
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 4
4.1 General . 4
4.2 deviceCDA and persistent examination reports . 4
4.3 Data classification constitution in the file . 5
4.4 OEDD structure . 6
4.4.1 General . 6
4.4.2 Data classifications . 7
4.4.3 Attribute value and classification . 7
4.4.4 Handling of common data . 7
4.4.5 Handling of ophthalmic examination data . 9
4.4.6 Handling of units of measurement . 11
4.5 OEDD XML schema . 11
Annex A (informative) Ophthalmic examination data cases .12
Annex B (informative) Standard codes used for common data .13
Annex C (informative) Standard codes for ophthalmic examination data .14
Annex D (informative) Sample files .54
Bibliography . 153
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
A list of all parts in the ISO 22218 series can be found on the ISO website.
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iv
Introduction
Opthalmic devices are used in hospitals and clinics to conduct examinations for patients. The primary
devices used in these opthalmic examinations provide measurement of refraction, corneal curvature,
intraocular pressure, lens power and visual acuity. Almost all patients who consult for a diagnosis in
ophthalmology undergo these examinations. Most ophthalmic hospitals and clinics use devices in these
examinations to provide the needed measurements. Since many different vendors supply the devices
to perform these measurements, the interoperability of examination results is important. In addition,
standard procedures for mutually communicating these measurements are required between the
ophthalmic examination devices and the Ophthalmic Information System (OIS).
These examinations are indispensable not only for ophthalmic medical care but also for prescriptions
for spectacles and contact lenses. Additionally, intraocular pressure measurement is important for
other ophthalmic procedures such as glaucoma assessment.
However, due to the differing data formats provided by these ophthalmic examination devices and
the lack of interoperability, integration of this information is difficult and potentially error prone.
Integration of each device’s information into an OIS or hospital information system (HIS) therefore
requires significant individual effort for each manufacturer’s device.
This document specifies the content and format for ophthalmic examination device measurements,
identifying that information that may be included in examination reports, as well as how it should be
formatted when communicated to an OIS, HIS or other similar system.
v
TECHNICAL SPECIFICATION ISO/TS 22218-1:2023(E)
Health informatics — Ophthalmic examination device
data —
Part 1:
General examination devices
1 Scope
This document specifies the measurement data output formats for devices used in general ophthalmic
examiniations, including the following modalities:
— Refractometer (REF) Refraction
— Keratometer (KM) Corneal curvature
— Tonometer (TM) Intraocular pressure
— Lensmeter (LM) Spectacle lens power
— Phoroptor (PHOR) Visual acuity
This document only addresses text-based device reporting of ophthalmic examination device data
(OEDD). Images generated as needed during an ophthalmic examination are outside the scope of this
document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
refractometer
device that measures the refractive state of the eye
Note 1 to entry: Measuring the refractive state of the eye is necessary to determine the refractive power of a
correction lens to restore normal vision.
Note 2 to entry: Measuring devices can provide both analog or digital readouts.
3.2
intraocular pressure
IOP
measurement of the fluid pressure inside the eye
Note 1 to entry: This measurement is typically expressed in kPa; however, some devices also provide it in mmHg.
1 mmHg = 0,133 3 kPa
3.3
measured intraocular pressure
measured IOP
intraocular pressure that obtained without any compensation
Note 1 to entry: See corrected intraocular pressure (3.4).
3.4
corrected intraocular pressure
corrected IOP
intraocular pressure that results from compensation of the corneal thickness based on the measured
intraocular pressure
3.5
refractive power
ability of a lens or optical surface to change the curvature of incident wavefront or its direction by
refraction
3.6
interpupillary distance
PD
distance between the centres of the pupils when the eyes are fixating an object at an infinite distance in
the straight-ahead position
3.7
corneal curvature
radius of curvature of the anterior cornea
Note 1 to entry: It is expressed in mm.
3.8
visual acuity
number characterizing the ability of the visual system to recognize optotypes
[SOURCE: ISO 8596:2017, 3.3]
3.9
sphere
spherical power
sph
S
value of the back vertex power of a spherical-power lens or the vertex power in one of the two principal
meridians of an astigmatic-power lens, depending on the principal meridian chosen for reference
[SOURCE: ISO 13666:2019, 3.12.2]
3.10
cylindrical power
cylinder
cyl
plus or minus the astigmatic difference, depending on the principal meridian chosen for reference
Note 1 to entry: The commonly used symbol for cylindrical power is C.
[SOURCE: ISO 13666:2019, 3.13.7, modified — Note 1 to entry modified.]
3.11
Maddox
type of ophthalmic examation that uses a Maddox rod
Note 1 to entry: A point source through a small Maddox rod (filter with thin cylindrical red glasses lined up) forms
a vertical red line when round glasses horizontally stand in a line, and forms a horizontal red line when round
glasses stand vertically in a line. For this property, a Maddox tangent scale (scale with a cruciform scale and a
point source at the center) is used to measure a heterophoria angle. By using a small Maddox rod horizontally
(vertically) and viewing a tangent scale, a vertical (horizontal) red line can be seen with each eye. By seeing a
point source at the center, a red line can be seen at the off-center position with the fellow eye. Measurement is
performed by reading the horizontal (vertical) scale of the position.
3.12
accommodation
type of repeated measurement that is performed using the time required for focusing on a visual target
Note 1 to entry: This measurement reveals the nature of accommodation disorder by classifying the appearance
of accommodation time into several types as contraction time, that is the time required for focusing on a near
visual target, or relaxation time for the time required for focusing on a far visual target.
3.13
AC/A ratio
ratio of the accommodative convergence amount for +1,0D and the accommodation stimulation
Note 1 to entry: This is determined using a fusion test.
3.14
vergence
simultaneous movement of both eyes in different directions
Note 1 to entry: This occurs when the line of sight is moved to objects at different distances (depths) from a viewer.
The movement of both eyes directed inward when one looks into the close distance is called “convergence”, and
the movement of both eyes directed outward when one looks into the far distance is called “divergence”.
Note 2 to entry: Vergence is one of disconjugate eye movement of right and left eyeballs in the opposite directions,
which is different from conjugate eye movement in which both eyes move in the same direction such as saccade
...
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