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

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Status
Published
Publication Date
04-Jan-2023
Current Stage
6060 - International Standard published
Due Date
21-Jun-2022
Completion Date
05-Jan-2023
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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/TS 22218-1:2023(E)
© ISO 2023
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ISO/TS 22218-1:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
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
© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

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

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

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.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
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.
© ISO 2023 – All rights reserved
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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.
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ISO/TS 22218-1:2023(E)
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

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

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.
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ISO/TS 22218-1:2023(E)
[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

and pursuit eye movement. In addition, the word “vergence” is commonly used for eye movement in a horizontal

direction; however, besides this, vertical vergence and cyclovergence are included. The convergence divergence

movement changes this convergence angle. The simultaneous movement of both eyes in opposite directions

occurs when the line of sight is moved to objects at different depths; the convergence movement occurs when one

looks into the close distance from the far distance; and on the contrary, the divergence movement occurs when

one looks into the far distance from the close distance.
3.15
stereopsis

ability to use sensory information from both eyes to recognize three dimensional shaps sterioscopically

Note 1 to entry: This occurs when a planar image projected on the retina is subjected to integrative action in the

visual areas of the cerebral cortex, and is recognized as a three-dimensional shape in three dimensional space.

3.16
depth perception
ability to recognize the difference in distance to multiple targets
3.17
phoria

state where the ocular position during the binocular vision test is normal; however, ocular displacement,

infravergance or supravergence, appears as fusion disturbance
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ISO/TS 22218-1:2023(E)
3.18
aniseikonia

condition in which one eye perceives an image to be larger compared to the other eye and can occur in a

horizontal or vertical direction
3.19
ophthalmic information system
OIS

computer system that acquires, stores, retrieves and manages ophthalmic images and examination data

Note 1 to entry: The OIS gather and manage examination information from various ophthalmic devices and

submit persistent examination reports in CDA RMIM format to HIS.
3.20
deviceCDA

subset of the CDA RMIM dataset that only includes the information contained in a device

Note 1 to entry: Most ophthalmic examination devices do not support all the mandatory information required by

a complete CDA document, such as patient or operator identification. Additional information can be associated

after the report is sent to an OIS or HIS. For additional details, see Clause 4.
3.21
hospital information system
HIS

comprehensive, integrated information system designed to manage all the aspects of a hospital's

operation

Note 1 to entry: In many implementations, a HIS covers hospital's operation such as medical, administrative,

financial, and legal issues and the corresponding processing of services.
[11]
[SOURCE: IS4H-MM ]
3.22
optotype
variable-sized type used in testing visual acuity
4 Specifications
4.1 General

OEDD provides standards both for transferring clinical ophthalmic examination data from various

types of examination devices to an OIS, as well as submitting persistent reports based on those

examination data from an OIS to an HIS.
Exemplary use cases are detailed in Annex A

It is possible to handle multiple data types such as REF, kerato, IOP, and lens meter within one XML file.

It is acceptable to compile REF, kerato, IOP, and lens meter in one file or separate them into different

files. Within the file, is the top tag in accordance with the rules for CDA.

For details, refer to 4.3.

The standard codes used in this document are shown in Annex C, and sample XML files are shown in

Annex D.
4.2 deviceCDA and persistent examination reports

Most OEDD devices only output examination data and related information, and cannot provide

additional data items such as Patient, Operator, Custodian and Authentication.
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ISO/TS 22218-1:2023(E)

For such devices, OEDD introduces deviceCDA, a strict subset of CDA, that allows devices to transfer

examination data and related information as a deviceCDA dataset without the additional detailed

patient identification information that is required in complete CDA documents.

OIS plays the role of receiving examination data and related information as a deviceCDA dataset from

a device, and then submitting a persistent examination report to an HIS with additional information

required for the complete CDA dataset.

deviceCDA is not a complete CDA dataset but still conforms to the same syntax. OIS therefore prepares

a complete OEDD that includes the CDA RMIM dataset with information such as Patient, Operator,

Custodian and Authentication, and inserts the deviceCDA dataset received from the device into the

OEDD. See Figure 1.
Figure 1 — Concept of a deviceCDA
4.3 Data classification constitution in the file

Both a deviceCDA and a complete CDA file has and as the

top tag.

It is possible to collect information from all the OEDD classifications into one file, or they can be

separated into different deviceCDA/Complete CDA files. In the case of a single composite OEDD

deviceCDA/Complete CDA document, the data tags that are common across the devices shall be

specified once, and the OEDD data tags integrated separately. See Table 1.

When encountering a data classification not included in the OEDD specification (e.g., private extensions),

in which case, implementations shall ignore non-recognized data classifications and process the known

data classifications accordingly.
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ISO/TS 22218-1:2023(E)
Table 1 — Example deviceCDA file data block layouts
Common Data Common Data Common Data Common Data

REF Data REF Data TM Data LM Data




KR Data LM Data KR Data





TM Data PHOR Data





LM Data





File 1 File 2 File 3 File 4
4.4 OEDD structure
4.4.1 General

This document is compliant with CDA-R2. For this reason, the complete detailed file structure can be

reviewed in HL7 CDA® Release 2.
In this document, only descriptions particular to ophthalmology are included.

1) HL7 CDA is the registered trademark of Health Level Seven International. This information is given for the

convenience of users of this document and does not constitute an endorsement by ISO of the product named.

© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
4.4.2 Data classifications

The data classifications of refractometer, keratometer, tonometer and such are maintained as attribute

value (type) of tags.
4.4.3 Attribute value and classification
Table 2 shows ophthalmic examination device data classification values.
Table 2 — OEDD Device Classification Values
Attribute value (code) Data classification
79898-3 Refractometer data
95298-6 Keratometer data
79896-7 Tonometer data
95318-2 Lensmeter data
79895-9 Auto Phoroptor data

Figure 2 shows the examples with refractometer (REF), keratometer (KM), tonometer (TM), lensmeter

(LM) and phoropter (PHOR) data These examications are designated using LOINC® codes.

Figure 2 — OEDD section tags
4.4.4 Handling of common data
4.4.4.1 General

Common data, such as ophthalmic examination title, are described in the CDA Header part between the

tag and < structuredBody>. This common data will be present only once in a file.

4.4.4.2 Common data tags

The items to be described in the necessity column have the following meanings. See details in Table 3.

2) LOINC is the registered trademark of Regenstrief Institute. This information is given for the convenience of

users of this document and does not constitute an endorsement by ISO of the product named.

© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
Table 3 — Common data tags
Tag name Description Necessity
ClinicalDocument CDA-R2 D
Type ID. The compliant CDA R2 D
typeId
specifications are identified.
ID for unique identification D
id specified at hospitals, etc. or
groups
A code which represents the D
code
reporting category.
title Ex) Ophthalmic examinations D
Date & time of creation of the C
effectiveTime
file (yyyymmddhhmmss)
Confidentiality level code. D
The confidentiality value in
the HL7 vocabulary domain is
confidentialityCode
used.
Ex) code="N"
languageCode D
languageCode
Ex) code="jpn"
versionNumber Document version number D
recordTarget Patient D
patientRole Patient information D
Patient No. D
(number of the order of exam-
id b
ination)
Ex) extension="123456"
patient Patient name C
name Alphabetic expression C
family family name C
given Given name C
Regional ideographic or pho- O
name
netic name
family family name O
given Given name O
Patient's sex C
administrativeGenderCode
EX) F/M/UN
Patient’s date of birth (yyyym- C
birthTime
mdd)
author Author D
The items in the Necessity column have the following meanings:
D - Tags and values are necessary for both Complete CDA and deviceCDA
C - Tags and values are necessary for Complete CDA
O - No tags or values are necessary
Multiple settings are allowed for Patient No. Also, nullFlavor="NI" is allowed.

Multiple settings are allowed for Patient name. If First name and Last name cannot be separated, the Last name should

be entered in the First name section. Also, nullFlavor="NI" is allowed.
Refer to Annex B.
© ISO 2023 – All rights reserved
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ISO/TS 22218-1:2023(E)
TTabablele 3 3 ((ccoonnttiinnueuedd))
Tag name Description Necessity
Date & time of creation D
time
(yyyymmddhhmmss)
Information of the organiza- D
assignedAuthor tion that prepares the docu-
ment.
Assigned Author ID D
"NI" : If id is none
assignedAuthoringDevice Assigned Authoring Device D
Model name and No. for dis- D
manufacturerModelName tinction among the devices of
the same model
softwareName Software and ROM version D
representedOrganization Represented Organization C
Represented Organization ID C
"NI": If id is none
name Company name C
custodian custodian C
assignedCustodian Assigned Custodian C
Represented Custodian Organ- C
representedCustodianOrganization
ization
Represented Custodian Organ- C
ization ID
"NI": If id is none
documentationOf Operator C
serviceEvent code C
serviceEvent
EX) classCode="ACSN"
code serviceEvent code C
performer type code C
performer
EX) typeCode="PRF"
Function Code C
functionCode
EX) code="SNRS"
assignedEntity assignedEntity C
id Operator ID C
The items in the Necessity column have the following meanings:
D - Tags and values are necessary for both Complete CDA and deviceCDA
C - Tags and values are necessary for Complete CDA
O - No tags or values are necessary
Multiple settings are allowed for Patient No. Also, nullFlavor="NI" is allowed.

Multiple settings are allowed for Patient name. If First name and Last name cannot be separated, the Last name should

be entered in the First name section. Also, nullFlavor="NI" is allowed.
Refer to Annex B.
4.4.5 Handling of ophthalmic examination data
4.4.5.1 General

Examination data are described in the section of the deviceCDA as follows:

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ISO/TS 22218-1:2023(E)



---(Refer to 4.4.5.2 for detailed content)



4.4.5.2 Ophthalmic examination data tags
Table 4 shows basic composition of tags used for ophthalmic examination data:
Table 4 — Ophthalmic examination data tags
Tag name Description Necessity
component CDA-R2 component D
structuredBody D
Medication information tag can be optionally defined here -
component CDA-R2 component O
Section O
section
Ex) classCode="DOCSECT" mood-
Code="EVN"
Title of drug to be administrated O
title
(mydriatic agent)
Drug name O
text
EX) Mydrin-P
entry O
Ex) classCode="OBS" mood- O
Code="EVN"
observation
(OBS=observation, EVN=exami-
nation results)
drug code O
code
EX) 1319810Q1053
Examination tag defined here -
component CDA-R2 component D
section Section D
LOINC®'s Exam Details Code D
code
EX) Set code of LOINC® for REF:
"79898-3"
The items in the Necessity column have the following meanings:
D - Tags and values are necessary for both Complete CDA and deviceCDA
O - No tags or values are necessary
b d

This drug code is for the mydriatic solution (Mydrin® -P) listed in the National Health Insurance Drug Price List

commonly used in Japan.

Refer to Annex C for detail of examination data measured by each ophthalmic examination device.

Mydrin is the registered trademark of Santen Pharmaceutical Co., Ltd. This information is given for the convenience of

users of this document and does not constitute an endorsement by ISO of the product named.

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ISO/TS 22218-1:2023(E)
TTabablele 4 4 ((ccoonnttiinnueuedd))
Tag name Description Necessity
examination title D
title
(HTML format)
text detail of examination D
entry D
Ex) classCode="OBS" mood- D
Code="EVN"
observation
(OBS=observation, EVN=exami-
nation results)
Examination code D
code
Ex) Refraction Sphere Right=
"28687-2"
Date & time of creation of the file D
effectiveTime
(yyyymmddhhmmss)
Value examination data & unit D
entryRelationship Detailed examination data D
sequenceNumber Measurement number D
Ex) classCode="OBS" mood- D
Code="EVN"
observation
(OBS=observation, EVN=exami-
nation results)
Examination code D
code
Ex) Refraction Sphere Right=
"28687-2"
value examination data & unit D
The items in the Necessity column have the following meanings:
D - Tags and values are necessary for both Complete CDA and deviceCDA
O - No tags or values are necessary
b d

This drug code is for the mydriatic solution (Mydrin® -P) listed in the National Health Insurance Drug Price List

...

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