ISO/FDIS 11979-1
(Main)Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
Implants ophtalmiques — Lentilles intraoculaires — Partie 1: Vocabulaire
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FINAL DRAFT
International
Standard
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
2025-12-11
Part 1:
Vocabulary
Voting terminates on:
2026-02-05
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
Part 1:
Vocabulary
Voting terminates on:
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 10
Bibliography .11
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 170, Ophthalmic optics,in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 11979-1:2018), which has been technically
revised.
The main changes are as follows:
— definitions of non-accommodative posterior chamber “simultaneous vision” (SVIOL) lenses that include
the subtypes of MIOL (multifocal), EDF (extended depth of focus) and FVR (full visual range) IOLs have
been added;
— definitions of properties related to SVIOLs have been added.
A list of all parts in the ISO 11979 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.
iv
FINAL DRAFT International Standard ISO/FDIS 11979-1:2025(en)
Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
1 Scope
This document contains definitions of terms related to intraocular lenses as well as definitions related to
the methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms.
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
accelerated shelf-life study
study to establish an initial expiration dating period by using exaggerated storage conditions by increased
temperature to be validated by real time study
3.2
accommodating intraocular lens
AIOL
IOL providing focusing from far point to near point by changing the dioptric power of the eye
3.3
accommodative amplitude
difference in refractive power between the near point and the far point of the eye
3.4
addition power
difference between the far power and the near power
3.5
additional wrapping
protective packaging used in addition to the primary packaging which can be used to maintain sterility of
the intraocular lens
3.6
anterior chamber lens
IOL designed to be placed entirely in the anterior chamber of the eye
3.7
aspheric intraocular lens
IOL having at least one optical surface whose curvature varies radially from the vertex to the periphery
3.8
axial displacement in compression
displacement of optic along the optical axis when the IOL is compressed to a specified diameter taking the
uncompressed state as reference
3.9
axis mark
indicator of the meridian of lowest dioptric power of a toric IOL
Note 1 to entry: See Figure 1.
3.10
back focal length
BFL
distance from the back vertex of the IOL to the focal point with collimated light incident on-axis upon the IOL
3.11
base power
dioptric power that is intended to provide an in-focus image of an object at far (infinity)
Note 1 to entry: Base power is the same as far power.
3.12
best-case subject
subject with no pre-operative ocular pathology detected at any time, e.g. no macular degeneration, and no
previous surgery for the correction of refractive errors
3.13
body
part of an IOL incorporating the optic excluding the haptics
Note 1 to entry: See Figure 1.
3.14
clear optic
diameter of concentric circle with the optical axis of an intraocular lens, containing only features of the
intraocular lens belonging to the optical design
Note 1 to entry: See Figure 1.
3.15
closed-loop intraocular lens
IOL model which contains two loops, each loop having both ends attached to the body of the optic
3.16
compression force
force exerted by the haptics of the IOL when compressed to a specified diameter
Key
1 overall diameter
2 positioning hole
3 clear optic
4 body
h vault height
h sagittal distance
Figure 1 — Overall diameter, vault height, sagittal distance, clear optic, body, positioning hole and
axis mark
3.17
cumulative adverse events
total number of adverse events that have occurred at any time up to a specified post-operative time point
3.18
custom-made device
device specifically made in accordance with a duly qualified medical practitioner's written prescription,
which gives, under his/her responsibility, specific design characteristics and is intended for the sole use of a
particular patient
Note 1 to entry: Mass-produced devices, which need to be adapted to meet the specific requirements of the medical
practitioner, are not considered to be custom-made devices.
3.19
cut-off wavelength
wavelength at which spectral transmission drops below a defined level
3.20
cylindrical power
difference in dioptric power between the meridians with the highest and the lowest dioptric powers
3.21
delivery system
system, either preloaded or combined, in which the IOL is compressed and/or folded and delivered into the eye
3.22
device history record
collection of records and reports assembled in a batch package, containing or referring to the relevant
information pertaining to the manufacture and control of that batch of devices
3.23
dioptric power
reciprocal of the reduced paraxial focal length in situ for light, where paraxial focal length is the distance
between the back principal plane and the back paraxial focal point, and reduced paraxial focal length is the
paraxial focal length divided by the refractive index of the surrounding medium
-1
Note 1 to entry: The unit for expressing dioptric power is the reciprocal metre (m ). The special name for this unit is
“dioptre”, for which the symbol “D” is used.
Note 2 to entry: Refer to ISO 11979-2 for the test conditions.
Note 3 to entry: For certain IOL optical designs, the use of paraxial focal length is not appropriate.
3.24
dynamic fatigue
durability of an IOL following cyclic compressive loading of the IOL haptic to a specified dimension
3.25
effective focal length
EFL
distance from the back principal plane to the focal point with collimated light incident on-axis upon the IOL
3.26
expiration date
termination of shelf-life, after which the IOL is not to be used
3.27
extended depth of
...
ISO /TC 172/SC 7
Secretariat: DIN
Date: 2025-10-28xx
Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
FDIS stage
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 11
Bibliography . 12
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments., in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 170, Ophthalmic optics,in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 11979-1:2018), which has been technically
revised.
The main changes are as follows:
— — definitions of non-accommodative posterior chamber “simultaneous vision” (SVIOL) lenses that
include the subtypes of MIOL (multifocal), EDF (extended depth of focus) and FVR (full visual range) IOLs
have been added;
— — definitions of properties related to SVIOLs have been added.
A list of all parts in the ISO 11979 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.
iv
Ophthalmic implants — Intraocular lenses
—
Part 1:
Vocabulary
1 Scope
This document contains definitions of terms related to intraocular lenses as well as definitions related to the
methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms in the English version 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 3.1
accelerated shelf-life study
study to establish an initial expiration dating period by using exaggerated storage conditions by increased
temperature to be validated by real time study
3.2 3.2
accommodating intraocular lens
AIOL
IOL providing focusing from far point to near point by changing the dioptric power of the eye
3.3 3.3
accommodative amplitude
difference in refractive power between the near point and the far point of the eye
3.4 3.4
addition power
difference between the far power and the near power(s)
3.5 3.5
additional wrapping
protective packaging used in addition to the primary packaging which couldcan be used to maintain sterility
of the intraocular lens
3.6 3.6
anterior chamber lens
IOL designed to be placed entirely in the anterior chamber of the eye
3.7 3.7
aspheric intraocular lens
IOL having at least one optical surface whose curvature varies radially from the vertex to the periphery
3.8 3.8
axial displacement in compression
taking the uncompressed state as reference, the displacement of optic along the optical axis when the IOL is
compressed to a specified diameter taking the uncompressed state as reference
3.9 3.9
axis mark
indicator of the meridian of lowest dioptric power of a toric IOL
Note 1 to entry: See 0Figure 1.
3.10 3.10
back focal length
BFL
distance from the back vertex of the IOL to the focal point with collimated light incident on-axis upon the IOL
3.11 3.11
base power
dioptric power that is intended to provide an in-focus image of an object at far (infinity)
Note 1 to entry: Base power is the same as far power.
3.12 3.12
best-case subject
subject with no pre-operative ocular pathology detected at any time, e.g. no macular degeneration, and no
previous surgery for the correction of refractive errors
3.13 3.13
body
part of an IOL incorporating the optic excluding the haptics
Note 1 to entry: See 0Figure 1.
3.14 3.14
clear optic
diameter of circle concentric circle with the optical axis of an intraocular lens, containing only features of the
intraocular lens belonging to the optical design
Note 1 to entry: See 0Figure 1.
3.15 3.15
closed-loop intraocular lens
IOL model which contains two loops, each loop having both ends attached to the body of the optic
3.16 3.16
compression force
force exerted by the haptics of the IOL when compressed to a specified diameter
11979-1_ed5fig1.EPS
Key
1 overall diameter
2 positioning hole
3 clear optic
4 body
h1 vault height
h2 sagittal distance
Figure 1 — Overall diameter, vault height, sagittal distance, clear optic, body, positioning hole and
axis mark
3.17 3.17
cumulative adverse events
total number of adverse events that have occurred at any time up to a specified post -operative time point
3.18 3.18
custom-made device
device specifically made in accordance with a duly qualified medical practitioner's written prescription, which
gives, under his/her responsibility, specific design characteristics and is intended for the sole use of a
particular patient
Note 1 to entry: Mass-produced devices, which need to be adapted to meet the specific requirements of
the medical practitioner, are not considered to be custom-made devices.
3.19 3.19
cut-off wavelength
wavelength at which spectral transmission drops below a defined level
3.20 3.20
cylindrical power
difference in dioptric power between the meridians with the highest and the lowest dioptric powers
3.21 3.21
delivery system
system, either preloaded or combined, in which the IOL is compressed and/or folded and delivered into the
eye
3.22 3.22
device history record
collection of records and reports assembled in a batch package, containing or referring to the relevant
information pertaining to the manufacture and control of that batch of devices
3.23 3.23
dioptric power
reciprocal of the reduced paraxial focal length in situ for light, where paraxial focal length is the distance
between the back principal plane and the back paraxial focal point, and reduced paraxial focal length is the
paraxial focal length divided by the refractive index of the surrounding medium
-1
Note 1 to entry: The unit for expressing dioptric power is the reciprocal metre (m ). The special name
for this unit is “dioptre”, for which the symbol “D” is used.
Note 2 to entry: Refer to ISO 11979-2 for the test conditions.
Note 3 to entry: For certain IOL optical designs, the use of paraxial focal length is not appropriate.
3.24 3.24
dynamic fatigue
durability of an IOL following cyclic compressive loading of the IOL haptic to a specified dimension
3.25 3.25
effective focal length
EFL
distance from the back principal plane to the focal point with collimated light incident on-axis upon the IOL
3.26 3.26
expiration date
termination of shelf-life, after which the IOL is not to be used
3.27 3.27
extended depth of focus intraocular lens
EDF IOL
SVIOL providing useful visual acuity levels from far through intermediate focal distances
Note 1 to entry: Useful visual acuity levels are provided in ISO 11979-7.
3.28 3.28
far point
farthest distance at which an object can be focused on
3.29 3.29
far power
dioptric power that is intended to provide an in-focus image of an object at far (infinity)
Note 1 to entry: Far power is the same as base power.
3.30 3.30
far power configuration
configuration of an accommodating intraocular lens in the eye that is intended to result in a distant object
being in focus on the retinal plane
3.31 3.31
finished intraocular lens lot
specific quantity of uniform IOLs intended to fall within a set of specified characteristics produced according
to a single manufacturing order or during the same cycle of manufacture, and completed by sterilization,
packaging and labelling
3.32 3.32
full vis
...
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