prEN ISO 11979-1

SLOVENSKI STANDARD
01-oktober-2024
Nadomešča:
SIST EN ISO 11979-1:2019
Očesni vsadki (implantati) - Intraokularne leče - 1. del: Slovar (ISO/DIS 11979-
1:2024)
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO/DIS 11979-1:2024)
Ophthalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO/DIS 11979-1:2024)
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO/DIS 11979-
1:2024)
Ta slovenski standard je istoveten z: prEN ISO 11979-1
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 11979-1
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
Part 1: 2024-08-29
Vocabulary
Voting terminates on:
2024-11-21
Implants ophtalmiques — Lentilles intraoculaires —
Partie 1: Vocabulaire
ICS: 11.040.70; 01.040.11
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
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INTERNATIONAL STANDARD UNTIL
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Reference number
ISO/DIS 11979-1:2024(en)
DRAFT
ISO/DIS 11979-1:2024(en)
International
Standard
ISO/DIS 11979-1
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
ICS: 11.040.70; 01.040.11
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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This document is circulated as received from the committee secretariat. BE CONSIDERED IN THE LIGHT OF THEIR
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11979-1:2024(en)
ii
ISO/DIS 11979-1:2024(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 9

iii
ISO/DIS 11979-1:2024(en)
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 172 , Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This fifth edition cancels and replaces the forth edition (ISO 11979-1:2012), which has been technically
revised.
The main changes are as follows:
— definitions of non-accommodative posterior chamber “Simultaneous Vision Range” (SVIOL) lenses that
include the subtypes of MIOL (Multifocal), EDF (Extended Depth of Focus) and FVR (Full Visual Range) IOLs.
— definitions of properties related to SVIOLs
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
DRAFT International Standard ISO/DIS 11979-1:2024(en)
Ophthalmic implants — Intraocular lenses —
Part 1:
Vocabulary
1 Scope
This document contains definitions of terms related to intraocular lenses and definitions of the methods
used to evaluate them.
NOTE 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
accelerated shelf-life study
stability study designed to increase the rate of chemical or physical degradation of a product by using
exaggerated storage conditions (e.g. temperature, humidity) to determine kinetic degradation parameters
to predict the tentative expiration dating period
3.2
accommodating intraocular lens
AIOL
IOL which provides continuous 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 distance power and the near or intermediate power
3.5
additional wrapping
container used in addition to the primary packaging which could 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

ISO/DIS 11979-1:2024(en)
3.7
aspheric intraocular lens
IOL having at least one optical surface which differs from a segment of a sphere optical surface
3.8
axial displacement in compression
taking the uncompressed state as reference, displacement of optic along the optical axis when the IOL is
compressed to a specified diameter
3.9
axis mark
Indicator of the meridian of lowest dioptric power of a Toric IOL
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
power that is intended to provide an in-focus image of an object at far (infinite)
3.12
best-case subject
subject with no pre-operative ocular pathology detected at any time, no macular degeneration detected at
any time, and no previous surgery for the correction of refractive errors
3.13
body
central part of an intraocular lens incorporating the optic
Note 1 to entry: See Figure 1.
3.14
clear optic
diameter of circle concentric with the optical axis of an intraocular lens, containing only features of the
intraocular lens belonging to the optical design. Axis marks and positioning holes cannot be in the clear optic
Note 1 to entry: See Figure 1.
3.15
closed-haptic IOL
IOL model, which contains two or more haptics, each haptic 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
3.17
compression force after decay
residual compression force when the IOL has been confined to a specified diameter under in situ conditions
for a specified time
3.18
compression force decay
the process by which the compression force of an IOL is reduced over time when the IOL is held in a
compressed state
3.19
cumulative adverse events
total number of adverse events that have occurred at any time up to a specified time point post-operatively

ISO/DIS 11979-1:2024(en)
3.20
custom-made device
device specifically made in accordance with a duly qualified medical practitioner's written prescription,
which gives, under his 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.
3.21
cut-off wavelength
wavelength at which spectral transmission drops below defined level
Key
1 overall diameter
2 positioning hole
3 clear optic
4 body
5 axis mark
h vault height
h sagittal distance
Figure 1 — Overall diameter, vault height, sagittal distance, clear optic, body, positioning hole and
axis mark
3.22
cylindrical power
difference in dioptric power between the meridians with the highest and the lowest dioptric powers
3.23
delivery system
instrument(s) or system used to implant the IOL into the eye

ISO/DIS 11979-1:2024(en)
3.24
depth of focus
focal range of the eye, from the far focus to a near focus, through which a specified acuity level is achieved
3.25
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
3.26
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.
3.27
dynamic fatigue
fatigue durability by compressing the IOL to a specified dimension and giving cyclic compressive loading to
the haptic
3.28
effective focal length (EFL)
distance from the second principal plane to the focal point with collimated light incident on-axis upon the IOL
3.29
expiration date
termination of shelf-life, after which the intraocular lens is not to be used
3.30
extended depth of focus IOL
EDF IOL
EDF IOL is an SVIOL providing useful visual performance for far and intermediate distances
3.31
far point
farthest distance at which one can focus on an object
3.32
far power
base power is same as far power which in used in MIOL, SAVIOL to differentiate from additional power(s)
3.33
far power configuration
configuration of an accommodating intraocular lens in the eye that is intended to result in a distant object
being in focus in the retinal plane
3.34
finished intraocular lens lot
specific quantity of intraocular lens
...