oSIST prEN ISO 14729:2026

SLOVENSKI STANDARD
01-oktober-2026
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč -
Mikrobiološke zahteve in preskusne metode za izdelke in postopki higienskega
ravnanja s kontaktnimi lečam (ISO/DIS 14729:2026)
Ophthalmic optics - Contact lens care products - Microbiological requirements and test
methods for products and regimens for hygienic management of contact lenses (ISO/DIS
14729:2026)
Augenoptik - Kontaktlinsenpflegemittel - Mikrobiologische Anforderungen und
Prüfverfahren für Produkte und Systeme zum Hygienemanagement von Kontaktlinsen
(ISO/DIS 14729:2026)
Optique ophtalmique - Produits d'entretien des lentilles de contact - Exigences
microbiologiques et méthodes d'essai des produits et protocoles d'entretien des lentilles
de contact (ISO/DIS 14729:2026)
Ta slovenski standard je istoveten z: prEN ISO 14729
ICS:
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 14729
ISO/TC 172/SC 7
Ophthalmic optics — Contact lens
Secretariat: DIN
care products — Microbiological
Voting begins on:
requirements and test methods for
2026-08-06
products and regimens for hygienic
Voting terminates on:
management of contact lenses
2026-10-29
Optique ophtalmique — Produits d'entretien des lentilles de
contact — Exigences microbiologiques et méthodes d'essai des
produits et protocoles d'entretien des lentilles de contact
ICS: 11.040.70
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.
This document has not been edited by the ISO Central Secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 14729:2026(en)
DRAFT
ISO/DIS 14729:2026(en)
International
Standard
ISO/DIS 14729
ISO/TC 172/SC 7
Ophthalmic optics — Contact lens
Secretariat: DIN
care products — Microbiological
Voting begins on:
requirements and test methods for
products and regimens for hygienic
Voting terminates on:
management of contact lenses
Optique ophtalmique — Produits d'entretien des lentilles de
contact — Exigences microbiologiques et méthodes d'essai des
produits et protocoles d'entretien des lentilles de contact
ICS: 11.040.70
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.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
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
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 14729:2026(en)
ii
ISO/DIS 14729:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
4.1 General .1
4.2 Stand-alone test (Inoculum challenge test) .2
4.3 Regimen test .3
5 Performance requirements . . 4
5.1 Stand-alone test: Primary criteria (see also Table 1) .4
5.1.1 Bacteria .4
5.1.2 Moulds and yeasts .4
5.2 Stand-alone test: Secondary criteria (see also Table 1) .4
5.3 Regimen test: Regimen criteria (see also Table 1) .4
6 Test methods . 5
6.1 Materials and reagents .5
6.1.1 Test organisms .5
6.1.2 Culture media and reagents .5
6.1.3 Test equipment .6
6.1.4 Test samples .6
6.1.5 Culture maintenance .6
6.2 Preparation of microbial challenge (Inoculum) .6
6.3 Stand-alone procedure .7
6.3.1 Inoculum challenge test procedure .7
6.3.2 Controls .8
6.3.3 Test report .9
6.4 Regimen procedure .9
6.4.1 Lens inoculation . .9
6.4.2 Lens treatment .10
6.4.3 Recovery of surviving challenge organisms (see Annex B for an example of a
membrane filtration procedure) .10
6.4.4 Controls .11
6.4.5 Test report .11
Annex A (informative) Test organisms from other culture collections .13
Annex B (informative) Example of a membrane filtration procedure . 14
Annex C (informative) Technical report: Virus testing .16
Annex D (informative) Technical report: Acanthamoeba testing . 17
Annex E (informative) Technical report: Artificial tears (organic soil) in laboratory testing .18
Bibliography . 19

iii
ISO/DIS 14729:2026(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for
voting. Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 14729 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
Annex A to Annex E of this International Standard are for information only.

iv
ISO/DIS 14729:2026(en)
Introduction
Products for contact lens disinfection by chemical means are intended to reduce microbial contamination
introduced during lens wear and removal, cleaning and storage and are required to contain antimicrobial
agents capable of achieving this.
It is essential that all liquid contact lens care products are sterile until opened. Dry products (tablets,
granules, etc.) should be subject to control of microbial contamination and should be dissolved in a suitable
diluent immediately prior to use. Multidose contact lens care products must be adequately preserved
or be packaged in a container designed and labelled to minimize the risk of injury resulting from in-use
contamination.
Contact lenses are normally subject to a regimen of cleaning and contact lens disinfection between periods
of wear. Aqueous solutions containing cleaning and/or disinfecting agents are commonly used for this
purpose. These products may be marketed as solutions or as tablets for dissolution immediately prior to use
in a suitable diluent such as saline.
The past 20 years of experience in the use and regulation of contact lens disinfecting products has shown
distinct disinfecting antimicrobial criteria for this class of medical devices. Ocular toxicology concerns,
process convenience and product comfort on the eye, have meant an evolution of products which maintain
a low incidence of contact lens associated ocular infection when used as instructed by the manufacturer.
This International Standard gives these distinct contact lens disinfecting antimicrobial criteria along with
annexes to explain why viruses (Annex C) and Acanthamoeba (Annex D) are not included as challenges.
Organic soil is not required for evaluation of contact lens care disinfecting products but may be used; an
informative annex (Annex E) is included to discuss organic soil in the context of contact lenses and contact
lens care products.
v
DRAFT International Standard ISO/DIS 14729:2026(en)
Ophthalmic optics — Contact lens care products —
Microbiological requirements and test methods for products
and regimens for hygienic management of contact lenses
1 Scope
This International Standard specifies two test methods for evaluating the antimicrobial activity of products
to be marketed for contact lens disinfection by chemical means and for products that are part of a contact
lens care regimen.
This International Standard is not applicable to the hygienic management of trial lenses.
NOTE General disinfection product standards are not applicable to contact lens care products, e.g. EN 1040:1997
and EN 1275:1997.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the definitions given in ISO 8320 apply together with the following.
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
contact lens disinfecting product
product that possesses cidal activity (kills, destroys and/or inactivates) meeting the primary criteria of the
stand-alone test specified in this International Standard
3.2
contact lens disinfecting regimen
contact lens care regimen designed to meet both the secondary criteria of the stand-alone test and the
regimen test as specified in this International Standard
3.3
contact lens disinfection
chemical or physical process to reduce the number of viable microorganisms as specified in the performance
requirement sections of this International Standard
4 Principle
4.1 General
The stand-alone test is designed to qualify individual solutions with a suitable level of antimicrobial activity
as contact lens disinfection products. The regimen test is designed to qualify individual solutions as part of
a contact lens disinfecting regimen. Products meeting the regimen test criteria shall also meet the minimum

ISO/DIS 14729:2026(en)
performance requirements of the stand-alone test. It is fundamental that such products (unopened
containers) are capable of meeting the requirements of the test throughout their labelled shelf life.
As described in Figure 1, contact lens care solutions which are designed to possess disinfecting properties
shall be tested in the stand-alone test first. If the respective primary criteria are met (see 5.1), the product
may be labelled as a contact lens disinfecting product. If the product fails the primary criteria of the stand-
alone test, the product must exhibit sufficient antimicrobial activity to meet the secondary criteria of the
stand-alone test as listed in 5.2. If these secondary criteria are met, the regimen test shall be performed in
order to qualify the product as part of a contact lens disinfecting regimen by meeting the regimen criteria
(see 5.3). If the product meets both the secondary criteria of the stand-alone test and the regimen test but
fails the primary criteria of the stand-alone test, it shall be labelled as part of a contact lens disinfecting
regimen.
The design of contact lens care products for cleaning and contact lens disinfection shall take into consideration
the needs of patient compliance and the probability of non-compliance. For example, disinfecting time must
be appropriate for contact lens wear.
NOTE Use of multiple or mixed microbial challenges can influence the apparent disinfecting activity of a particular
product. The evaluation of these variables together with testing against a larger panel of microorganisms and testing
of samples from partially used containers may be of value in developing a contact lens care product but are excluded
from the scope of this International Standard. (See Annex C and Annex D).
4.2 Stand-alone test (Inoculum challenge test)
The stand-alone test challenges a disinfecting product with a standard inoculum of a representative range
of microorganisms and establishes the extent of their viability loss at pre-determined time intervals
comparable with those during which the product may be used. The size of the microbial challenge chosen
in this test is not intended to be representative of the likely challenge in practice but to provide countable
numbers from which estimation of the rate and extent of viability loss can be determined.
In carrying out the test for antimicrobial activity the qualitative and quantitative compositions of the
product have to be known at the time of testing by either analytical testing or extrapolation.
Appropriate measures shall be taken to inactivate or remove residual antimicrobial agents during culturing
and counting of challenge organism survivors, and the effectiveness of these measures shall be validated.
The action of this process during the test shall be demonstrated by the construction of suitable controls.
NOTE For information about virus testing, see Annex C, and for Acanthamoeba testing, see Annex D.

ISO/DIS 14729:2026(en)
Key
a
Product may be labelled as a contact lens disinfecting product.
b
Product shall be labelled as part of a contact lens disinfecting regimen.
Figure 1 — Flow chart for stand-alone test and regimen test
4.3 Regimen test
This is a test which challenges a multifunctional disinfecting regimen with a standard inoculum of a
representative range of micro-organisms and which measures the viability loss after a predetermined time
interval; the inoculum is carried through the regimen by being applied to a contact lens.
This procedure is applicable to multifunctional disinfecting regimens which may include the steps of
cleaning, rinsing and soaking. In carrying out the regimen test procedure, the products are used in the
manner and quantity recommended in product labelling and/or patient instructions.
The disinfecting stage of any proposed contact lens disinfecting regimen evaluated by this test shall satisfy
the minimum requirements of the stand-alone test as described in Figure 1. Only those products that satisfy
the minimum performance requirements for the stand-alone test may be incorporated into a disinfecting
regimen.
In carrying out the test, qualitative and quantitative composition of all products used in the test regimen
have to be known at the time of testing, either by analytical testing or extrapolation.
Appropriate measures shall be taken to inactivate or remove residual antimicrobial activity during culturing
and counting of challenge organism survivors, and the effectiveness of these measures shall be validated.
The action of this process during the test shall be demonstrated by the construction of suitable controls.
NOTE For problems associated with the use of human-worn lenses, see Annex E.

ISO/DIS 14729:2026(en)
5 Performance requirements
5.1 Stand-alone test: Primary criteria (see also Table 1)
5.1.1 Bacteria
The number of each challenge organism recovered per millilitre shall be reduced by an average value of not
less than 99,9 % (3,0 logs) within the minimum recommended soaking period.
NOTE The value is determined by taking the average of the log reductions for each challenge organism for the
individual lots tested.
5.1.2 Moulds and yeasts
The number of each challenge organism recovered per millilitre shall be reduced by an average value of not
less than 90 % (1,0 log) within the minimum recommended soaking period with no increase at not less than
four times the minimum recommended soaking period within an experimental error of ± 0,5 logs.
NOTE The value is determined by taking the average of the log reductions for each challenge organism for the
individual lots tested.
5.2 Stand-alone test: Secondary criteria (see also Table 1)
Products failing to meet the criteria in 5.1.1 or 5.1.2 shall be evaluated by the regimen test procedure
described in 6.4, provided the sum of the averages is a minimum of 5,0 log units reduction for the three
species of bacteria within the recommended soaking period with a minimum average of 1,0 log unit
reduction for any single bacteria. Stasis for the yeast and mould shall be observed for the recommended
soaking period within an experimental error of ± 0,5 logs.
5.3 Regimen test: Regimen criteria (see also Table 1)
For each microbial species, the average regimen recovery count (for all lots tested) shall be no more than 10
cfu for each lens type/storage solution combination.
Data from more than one lens type should not be combined to calculate the average.
NOTE When qualifying a lens care product regimen for use with one lens type, the average count for each species
requires averaging the data from the 24 inoculated and treated lenses of the one lens type. When qualifying a lens
care product regimen for use with more than one lens type, the average count for each species by lens type would
require averaging the data from the 12 inoculated and treated lenses for each lens type. See Table 4 for numbers of
lenses to be used.
ISO/DIS 14729:2026(en)
Table 1 — Summary of performance requirements criteria for contact lens disinfection procedures
Average log reduction at soaking time
Test Fungi Bacteria
a a a a a
FS CA SM PA SA
Stand-alone test: Primary
1 1 3 3 3
Criteria
Stand-alone test: Secondary
b b c c c
Criteria
Regimen test: Regimen
≈ 4 to 5 ≈ 4 to 5 ≈ 4 to 5 ≈ 4 to 5 ≈ 4 to 5
d
criteria
a
PA = P. paraeruginosa ATCC 9027; SA = S. aureus ATCC 6538; SM = S. marcescens ATCC 13880; CA = C. albicans ATCC 10231;
FS = F. keratoplasticum ATCC 36031.
b
Stasis at the soaking time.
c
The minimum acceptable log reduction for all three bacteria combined is 5. The minimum acceptable log reduction for any
single bacterial type is 1.
d
Equivalent to an average of not more than 10 cfu per lens type/storage solution combination.
6 Test methods
6.1 Materials and reagents
The materials and reagents (i.e. the test organisms, media and reagents, equipment and samples) are
common to both the stand-alone procedure for disinfecting products and the regimen procedure for contact
lens disinfection.
6.1.1 Test organisms
The strains listed in Table 2 shall be used.
NOTE Test organisms from other culture collections that may be used are listed in Annex A.
Table 2 — Test organisms
Pseudomonas paraeruginosa ATCC 9027
Staphylococcus aureus ATCC 6538
Serratia marcescens ATCC 13880
Candida albicans ATCC 10231
Fusarium keratoplasticum ATCC 36031
6.1.2 Culture media and reagents
6.1.2.1 Potato dextrose agar (PDA).
6.1.2.2 Tryptone soya agar (TSA).
6.1.2.3 Sabouraud Dextrose Agar (SDA).
6.1.2.4 Dulbecco's Phosphate Buffered Saline, without calcium chloride and magnesium chloride
(DPBS): 200 mg/l KCl, 200 mg/l KH PO , 8 000 mg/l NaCl, and 2 160 mg/l Na HPO ·7H O or suitable diluent.
2 4 2 4 2
6.1.2.5 Dulbecco's Phosphate Buffered Saline, plus 0,05 % (mass/volume) polysorbate 80 (DPBST)
or suitable diluent.
ISO/DIS 14729:2026(en)
6.1.2.6 Validated neutralizing agents/media as required, for example, Dey-Engley Neutralising Broth
1)
(DEB) and Letheen Broth .
6.1.3 Test equipment
The following common laboratory equipment is required.
6.1.3.1 Sterile pipettes.
6.1.3.2 Swabs.
6.1.3.3 Tubes.
6.1.3.4 Petri dishes (90 mm to 100 mm × 20 mm).
6.1.3.5 Incubator.
6.1.3.6 Spectrometer, for determination of cell density.
6.1.3.7 Instrument for colony counting.
6.1.3.8 Centrifuge.
6.1.4 Test samples
The product to be tested shall be representative of the product to be marketed. Aliquots should be taken
directly from the final product container immediately prior to testing.
Three lots of product shall be tested. Each lot of product shall be tested with a separate inoculum preparation
for each challenge organism.
6.1.5 Culture maintenance
Maintain the test cultures as recommended by the curator of the appropriate culture collection.
Cultures should be no greater than 5 passes removed from the depository stock (ATCC, NCIB, NCTC, NCPF or
other recognized culture depository; see Annex A). Each pass is a subculture of the previous pass.
6.2 Preparation of microbial challenge (Inoculum)
The preparation of the microbial challenge organisms (inoculum) is common to both the stand-alone
procedure for disinfecting products and the regimen procedure for contact lens disinfection.
For the regimen procedure for contact lens disinfection, organic soil may be included as part of the inoculum.
See Annex E for an example.
Culture each test organism on agar slopes under the conditions given in Table 3.
1) Dey-Engley Neutralising Broth (DEB) and Letheen Broth are examples of suitable products available commercially. This
information is given for the convenience of users of this International Standard and does not constitute an endorsement
by ISO of this product.
ISO/DIS 14729:2026(en)
Table 3 — Media and incubation conditions for growth of challenge organisms
Temperature
Organism Medium Incubation time
°C
P. paraeruginosa TSA 30 to 35 18 h to 24 h
S. aureus TSA 30 to 35 18 h to 24 h
S. marcescens TSA 30 to 35 18 h to 24 h
C. albican SDA 20 to 25 42 h to 48 h
or C. albicans SDA 30 to 35 18 h to 24 h
F. keratoplasticum PDA 20 to 25 10 d to 14 d
Use sterile DPBST or suitable diluent to harvest each culture; wash the surface growth, transfer it to a
suitable vessel and vortex. Filter the F. keratoplasticum suspensions through sterile glass wool, cheese cloth
or gauze to remove hyphal fragments.
After harvesting, the cultured organisms may be washed using centrifugation. The bacterial suspensions
may be filtered (e.g. 3 µm to 5 µm pore size) to produce a single cell dispersion. Then adjust all challenge cell
7 8
suspensions with DPBST or other suitable diluent to a concentration of between 1 × 10 cfu/ml and 1 × 10
cfu/ml. Estimate the approximate cell concentration of each suspension by measuring the turbidity of the
suspension or a dilution of the suspension using a spectrophotometer. The actual concentration of colony
forming units per millilitre shall be determined for each suspension, e.g. by the plate count method, at the
time of the test.
If a centrifuge is used, each centrifugation should be conducted at 20 °C to 25 °C for no longer than the
equivalent of 10 min at 4 000 × g or less. Longer centrifugation times may be required at lower speeds.
Use bacterial and yeast cell suspensions on the day of preparation. Spore suspensions may be used up to
seven days following preparation if stored under refrigeration (2 °C to 8 °C).
6.3 Stand-alone procedure
6.3.1 Inoculum challenge test procedure
6.3.1.1 Prepare one or more tubes (for each lot tested) containing a minimum of 10 ml of test product
solution per challenge organism.
NOTE Sample tubes are used rather than lens cases to allow effective technical execution of the test. Since
incompatibilities can exist between solution ingredients and tube materials, tubes of an appropriate material, which
are compatible with the ingredients, should be used.
Inoculate the sample tube of the product to be tested with a suspension of test organisms sufficient to
5 6
provide a final count of between 1,0 × 10 and 1,0 × 10 cfu/ml. Ensure that the volume of inoculum does not
exceed 1 % of the sample volume. Ensure complete dispersion of the inoculum by adequate mixing.
6.3.1.2 Store the inoculated product at 20 °C to 25 °C. The temperature shall be monitored using a
calibrated device and the temperature documented.
If the product is sensitive to light it should be protected during the period of the test.
6.3.1.3 Take 1,0 ml aliquots of the inoculated product for determination of viable count at 25 %, 50 %,
75 % and 100 % of the minimum recommended disinfecting time for all organisms, and, in addition, not less
than 400 % of the minimum recommended disinfecting time for yeast and mould. If overnight contact lens
disinfection is recommended, use a soaking time of 8 h.
6.3.1.4 Subject each of the 1,0 ml aliquots, removed at the specified time intervals, to a suitable series of
decimal dilutions in validated neutralizing media. Mix the suspension well by vortexing vigorously and let

ISO/DIS 14729:2026(en)
stand to allow neutralization to be completed. Neutralization conditions shall be based on recovery medium
control testing (see 6.3.2.2).
If an antimicrobial agent in the formulation cannot be adequately inactivated or neutralized, eliminate it
using a validated membrane filtration procedure (see Annex B).
6.3.1.5 Determine the viable count of organisms in appropriate dilutions by preparation of triplicate
plates (unless otherwise justified) of a suitable recovery medium (e.g. TSA for bacteria and SDA for mould
and yeast).
If membrane filtration has been employed to remove or neutralize antimicrobial agents, culture the
membranes on these media as appropriate.
If the pour plate method is utilized, keep the agar for pour plates below 50 °C prior to pouring.
The agar media used for determination of viable counts may also contain antimicrobial inactivators or
neutralizers, if required.
6.3.1.6 Incubate bacterial recovery plates at 30 °C to 35 °C. Incubate yeast recovery plates at 20 °C to 25 °C
or 30 °C to 35 °C. Incubate mould recovery plates at 20 °C to 25 °C. Incubation times for optimal recovery
of bacteria, yeast and moulds shall be determined. Minimum incubation times shall be based on recovery
medium control testing (see 6.3.2). Record the number of cfu observed on countable plates.
NOTE Plates should be observed periodically during incubation to prevent the occurrence of uncountable plates
due to overgrowth.
6.3.1.7 Determine the average number of colony forming units on countable plates. Calculate the microbial
reduction at the specified time points.
NOTE Countable plates refer to 30 cfu/plate to 300 cfu/plate for bacteria and yeast, and 8 cfu/plate to 80 cfu/
0 -1
plate for moulds, except when colonies are observed only for the 10 or 10 dilution plates.
6.3.1.8 The absence of microorganisms shall be documented, e.g. by recording an "0” or "NR” (no recovery),
when plates for all dilutions of a sample at a single time point have zero colonies.
6.3.2 Controls
6.3.2.1 Inoculum Control
Prepare an inoculum count by dispersing an identical aliquot of the inoculum into the same volume as used
5 6
in 6.3.1.1 of a suitable diluent (e.g. DPBST) to achieve a final concentration of 1,0 × 10 cfu/ml to 1,0 × 10 cfu/
ml. Ensure that the volume of inoculum does not exceed 1 % of the sample volume. Ensure dispersion of the
inoculum by adequate mixing. Evaluate this control sample for cfu/ml at the beginning of the test in order
to demonstrate the suitability of the medium used for growth of the test organism and provide an estimate
of the initial inoculum concentration. Plate the appropriate aliquot from each tube onto the recovery agar
plates in triplicate (unless otherwise justified).
6.3.2.2 Recovery medium control
Vortex a 1/10 dilution of the disinfecting product in the validated neutralizing broth (1 ml into 9 ml). Let it
stand to allow neutralization to be completed. Prepare a second control tube with 10 ml of a suitable diluent
(e.g. DPBST). Inoculate the tubes with sufficient inoculum to result in 10 cfu/ml to 100 cfu of challenge
organism per plate. Incubate for an appropriate period of time at ambient temperature but not long enough
to allow multiplication of the inoculated organisms. Plate the appropriate aliquot from each tube onto the
recovery agar plates in triplicate (unless otherwise justified).
Incubate bacterial recovery plates at 30 °C to 35 °C. Incubate yeast recovery plates at 20 °C to 25 °C or 30 °C
to 35 °C. Incubate mould recovery plates at 20 °C to 25 °C. Determine minimum incubation times for optimal
recovery of bacteria, yeast and moulds.

ISO/DIS 14729:2026(en)
Check that the recovery from the neutralizer broth is at least 50 % of the recovery in the second control
tube. Perform this control for each challenge organism.
If a dilution of greater than 1/10 is required for neutralization, then membrane filtration shall be used.
Validate the neutralization of the product with each challenge organism initially and as appropriate.
6.3.2.3 Control specification
If any control value is outside that specified, repeat the procedure as the associated test is invalid.
6.3.3 Test report
The test report shall specify:
a) reference to this International Standard;
b) the identification of the product:
1) name of the product;
2) batch number;
3) expiry date;
4) manufacturer;
5) storage conditions;
6) active substances(s) and its/their concentration(s) (as available);
c) the name/s of the operator/s;
d) deviations from the protocol;
e) period of incubation;
f) storage time for inoculated product;
g) results obtained.
If a product passes the primary criteria of the stand-alone test, it may be labelled as a contact lens disinfecting
product. If the product only passed the secondary criteria of the stand-alone test, and the regimen test, it
shall be labelled as part of a contact lens disinfecting regimen.
6.4 Regimen procedure
6.4.1 Lens inoculation
Carry out the test using lens types representative of those with which the regimen is intended to be used,
e.g. low water non-ionic, high water ionic, silicone acrylate, etc. New and unused lenses should be used for
this test. When qualifying a lens care product regimen with a single lens type, inoculate each of eight lenses
for each microbial species per lot of test product; this results in testing a total of 24 lenses per formulation
per species. When qualifying a lens care product regimen for use with all hydrophilic lens types, inoculate
each of four lenses from Group 1 (low water content non-ionic) and four lenses from Group 4 (mid- and high
water content ionic) for each microbial species per lot of test product; this results in testing a total of 12
lenses per lens type per formulation per species. Additional hydrophilic lens types may be tested; however,
a minimum of four lenses per lens type per species per lot of formulation shall be used. In qualifying a lens
care product regimen for use with all non-hydrophilic lens types, inoculate four silicone acrylate lenses and
four fluorosilicone acrylate lenses per microbial species per lot of test product for a total of 12 lenses per
lens type per formulation per species. Qualification of a lens care product regimen with all hydrophilic and

ISO/DIS 14729:2026(en)
all non-hydrophilic lenses requires testing with Group 1 and 4 hydrophilic lens types and silicone acrylate
and fluorosilicone acrylate non-hydrophilic lenses.
The number of lenses required for the test is given in Table 4.
Place test and control lenses, with concave surface uppermost, in a sterile petri dish. Inoculate each lens by
placing 0,01 ml of inoculum on the underside of the lens at the point of contact between the petri dish and
the lens. Also inoculate the upper surface by application of 0,01 ml of the same inoculum directly on to the
concave surface of the lens.
Allow the inoculum to adsorb onto each lens for between 5 min and 10 min at 20 °C to 25 °C.
Table 4 — Number of lenses required
Number of lenses per microbial species
Qualification for Qualification for all Qualification for all
c b, d b, d
a single lens type hydrophilic lenses non-hydrophilic lenses
a
Test sample
(e.g. Group 1) Group 1 Group 4 Silicone Fluoro-silicone
acrylate acrylate
Solution LOT 1 8 4 4 4 4
Solution LOT 2 8 4 4 4 4
Solution LOT 3 8 4 4 4 4
d
Total 24 12 12 12 12
a
Minimum of three lots of lens care product to be tested.
b
If testing more than one lens type, a minimum of four lenses per lens type per lot of lens care product per microbial species
shall be used.
c
If testing only one lens type, a minimum of eight lenses per lens type per lot of lens care product per microbial species shall
be used.
d
Qualification of a lens care product regimen with all hydrophilic lenses and all non-hydrophilic lenses would require, at a
minimum, testing the product with four lenses from each of the following lens types: Group 1 and Group 4 hydrophilic lenses and
silicone acrylate and fluorosilicone acrylate non-hydrophilic lenses.
6.4.2 Lens treatment
After adsorption of the inoculum, treat the lenses as described in the manufacturer's instructions to the
consumer for contact lens disinfection, including all steps of cleaning, rinsing and soaking as specified by
the manufacturer. Test protocols should specify the parameters of the cleaning and rinsing procedures (e.g.
rubbing and rinsing times and rinse volumes).
6.4.3 Recovery of surviving challenge organisms (see Annex B for an example of a membrane
filtration procedure)
6.4.3.1 Dispense a suitable volume of a validated neutralizing medium into the filtration apparatus.
(B.1.2.1). Neutralization conditions shall be based on recovery medium control testing (see 6.4.4.2).
6.4.3.2 Transfer the entire contents of each test lens case (lens and solution) into the neutralizing medium
in the filtration apparatus (B.1.2.2) having determined the neutralization exposure time prior to filtration
(see Annex B).
6.4.3.3 Apply reduced pressure and filter the solution. Rinse the filter with a suitable volume of
neutralizing medium.
6.4.3.4 Aseptically transfer the contact lens onto a bed of agar medium appropriate for recovery of the
test organism. Pour some of the same agar medium (kept below 50 °C) over the lens and allow to cool.

ISO/DIS 14729:2026(en)
6.4.3.5 Apply the test filter to the surface of a plate of appropriate solid media (could be the same as used
in 6.3.1.5).
6.4.3.6 Incubate bacterial recovery plates at 30 °C to 35 °C. Incubate yeast recovery plates at 20 °C to 25 °C
or 30 °C to 35 °C. Incubate mould recovery plates at 20 °C to 25 °C. Incubation times for optimal recovery
of bacteria, yeast and moulds shall be determined. Minimum incubation times shall be based on recovery
medium control testing (see 6.4.4). Record the number of cfu observed on countable plates. Plates should be
observed periodically during incubation to prevent the occurrence of uncountable plates due to overgrowth.
6.4.4 Controls
6.4.4.1 Lens inoculation control
For each microbial species tested, transfer three inoculated lenses to tubes of a suitable diluent (e.g. DPBST).
Vortex for 30 s. Serially dilute and plate out appropriate dilutions in triplicate (unless otherwise justified) to
permit a count of viable cells present. This count confirms that the number of organisms on the lens at the
time of the regimen challenge is adequate. The mean of the counts should be not less than 2 × 10 cfu/lens
and not greater than 2 × 10 cfu/lens.
6.4.4.2 Recovery medium control
Prepare filtration apparatus in triplicate (unless otherwise justified) as described in 6.4.3 with suitable
volumes of the neutralizing medium and disinfecting product (see Annex B). Let it stand to allow
neutralization to be completed. Add 5 cfu to 100 cfu challenge organisms (one organism per filter), filter and
cultivate as described in 6.4.3.
Confirm the inoculum on a suitable medium in triplicate (unless otherwise justified).
Ensure that the recovery on the filter from the neutralizer
...