ISO 8124-12:2023

INTERNATIONAL ISO
STANDARD 8124-12
First edition
2023-08
Safety of toys —
Part 12:
Microbiological safety
Sécurité des jouets —
Partie 12: Sécurité microbiologique
Reference number
© ISO 2023
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General . 2
5 Risk assessment . 3
5.1 General . 3
5 . 2 E v a lu at ion . 3
5.3 Exception for testing . 3
6 Microbiological cleanliness of toy materials . 4
7 Microbiological challenge (preservation effectiveness) . 4
8 Test procedures . 5
8.1 General requirements . 5
8.2 Microbiological cleanliness . 5
8.3 Preservation effectiveness . 5
Annex A (informative) Process water — Manufacturing aqueous toy materials .6
Bibliography . 7
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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This document was prepared by Technical Committee ISO/TC 181, Safety of toys.
A list of all parts in the ISO 8124 series can be found on the ISO website.
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iv
Introduction
This document is largely based upon existing requirements in ASTM F963, with some modifications to
narrow the scope and facilitate use of the document in multiple jurisdictions.
However, it should not be construed that a toy manufactured in conformity with this document will
be in full compliance with relevant national toy safety requirements in the market where the product
is intended to be distributed. The user of this document is therefore advised to be aware of relevant
national requirements.
Conformity with the requirements of this document will minimize potential hazards associated with
toys due to lack of microbiological cleanliness or inadequate preservation, either of which can result
in illness or injury resulting from use of the toy in its intended play modes (normal use) as well as
unintended play modes (reasonably foreseeable abuse).
This document will not, nor is it intended to, eliminate parental responsibility in the appropriate
selection of toys. Nor will this document eliminate the need for parental supervision in situations where
children of various ages have access to the same toy(s).
v
INTERNATIONAL STANDARD ISO 8124-12:2023(E)
Safety of toys —
Part 12:
Microbiological safety
1 Scope
This document specifies acceptable criteria for microbiological cleanliness and adequacy of
preservation of the specified toy materials. The requirements in this document apply to all toys that
are, contain or are supplied with aqueous materials (e.g. paste, putty, liquid or gel). In addition, this
document applies to toys that are or include a cosmetic (including those intended for use on a toy as
well as on the child). Powders and similar substances intended to be mixed with water are also within
the scope of this document.
The cleanliness and preservation effectiveness requirements are applicable to a toy as it is initially
received by the consumer in an unopened and undamaged container and do not apply after a toy is
subjected to reasonably foreseeable conditions of normal use and abuse, unless specifically noted
otherwise. The microbial limits and test methods contained in this document are inappropriate to
apply to products that are consumer complaint returns, as there is no way to establish what conditions
the toys have been subject to before being returned.
The following are excluded from the scope of this document:
— materials that are inaccessible during normal use or reasonably foreseeable abuse;
— powder or powder-like materials intended to show biological phenomena, e.g. shrimp eggs, seeds,
soil;
— food.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 6222, Water quality — Enumeration of culturable micro-organisms — Colony count by inoculation in
a nutrient agar culture medium
ISO 7899 (all parts), Water quality — Detection and enumeration of intestinal enterococci
ISO 9308 (all parts), Water quality — Enumeration of Escherichia coli and coliform bacteria
ISO 11930, Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
ISO 17516, Cosmetics — Microbiology — Microbiological limits
ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
ISO 18416, Cosmetics — Microbiology — Detection of Candida albicans
ISO 18787, Foodstuffs — Determination of water activity
ISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 21150, Cosmetics — Microbiology — Detection of Escherichia coli
ISO 22717, Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa
ISO 22718, Cosmetics — Microbiology — Detection of Staphylococcus aureus
ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of
microbiologically low-risk products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 21148 and the following 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
aqueous toy material
toy material with a water activity of ≥0,5
Note 1 to entry: Water activity (denoted A ) is the partial vapour pressure of water in the toy material divided by
w
the vapour pressure of pure water at the same temperature. It is a measure of unbound water in the material and
is not necessarily the equivalent of moisture content.
3.2
aerobic mesophilic microorganisms
aerobic bacteria, yeast and mould with optimal growth at temperatures between 25 °C and 40 °C
3.3
infant product
product marketed for children under 36 months
3.4
total aerobic mesophilic count
TAMC
measure of aerobic mesophilic microorganism (3.2) formation on culture media
3.5
total yeast and mould count
TYMC
measure of yeast and mould colony formation on culture media under aerobic conditions
4 General
This document does not purport to cover or include every conceivable potential microbiological hazard
of a particular toy or toy category.
When conducting microbiological examinations for any product, it is especially important that:
— only those microorganisms which are present in the samples be isolated or enumerated;
— the microorganisms do not contaminate the environment.
In order to achieve this, it is necessary to pay attention to sanitation and hygiene and to use aseptic
techniques which ensure, as far as possible, exclusion of extraneous contamination.
Since, in this document, it is possible to give only a few examples of the precautions to be taken during
microbiological examinations, a thorough knowledge of the microbiological testing techniques and of
the microorganisms involved is essential. It is important that the analyses be conducted as accurately
as possible, including calculation of the number of microorganisms.
A large number of manipulations can, for example, unintentionally lead to cross-contamination and
the analyst should always verify the accuracy of the results given by their technique. It is necessary to
take special precautions, not only for reasons of hygiene but also to ensure good reproducibility of the
results.
Colony counts shall be performed in accordance with ISO 11930.
Powders intended to be mixed with water shall be tested after mixing; testing shall take into account
the effects of mixing variation of ± 10 % of water volume.
Annex A provides information regarding good manufacturing practice for process water.
5 Risk assessment
5.1 General
Prior to conducting microbiological testing, products shall be evaluated to determine if they are
susceptible to microbial growth. Pay particular attention to repeat-use products that are susceptible to
contamination by
...