ISO 8124-12:2023
(Main)Safety of toys — Part 12: Microbiological safety
Safety of toys — Part 12: Microbiological safety
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.
Sécurité des jouets — Partie 12: Sécurité microbiologique
General Information
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Standards Content (Sample)
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 8124-12:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 8124-12:2023(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
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8124-12:2023(E)
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
© ISO 2023 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 8124-12:2023(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 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 181, Safety of toys.
A list of all parts in the ISO 8124 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
© ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8124-12:2023(E)
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
© ISO 2023 – All rights reserved
---------------------- Page: 5 ----------------------
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
1
© ISO 2023 – All rights reserved
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ISO 8124-12:2023(E)
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, Co
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8124-12
ISO/TC 181 Secretariat: DS
Voting begins on: Voting terminates on:
2022-07-11 2022-10-03
Safety of toys —
Part 12:
Microbiological Safety
ICS: 97.200.50; 07.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8124-12:2022(E)
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. © ISO 2022
---------------------- Page: 1 ----------------------
ISO/DIS 8124-12:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8124-12
ISO/TC 181 Secretariat: DS
Voting begins on: Voting terminates on:
Safety of toys —
Part 12:
Microbiological Safety
ICS: 97.200.50; 07.100.99
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 8124-12:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
---------------------- Page: 2 ----------------------
ISO/DIS 8124-12:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General . 3
5 Microbiological cleanliness .3
5.1 General . 3
5.2 Aqueous toy materials . 3
6 Risk assessment . 4
6.1 General . 4
6.2 Evaluation . 4
6.3 Exception for testing . 5
7 Microbiological challenge (preservation effectiveness) . 5
8 Test procedures . 5
8.1 General requirements . 5
8.2 Microbiological cleanliness . 5
8.3 Preservation effectiveness . 6
Annex A (informative) Process water . 7
Bibliography . 8
iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/DIS 8124-12:2022(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 181, Safety of Toys.
This is the first edition of the document.
Safety of Toys — Part 12: Microbiological Safety
A list of all parts in the ISO 8124 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
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 8124-12:2022(E)
Introduction
This document is largely based upon existing requirements in the United States of America toy safety
standard, ASTM F963, with some modifications to narrow the scope and facilitate use of the standard
in multiple jurisdictions.
However, it should not be construed that a toy manufactured in compliance 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.
Compliance with the requirements of this document will minimize potential hazards associated with
toys resulting from their use in their 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. In addition, this document will not eliminate the need for parental supervision
in situations where children of various ages may have access to the same toy(s).
v
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 8124-12:2022(E)
Safety of toys —
Part 12:
Microbiological Safety
1 Scope
The requirements in this document apply to all products that are or contain materials which are
aqueous in nature, supplied as or with a toy or that are or include a cosmetic (including those intended
for use on a toy as well as on the child), paste, putty, powder, liquid, or gel that is aqueous in nature.
Powders and similar substances intended to be mixed with water by the child are also in scope for
microbiological cleanliness and are to be tested before and after mixing; such items are in scope for
microbiological challenge only if they are intended for repeated use and will be stored between play
sessions (manufacturers should consider the potential effect of variations in mixing proportions). 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 standard are inappropriate to apply to products
that are consumer complaint returns, as there is no way to establish what conditions the toys may have
been subject to before being returned. Toys in which the aqueous materials are contained so that there
is no accessibility either before or after use-and-abuse testing are exempt from these requirements.
The requirements of this document specify acceptable criteria for microbiological cleanliness and
adequacy of preservation of toy materials within the scope.
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 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 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 c
...
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