SIST-TP CEN/TR 13387-1:2015
(Main)Child use and care articles - General safety guidelines - Part 1: Safety philosophy and safety assessment
Child use and care articles - General safety guidelines - Part 1: Safety philosophy and safety assessment
This Technical Report, contains the general safety philosophy and a guideline on safety assessment that experts are recommended to use when drafting standards.
It also contains an Annex (A) with a collection of available anthropometric data and details of the abilities of children from birth to 48 months of age.
The general safety philosophy given in this part is based on the principle that child use and care articles should be designed to be safe.
Children with special needs have not been taken into account while drafting these guidelines. ISO/IEC Guide 71 should be consulted to ascertain any further requirements to address the hazards and risks associated with children with special needs.
These guidelines do not cover all types of hazards and risks, such as inappropriate use of products, inadequate supervision of children and products used in a non-domestic situation.
Attention is drawn to the importance of ensuring that all other potential hazards relevant to the product are fully addressed e.g. hygiene, the effects of electrical power etc., where other safety standards may apply.
Articles de puériculture - Conseils relatifs à la sécurité - Partie 1 : Principes de sécurité et évaluation de la sécurité
Le présent Rapport technique contient les principes généraux de sécurité ainsi qu’un guide sur l’évaluation de la sécurité qu’il est recommandé aux experts d’utiliser lors de l’élaboration de normes.
Il comprend également une Annexe A avec un ensemble de données anthropométriques disponibles et de détails sur les capacités des enfants, de la naissance à l’âge de 48 mois.
Les principes généraux de sécurité donnés dans cette partie reposent sur le principe qu’il convient de concevoir les articles de puériculture de manière à ce qu’ils soient sûrs.
Les enfants ayant des besoins particuliers n’ont pas été pris en compte dans l’élaboration de ce guide. Il convient de consulter le Guide ISO/IEC 71 pour vérifier toute autre exigence visant à traiter les dangers et les risques associés aux enfants ayant des besoins particuliers.
Le présent guide ne couvre pas tous les types de dangers et de risques, tels qu’une utilisation inappropriée des produits, une surveillance inadéquate des enfants et l’usage des produits dans un cadre autre que domestique.
Il convient d’accorder une attention toute particulière à l’importance de s’assurer que tous les autres dangers potentiels relatifs au produit sont traités dans leur intégralité, par exemple l’hygiène, les effets du courant électrique, etc., lorsque d’autres normes de sécurité peuvent s’appliquer.
Izdelki za otroke - Smernice o splošni varnosti - 1. del: Filozofija in ocena varnosti
To tehnično poročilo zajema filozofijo splošne varnosti in smernice o oceni varnosti, ki se priporočajo strokovnjakom pri sestavljanju standardov.
Zajema tudi dodatek (A) z zbirko razpoložljivih antropometričnih podatkov in podrobnosti o sposobnosti otrok od rojstva do 48 mesecev starosti.
Filozofija splošne varnosti iz tega dela temelji na načelu, da naj bi bili izdelki za otroke zasnovani tako, da so varni.
Pri sestavi teh smernic niso bili upoštevani otroci s posebnimi potrebami. Vodilo ISO/IEC 71 naj bi se uporabilo za opredelitev morebitnih dodatnih zahtev za obravnavo nevarnosti in tveganj, povezanih z otroki s posebnimi potrebami.
Te smernice ne obravnavajo vseh vrst nevarnosti in tveganj, kot so neprimerna uporaba izdelkov, nezadosten nadzor nad otroki ter izdelki, ki se ne uporabljajo doma.
Opozoriti je treba na pomembnost zagotavljanja, da so vse druge morebitne nevarnosti, ki se nanašajo na izdelek, v celoti obravnavane, npr. higiena, vplivi električnega toka itd., pri čemer se lahko uporabljajo drugi varnostni standardi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 13387-1:2015
01-oktober-2015
1DGRPHãþD
SIST-TP CEN/TR 13387:2005
Izdelki za otroke - Smernice o splošni varnosti - 1. del: Filozofija in ocena varnosti
Child use and care articles - General safety guidelines - Part 1: Safety philosophy and
safety assessment
Ta slovenski standard je istoveten z: CEN/TR 13387-1:2015
ICS:
97.190 Otroška oprema Equipment for children
SIST-TP CEN/TR 13387-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 13387-1:2015
TECHNICAL REPORT
CEN/TR 13387-1
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2015
ICS 97.190 Supersedes CEN/TR 13387:2004
English Version
Child use and care articles - General safety guidelines - Part 1:
Safety philosophy and safety assessment
This Technical Report was approved by CEN on 12 January 2015. It has been drawn up by the Technical Committee CEN/TC 252.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13387-1:2015 E
worldwide for CEN national Members.
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CEN/TR 13387-1:2015 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 General safety . 6
3 Terms and definitions . 7
4 Accident data . 8
5 Hazard and risk assessment . 8
5.1 Introduction . 8
5.2 Methodology . 8
Annex A (informative) Anthropometric data and abilities of children from birth to 48
months . 16
A.1 General . 16
A.2 Terms and definitions related to anthropometric data . 16
A.3 Recommendations for use of data . 17
A.4 Applications . 19
A.4.1 Accessibility . 19
A.4.2 Openings . 19
A.4.3 Structural integrity . 19
A.5 Tables with body dimensions . 20
A.6 Tables with force measurements . 28
A.7 Abilities of children . 30
A.8 Sources of data . 30
Bibliography . 33
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European foreword
This document (CEN/TR 13387-1:2015) has been prepared by Technical Committee CEN/TC 252
“Child use and care articles”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such
patent rights.
This document supersedes CEN/TR 13387:2004.
CEN/TR 13387 comprises the following five parts:
— Safety philosophy and safety assessment (CEN/TR 13387-1);
— Chemical hazards (CEN/TR 13387-2);
— Mechanical hazards (CEN/TR 13387-3);
— Thermal hazards (CEN/TR 13387-4);
— Product information (CEN/TR 13387-5).
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Introduction
This is a revision of CR 13387 first published in 1999. It is a non-normative CEN publication which
provides guidance information on common hazards that should be taken into consideration when
developing safety standards for child use and care articles.
A general safety philosophy and safety assessment methodology is given in Part 1 of these guidelines
together with a collection of anthropometric data.
Chemical hazards are addressed in Part 2. The chemical risk associated with the use of materials for
the construction, coating and/or packaging of child use and care articles that may affect children’s
health are considered.
Mechanical hazards are addressed in Part 3. “Mechanical hazard” is a general designation for physical
factors which may give rise to injury due to the mechanical properties of products or parts of products.
Thermal hazards are addressed in Part 4. “Thermal hazards” include hazards associated with
flammability and the burning characteristics of materials, contact with hot and cold surfaces, liquids
and food, contact with flames, contact with products that melt on heating and overheating or exposure
of a child to very low and very high temperatures.
Product information which should be supplied with a child use and care article is addressed in Part 5.
“Product information” covers all the documentation and information that should be supplied to ensure
the safe use of the product and also the safety of the child using the product.
These guidelines deal with hazards that are common to child use and care articles. They have been
drawn-up by a working group of experts set up by CEN TC 252 with the prime objective of
harmonizing the approach to hazard and risk assessment and injury prevention. The guidelines give
recommendations on preventive safety measures to avoid injuries that could be caused by child use
and care articles. If the child use and care article has a protective function, this has to be effective;
additionally the product itself has to cause no injury to the child.
The standards being drafted by CEN/TC 252 are for child use and care articles intended for children
from birth to 48 months of age who form a very vulnerable group in society. Up to 18 months of age
the development of knowledge takes place through the combined use of sensory and motor skills, i.e.
children learn to see, hear, taste, smell and feel. Their movements are aimed at achieving familiarity
with their environment. As children become older they achieve increased muscular control and
balance. Even up to 48 months of age children are unpredictable in their behaviour. Special
consideration has to be given to the fact that these children cannot understand how to avoid risks and
thus are involuntarily exposed to them.
Child use and care articles constitute a group with large variations between the different products.
However many safety hazards associated with this diverse group of products are very similar. These
guidelines identify many of these safety hazards and give details that enable similar safety principles
to be applied to the drafting of standards across the group of products.
The information given in these guidelines reflects the state of the art at publication. Standards and
regulations will continuously be developed. Other sources may also provide useful information for the
reader.
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How to use these guidelines
The safety requirements and test methods given are intended to give guidance and to lead to
consistency when writing safety standards for child use and care articles. It is recommended to use
these guidelines when drafting standards.
In addition, these guidelines can assist those with a general professional interest in child safety.
The safety requirements detailed do not constitute an exhaustive set that can be applied to all child
use and care articles. The application to particular products should be evaluated by experts.
In these guidelines rationales are given to explain the potential hazard. Wherever possible,
requirements, test equipment and test methods are given which can be used when drafting standards.
The terminology in these guidelines is not the one required for standards:, the word 'shall' has to be
used in standards, not 'should' as given in these guidelines.
CEN/TC 252 is, wherever possible when writing new standards or revising existing standards, drafting
their standards on a hazard based format (see for example EN 16120:2012+A1:2014 and
EN 1930:2011).
The different parts of the CEN/TR 13387 should enable working groups to draft their standards in a
hazard based format by proceeding in the following way:
— identification of the hazards and assessment of the risk;
— definition of the requirements to address an identified hazard and risk;
— definition of relevant test methods to check that the requirements are met;
— provision of an Annex which indicates the rationale for the inclusion of the requirements.
5
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1 Scope
This Technical Report, contains the general safety philosophy and a guideline on safety assessment
that experts are recommended to use when drafting standards.
It also contains an Annex A with a collection of available anthropometric data and details of the
abilities of children from birth to 48 months of age.
The general safety philosophy given in this part is based on the principle that child use and care
articles should be designed to be safe.
Children with special needs have not been taken into account while drafting these guidelines.
ISO/IEC Guide 71 should be consulted to ascertain any further requirements to address the hazards
and risks associated with children with special needs.
These guidelines do not cover all types of hazards and risks, such as inappropriate use of products,
inadequate supervision of children and products used in a non-domestic situation.
Attention is drawn to the importance of ensuring that all other potential hazards relevant to the product
are fully addressed e.g. hygiene, the effects of electrical power etc., where other safety standards may
apply.
2 General safety
Safety is often a balance between being safe from injury and the other demands of a child use and
care article, for example, ensuring that the item is fit for purpose as well as meeting consumers’ needs
and expectations.
Attention should be paid to:
— the child’s stage of development (ability, weight, age, etc.);
— the intended or foreseeable use of the product, bearing in mind a child’s unpredictable behaviour.
This unpredictable behaviour exposes children to injury in ways that differ from those of adults,
making children a particularly vulnerable group in society;
— the hazard presented by the product in the environment where the product is used.
Child use and care articles should be designed to be safe. Hazards should be eliminated wherever
possible. For cases where a hazard cannot be eliminated or sufficiently minimized – by design or
safeguards – product related information should be given. However product related information should
not be used as an alternative to safe design.
Where the function of a product or part of a product changes by virtue of its use and is beyond the
scope of child use and care articles, appropriate requirements should be applied. An example may be
a high chair that can be converted into a normal chair.
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3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
harm
injury or damage to the health of people, or damage to property or the environment
3.2
hazard
potential source of harm
3.3
risk
combination of the probability of occurrence of harm and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation, the occurrence
of a hazardous event, and the possibility to avoid or limit the harm.
3.4
hazard characterisation
quantitative evaluation of the nature of the adverse health effects following exposure to a risk
source(s)
3.5
hazard identification
identification of a risk source(s) capable of causing adverse effect(s)
3.6
risk analysis
systematic use of available information to identify hazards and to estimate the risk
3.7
risk evaluation
procedure based on the risk analysis to determine whether tolerable risk has been exceeded
3.8
risk assessment
overall process comprising a risk analysis and a risk evaluation
Note 1 to entry: In practical terms this means the evaluation, including the identification of the related
uncertainties, of the likelihood and severity of an adverse effect(s) following exposure under defined means to a
risk source(s).
3.9
safety
freedom from risk which is not tolerable
3.10
intended use
use in accordance with information provided together with a product or system, or, in the absence of
such information, by generally understood patterns of usage
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4 Accident data
Available accident and injury data should be consulted. The absence of an accident history cannot be
a good reason for an automatic presumption of a low level of risk. Other factors should be taken into
account, particularly when the possible severity of injury is high.
Appropriate data may not be available for many reasons, including the absence or ineffectiveness of a
data collection system, the time delay in collating and presenting statistics, changes in product design
and use conditions etc. For example, historical information related to a product or material used in a
hot climate may not apply to its use in colder countries or vice versa.
5 Hazard and risk assessment
5.1 Introduction
The approach to hazard risk assessment described in this clause should ensure that the major
hazards are assessed when considering child safety within standards.
This clause details a process to identify non-chemical hazards and to assess the risks of injury to
children associated with child use and care articles. The assessment of chemical hazards and risks is
included in CEN/TR 13387-2.
When developing a new child use and care article safety standard or revising an existing one or
working with a standard where child safety needs to be addressed, it is necessary to conduct a hazard
and risk assessment. This involves gathering together information from a variety of sources such as
accident data, RAPEX and recall notifications, expert opinion and other reliable sources of information.
Additionally, reference should be made to relevant child safety guidelines, publications and safety
standards.
The hazard risk assessment methodology described in this clause is intended to be used during
development or revision of standards; it is not designed to be used solely during product development
or for assessment of products on the market.
5.2 Methodology
Separate hazard and risk assessment tables are provided for mechanical hazards, thermal hazards
and other non-chemical hazards.
All three tables list the known hazards that have been identified through review of available guides and
standards. Additional hazards not listed in the tables may be associated with certain product
categories and should also be considered.
Before the hazard and risk assessment tables can be completed, all available data, such as accident
data, RAPEX and recall notifications, expert opinion and other reliable sources of information require
analysis. There is also a need to fully review the products available and to understand how children
will interact with the product. It is also necessary to understand the type of injuries that can occur and
how they are caused, as well as how accidents themselves occur and the likely outcomes.
Each table contains the same headings which are explained below:
— The hazard list, based on CEN/TR 13387-3, CEN/TR 13387-4, CEN Guide 12 and
ISO/IEC Guide 50.
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— The hazard identification column utilizes available accident data, RAPEX and recall notifications,
reported incidents, expert opinion and other reliable sources of information to identify the hazards
associated with a product.
— The hazard analysis column indicates the worst-case scenario should an accident occur with the
indicated hazard.
— The risk level column indicates the level of risk.
— The risk management measures column identifies those hazards addressed in other similar safety
standards, as well as providing the following three options for dealing with the hazard:
— include safety requirements to address the hazard; or
— include product information to address the hazard; or
— there is no need to address the hazard.
The decision on which option should be taken is based on the information entered in the row and
whether or not the hazard is considered a high, medium or low risk.
Hazards resulting in high or medium risk should be addressed within the standard by safety
requirements. Hazards resulting in low risk should be addressed in the standard by safety
requirements, providing they do not conflict with the requirements for high or medium risk. Product
information should be used to address any hazard that cannot be suitably addressed by safety
requirements.
— The comments column is used to explain the rationale and considerations for the decisions
indicated in the table and should be systematically filled in for each item in the tables.
Once all the relevant data has been analysed it should be easy to complete the relevant hazard risk
analysis table by placing an indication in the relevant boxes. With all the relevant boxes completed in
each row of each table it should be possible to draw a conclusion on the level of risk involved with the
hazard, as well as what action is needed to address the hazard in the safety standard.
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Table 1 — Mechanical hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards from gaps and
openings:
- Entrapment of head and
neck
- Entrapment of fingers
- Entrapment of limbs
Hazards due to moving
parts, i.e. shearing and
compression
Hazards due to crushing
Hazards due to protrusions
Entanglement in cords,
ribbons and parts used as
ties
Ingestion hazards
10
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Choking hazards
Hazards from plastic decals
or sheeting
Hazards from packaging
materials
Hazardous edges
Hazardous points and wire
Hazards from inadequate
stability
Hazards from inadequate
structural integrity
Hazards from inadequate
protective barrier function
Hazards from inadequate
protective restraint systems
Falling hazards due to
footholds
11
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards due to inadequate
size
Hazards due to inadvertent
release of attachment
mechanisms
12
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 2 — Thermal hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards due to flash effect
Hazards due to flame
propagation
Hazards from the melting
behaviour of materials
Hazards from contact with
flames
Hazards from hot and cold
surfaces
Hazards from hot and cold
liquids and food
Hypothermia and
hyperthermia hazards
13
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 3 — Other non-chemical hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Suffocation hazards due to
an enclosed space
Hazardous heights (falls)
Hazards from moving or
rotating objects
Hazards from noise
Drowning hazards
Hazards from suction, i.e.
suction cups
Electric shock hazards
Radiation hazards
High intensity or
concentrated light
Biological hazards
14
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Explosion hazards
Inadequate protective
function
Inadequate information
15
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious and reversible or minor
and irreversible injuries
Serious and irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Annex A
(informative)
Anthropometric data and abilities of children from birth to 48 months
A.1 General
This annex provides tables of anthropometric data and abilities of children from birth to 48 months related to
risks. It presents a compilation of data available in current literature. Only sources that explain the method by
which the measurements were taken, and of which the sample size was large enough to give reliable results
have been selected.
Because the difference between European populations is relatively small for children up to 48 months, only
one source for each measurement has been used.
NOTE 1 The European populations are fairly homogenous (Eveleth and Tanner 1990). At 12 months the maximum
difference in mean of length of boys is 3 cm. At 48 months this is about 3,5 cm. The maximum difference in mean of
weight is 0,8 kg at 12 months, and 1,6 kg at 48 months. These differences are small compared to the ones within one age
group.
NOTE 2 This annex provides an overview of data sources available at the time of publication of CEN/TR 13387–
1:2015. The listed data may not represent the data of the actual European population, but can be taken as reference when
defining safety requirements.
If possible the mean value, standard deviation, the 5th and the 95th percentile are given.
When these data are used in safety requirements a safety margin should be included. This safety margin
depends on the required safety level.
The data given in the tables are taken from different publications listed in A.8.
Additional data can be obtained from the report: CHILDATA, the handbook of Child Measurements and
Capabilities (Consumer Safety Unit, Department of Trade and Industry, UK). This document gives an overview
of the most important data sources for child safety.
A.2 Terms and definitions related to anthropometric data
A.2.1
standard deviation (sd)
parameter of the normal distribution used to indicate the amount of variance in an attribute. Approximately
68 % of a population will lie within the mean ± 1 × sd
A.2.2
5th percentile (P5)
value of a normal distributed variable which covers the smallest 5 % of the popula
...
SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 13387-1:2014
01-december-2014
Smernice o splošni varnosti - 1. del: Filozofija in ocena varnosti
General safety guidelines - Part 1: Safety philosophy and safety assessment
Ta slovenski standard je istoveten z: FprCEN/TR 13387-1
ICS:
97.190 Otroška oprema Equipment for children
kSIST-TP FprCEN/TR 13387-1:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TP FprCEN/TR 13387-1:2014
TECHNICAL REPORT
FINAL DRAFT
FprCEN/TR 13387-1
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2014
ICS 97.190 Will supersede CEN/TR 13387:2004
English Version
General safety guidelines - Part 1: Safety philosophy and safety
assessment
This draft Technical Report is submitted to CEN members for Technical Committee Approval. It has been drawn up by the Technical
Committee CEN/TC 252.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
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.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 13387-1:2014 E
worldwide for CEN national Members.
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Contents
Page
Foreword .3
Introduction .4
1 Scope .6
2 General safety .6
3 Terms and definitions .6
4 Accident data .7
5 Hazard and risk assessment .8
5.1 Introduction .8
5.2 Methodology .8
Annex A Anthropometric data and abilities of children from birth to 48 months . 18
A.1 General . 18
A.2 Terms and definitions related to anthropometric data . 18
A.3 Recommendations for use of data . 18
A.4 Applications . 21
A.4.1 Accessibility . 21
A.4.2 Openings . 21
A.4.3 Structural integrity . 21
A.5 Tables with body dimensions . 22
A.6 Tables with force measurements . 31
A.7 Abilities of children. 33
A.8 Sources of data . 34
Bibliography . 37
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Foreword
This document (FprCEN/TR 13387-1:2014) has been prepared by Technical Committee CEN/TC 252 “Child use
and care articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Technical Committee Approval.
This document will supersede CEN/TR 13387:2004.
FprCEN/TR 13387 comprises the following five parts:
Safety philosophy and safety assessment (FprCEN/TR 13387-1)
Chemical hazards (FprCEN/TR 13387-2)
Mechanical hazards (FprCEN/TR 13387-3)
Thermal hazards (FprCEN/TR 13387-4)
Product information (FprCEN/TR 13387-5)
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Introduction
This is a revision of CR 13387 first published in 1999. It is a non-normative CEN publication which
provides guidance information on common hazards that should be taken into consideration when
developing safety standards for child use and care articles.
TR 13387 comprises the following five parts:
Safety philosophy and safety assessment (TR 13387-1), which is designed to be used with Parts
2-5
Chemical hazards (TR 13387-2)
Mechanical hazards (TR 13387-3)
Thermal hazards (TR 13387-4)
Product information (TR 13387-5)
A general safety philosophy and safety assessment methodology is given in Part 1 of these guidelines
together with a collection of anthropometric data.
Chemical hazards are addressed in Part 2. The chemical risk associated with the use of materials for
the construction, coating and/or packaging of child use and care articles that may affect children’s
health are considered.
Mechanical hazards are addressed in Part 3. “Mechanical hazard” is a general designation for physical
factors which may give rise to injury due to the mechanical properties of products or parts of products.
Thermal hazards are addressed in Part 4. “Thermal hazards” include hazards associated with
flammability and the burning characteristics of materials, contact with hot and cold surfaces, liquids
and food, contact with flames, contact with products that melt on heating and overheating or exposure
of a child to very low and very high temperatures.
Product information which should be supplied with a child use and care article is addressed in Part 5.
“Product information” covers all the documentation and information that should be supplied to ensure
the safe use of the product and also the safety of the child using the product.
These guidelines deal with hazards that are common to child use and care articles. They have been
drawn-up by a working group of experts set up by CEN TC 252 with the prime objective of
harmonizing the approach to hazard and risk assessment and injury prevention. The guidelines give
recommendations on preventive safety measures to avoid injuries that could be caused by child use
and care articles. If the child use and care article has a protective function, this must be effective;
additionally the product itself must not cause injury to the child.
The standards being drafted by CEN/TC 252 are for child use and care articles intended for children
from birth to 48 months of age who form a very vulnerable group in society. Up to 18 months of age
the development of knowledge takes place through the combined use of sensory and motor skills, i.e.
children learn to see, hear, taste, smell and feel. Their movements are aimed at achieving familiarity
with their environment. As children become older they achieve increased muscular control and
balance. Even up to 48 months of age children are unpredictable in their behaviour. Special
consideration has to be given to the fact that these children cannot understand how to avoid risks and
thus are involuntarily exposed to them.
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Child use and care articles constitute a group with large variations between the different products.
However many safety hazards associated with this diverse group of products are very similar. These
guidelines identify many of these safety hazards and give details that enable similar safety principles
to be applied to the drafting of standards across the group of products.
The information given in these guidelines reflects the state of the art at publication. Standards and
regulations will continuously be developed. Other sources may also provide useful information for the
reader.
How to use these guidelines
The safety requirements and test methods given are intended to give guidance and to lead to
consistency when writing safety standards for child use and care articles. It is recommended to use
these guidelines when drafting standards.
In addition, these guidelines can assist those with a general professional interest in child safety.
The safety requirements detailed do not constitute an exhaustive set that can be applied to all child
use and care articles. The application to particular products should be evaluated by experts.
In these guidelines rationales are given to explain the potential hazard. Wherever possible,
requirements, test equipment and test methods are given which can be used when drafting standards.
The terminology in these guidelines is not the one required for standards:, the word 'shall' has to be
used in standards, not 'should' as given in these guidelines.
CEN TC 252 is, wherever possible when writing new standards or revising existing standards, drafting
their standards on a hazard based format (see for example EN 16120:2012 and EN 1930:2011).
The different parts of the TR 13387 should enable working groups to draft their standards in a hazard
based format by proceeding in the following way:
identification of the hazards and assessment of the risk;
definition of the requirements to address an identified hazard and risk;
definition of relevant test methods to check that the requirements are met;
provision of an Annex which indicates the rationale for the inclusion of the requirements.
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1 Scope
This Technical Report, contains the general safety philosophy and a guideline on safety assessment
that experts are recommended to use when drafting standards.
It also contains an Annex (A) with a collection of available anthropometric data and details of the
abilities of children from birth to 48 months of age.
The general safety philosophy given in this part is based on the principle that child use and care
articles should be designed to be safe.
Children with special needs have not been taken into account while drafting these guidelines. ISO/IEC
Guide 71 should be consulted to ascertain any further requirements to address the hazards and risks
associated with children with special needs.
These guidelines do not cover all types of hazards and risks, such as inappropriate use of products,
inadequate supervision of children and products used in a non-domestic situation.
Attention is drawn to the importance of ensuring that all other potential hazards relevant to the product
are fully addressed e.g. hygiene, the effects of electrical power etc., where other safety standards may
apply.
2 General safety
Safety is often a balance between being safe from injury and the other demands of a child use and
care article, for example, ensuring that the item is fit for purpose as well as meeting consumers’ needs
and expectations.
Attention should be paid to:
the child’s stage of development (ability, weight, age, etc.);
the intended or foreseeable use of the product, bearing in mind a child’s unpredictable behaviour.
This unpredictable behaviour exposes children to injury in ways that differ from those of adults,
making children a particularly vulnerable group in society;
the hazard presented by the product in the environment where the product is used.
Child use and care articles should be designed to be safe. Hazards should be eliminated wherever
possible. For cases where a hazard cannot be eliminated or sufficiently minimized – by design or
safeguards – product related information should be given. However product related information should
not be used as an alternative to safe design.
Where the function of a product or part of a product changes by virtue of its use and is beyond the
scope of child use and care articles, appropriate requirements should be applied. An example may be
a high chair that can be converted into a normal chair.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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3.1
harm
injury or damage to the health of people, or damage to property or the environment
3.2
hazard
potential source of harm
3.3
risk
combination of the probability of occurrence of harm and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation, the occurrence
of a hazardous event, and the possibility to avoid or limit the harm.
3.4
hazard characterisation
quantitative evaluation of the nature of the adverse health effects following exposure to a risk
source(s).
3.5
hazard identification
identification of a risk source(s) capable of causing adverse effect(s)
3.6
risk analysis
systematic use of available information to identify hazards and to estimate the risk
3.7
risk evaluation
procedure based on the risk analysis to determine whether tolerable risk has been exceeded
3.8
risk assessment
overall process comprising a risk analysis and a risk evaluation
Note 1 to entry: In practical terms this means the evaluation, including the identification of the related
uncertainties, of the likelihood and severity of an adverse effect(s) following exposure under defined means to a
risk source(s).
3.9
safety
freedom from risk which is not tolerable
3.10
intended use
use in accordance with information provided together with a product or system, or, in the absence of
such information, by generally understood patterns of usage
4 Accident data
Available accident and injury data should be consulted. The absence of an accident history cannot be
a good reason for an automatic presumption of a low level of risk. Other factors should be taken into
account, particularly when the possible severity of injury is high.
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Appropriate data may not be available for many reasons, including the absence or ineffectiveness of a
data collection system, the time delay in collating and presenting statistics, changes in product design
and use conditions etc. For example, historical information related to a product or material used in a
hot climate may not apply to its use in colder countries or vice versa.
5 Hazard and risk assessment
5.1 Introduction
The approach to hazard risk assessment described in this clause should ensure that the major
hazards are assessed when considering child safety within standards.
This clause details a process to identify non-chemical hazards and to assess the risks of injury to
children associated with child use and care articles. The assessment of chemical hazards and risks is
included in CEN/TR 13387-2.
When developing a new child use and care article safety standard or revising an existing one or
working with a standard where child safety needs to be addressed, it is necessary to conduct a hazard
and risk assessment. This involves gathering together information from a variety of sources such as
accident data, RAPEX and recall notifications, expert opinion and other reliable sources of information.
Additionally, reference should be made to relevant child safety guidelines, publications and safety
standards.
5.2 Methodology
Separate hazard and risk assessment tables are provided for mechanical hazards, thermal hazards
and other non-chemical hazards.
All three tables list the known hazards that have been identified through review of available guides and
standards. Additional hazards not listed in the tables may be associated with certain product
categories and should also be considered.
Before the hazard and risk assessment tables can be completed, all available data, such as accident
data, RAPEX and recall notifications, expert opinion and other reliable sources of information require
analysis. There is also a need to fully review the products available and to understand how children
will interact with the product. It is also necessary to understand the type of injuries that can occur and
how they are caused, as well as how accidents themselves occur and the likely outcomes.
Each table contains the same headings which are explained below:
The hazard list, based on CEN/TR 13387-3, CEN/TR 13387-4, CEN Guide 12 and ISO/IEC Guide
50.
The hazard identification column utilises available accident data, RAPEX and recall notifications,
reported incidents, expert opinion and other reliable sources of information to identify the hazards
associated with a product.
The hazard analysis column indicates the worst-case scenario should an accident occur with the
indicated hazard.
The risk level column indicates the level of risk.
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The risk management measures column identifies those hazards addressed in other similar safety
standards, as well as providing the following three options for dealing with the hazard:
include safety requirements to address the hazard; or
include product information to address the hazard; or
there is no need to address the hazard.
The decision on which option should be taken is based on the information entered in the row and
whether or not the hazard is considered a high, medium or low risk.
Hazards resulting in high or medium risk should be addressed within the standard by safety
requirements. Hazards resulting in low risk should be addressed in the standard by safety
requirements, providing they do not conflict with the requirements for high or medium risk. Product
information should be used to address any hazard that cannot be suitably addressed by safety
requirements.
The comments column is used to explain the rationale and considerations for the decisions
indicated in the table and should be systematically filled in for each item in the tables.
Once all the relevant data has been analysed it should be easy to complete the relevant hazard risk
analysis table by placing an indication in the relevant boxes. With all the relevant boxes completed in
each row of each table it should be possible to draw a conclusion on the level of risk involved with the
hazard, as well as what action is needed to address the hazard in the safety standard.
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Table 1 — Mechanical hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards from gaps and
openings:
- Entrapment of head and
neck
- Entrapment of fingers
- Entrapment of limbs
Hazards due to moving
parts, i.e. shearing and
compression
Hazards due to crushing
Hazards due to protrusions
Entanglement in cords,
ribbons and parts used as
ties
10
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Ingestion hazards
Table 1 (continued)
Hazard list Hazard identification Hazard analysis Risk Risk management Comments
level measures
11
Accident data Accident data
RAPEX RAPEX
Recalls Recalls
Reported incidents Reported incidents
Product reports Product reports
Expert opinion Expert opinion
Minor or reversible injuries Minor or reversible injuries
Serious & reversible or minor & Serious & reversible or minor &
irreversible injuries irreversible injuries
Serious & irreversible injuries
Serious & irreversible injuries
Death
Death
L (Low) – M (Medium) – H (High) L (Low) – M (Medium) – H (High)
Hazard addressed by another Hazard addressed by another
similar safety standard or a similar safety standard or a
previous version previous version
Hazard to be addressed by
Hazard to be addressed by
safety requirements
safety requirements
Hazard to be addressed by
Hazard to be addressed by
product information
product information
Hazard not to be addressed
Hazard not to be addressed
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Hazard list Hazard identification Hazard analysis Risk Risk management Comments
level measures
Choking hazards
Hazards from plastic decals
or sheeting
Hazards from packaging
materials
Hazardous edges
Hazardous points and wire
Hazards from inadequate
stability
Hazards from inadequate
structural integrity
12
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 1 (continued)
Hazard list Hazard identification Hazard analysis Risk Risk management Comments
level measures
Hazards from inadequate
protective barrier function
Hazards from inadequate
protective restraint systems
Falling hazards due to
footholds
Hazards due to inadequate
size
Hazards due to inadvertent
release of attachment
mechanisms
13
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 2 — Thermal hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards due to flash effect
Hazards due to flame
propagation
Hazards from the melting
behaviour of materials
Hazards from contact with
flames
Hazards from hot and cold
surfaces
14
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 2 (continued)
Risk
Hazard list Hazard identification Hazard analysis Risk management measures Comments
level
Hazards from hot and cold
liquids and food
Hypothermia and
hyperthermia hazards
15
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
previous version
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 3 — Other non-chemical hazards
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Suffocation hazards due to
an enclosed space
Hazardous heights (falls)
Hazards from moving or
rotating objects
Hazards from noise
Drowning hazards
16
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Table 3 (continued)
Risk Risk management
Hazard list Hazard identification Hazard analysis Comments
level measures
Hazards from suction, i.e.
suction cups
Electric shock hazards
Radiation hazards
High intensity or
concentrated light
Biological hazards
Explosion hazards
Inadequate protective
function
Inadequate information
17
Accident data
RAPEX
Recalls
Reported incidents
Product reports
Expert opinion
Minor or reversible injuries
Serious & reversible or minor &
irreversible injuries
Serious & irreversible injuries
Death
L (Low) – M (Medium) – H (High)
Hazard addressed by another
similar safety standard or a
Hazard to be addressed by
safety requirements
Hazard to be addressed by
product information
Hazard not to be addressed
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Annex A
Anthropometric data and abilities of children from birth to 48 months
A.1 General
This Annex provides tables of anthropometric data and abilities of children from birth to 48 months related to
risks. It presents a compilation of data available in current literature. Only sources that explain the method by
which the measurements were taken, and of which the sample size was large enough to give reliable results
have been selected.
Because the difference between European populations is relatively small for children up to 48 months, only
one source for each measurement has been used.
NOTE The European populations are fairly homogenous (Eveleth and Tanner 1990). At 12 months the maximum
difference in mean of len
...
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