SIST-TP CEN/TR 13387-1:2015

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

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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


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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
...