Writing and marking instruments -- Specification for caps to reduce the risk of asphyxiation

This document specifies requirements to reduce the risk of asphyxiation from caps for writing and marking instruments. It relates to such instruments which in normal or foreseeable circumstances are likely to be used by children up to the age of 14 years. This document is not applicable to the following: —   writing and marking instruments which are designed or only intended for use by adults, e.g. jewellery pens, expensive fountain pens, professional technical pens; —   transit caps for refills.

Instruments pour l'écriture et le marquage -- Spécifications pour les capuchons afin de réduire le risque d'asphyxie

General Information

Status
Published
Publication Date
02-Aug-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
26-Jun-2021
Completion Date
25-Jun-2021
Ref Project

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INTERNATIONAL ISO
STANDARD 11540
Third edition
2021-08
Writing and marking instruments —
Specification for caps to reduce the
risk of asphyxiation
Instruments pour l'écriture et le marquage — Spécifications pour les
capuchons afin de réduire le risque d'asphyxie
Reference number
ISO 11540:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 11540:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 11540:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Cap size .......................................................................................................................................................................................................... 1

4.3 Ventilated caps air flow ................................................................................................................................................................... 2

4.4 Test report ................................................................................................................................................................................................... 2

5 Identification ............................................................................................................................................................................................................ 3

Annex A (normative) Test for air flow ................................................................................................................................................................. 4

Annex B (informative) Design guidance for pen caps vent area .............................................................................................. 6

Bibliography ................................................................................................................................................................................................................................ 7

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 11540:2021(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 10, Technical product documentation.

This third edition cancels and replaces the second edition (ISO 11540:2014), of which it constitutes a

minor revision. The changes to the previous edition are as follows:

— Clause 2, Normative references, has been introduced and the clause numbering changed accordingly;

— In A.3.2 the reference to A.3.3 has been corrected to A.3.1;
— NOTE 1 and NOTE 2 have been deleted from Figure B.1;
— minor editorial changes.

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 11540:2021(E)
Introduction

If a child inhales a pen cap it might become lodged below the larynx and block the trachea. The risk of

asphyxiation can be reduced if the pen cap is ventilated or too large to enter the airway. Children must

be actively discouraged from sucking, chewing or putting pen caps in their mouths. A way of avoiding

the risk of inhalation of caps of writing and marking instruments is to manufacture products without

caps whenever possible. However, if caps are essential, the provisions of this document minimize risk

by specifying the design and performance of ventilated caps, which reduce the likelihood of inhalation

and delay asphyxiation pending medical intervention.

ISO/TC 10 recognizes that while it is possible to identify the age range of the children who are most

at risk, it is not possible to identify with certainty any writing instruments with detachable caps that

would never be accessible to children and hence never pose a risk. It is, however, acknowledged that

certain products (i.e. writing and marking instruments which are designed or only intended for use by

adults, e.g. jewellery pens, expensive fountain pens, professional technical pens)

...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11540
ISO/TC 10
Writing and marking instruments —
Secretariat: SIS
Specification for caps to reduce the
Voting begins on:
2021­04­30 risk of asphyxiation
Voting terminates on:
Instruments pour l'écriture et le marquage — Spécifications pour les
2021­06­25
capuchons afin de réduire le risque d'asphyxie
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 11540:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 11540:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 11540:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Cap size .......................................................................................................................................................................................................... 1

4.3 Ventilated caps air flow ................................................................................................................................................................... 2

4.4 Test report ................................................................................................................................................................................................... 2

5 Identification ............................................................................................................................................................................................................ 3

Annex A (normative) Test for air flow ................................................................................................................................................................. 4

Annex B (informative) Design guidance for pen caps vent area .............................................................................................. 6

Bibliography ................................................................................................................................................................................................................................ 7

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 11540:2021(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 non­governmental, 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 10, Technical product documentation.

This third edition cancels and replaces the second (ISO 11540:2014), of which it constitutes a minor

revision. The changes to the previous edition are as follows:

— Clause 2, Normative references, has been introduced and the clause numbering changed accordingly;

— In A.3.2 the reference to A.3.3 has been corrected to A.3.1;
— NOTE 1 and NOTE 2 have been deleted from Figure B.1;
— minor editorial changes.

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 11540:2021(E)
Introduction

If a child inhales a pen cap it might become lodged below the larynx and block the trachea. The risk of

asphyxiation can be reduced if the pen cap is ventilated or too large to enter the airway. Children must

be actively discouraged from sucking, chewing or putting pen caps in their mouths. A way of avoiding

the risk of inhalation of caps of writing and marking instruments is to manufacture products without

caps whenever possible. However, if caps are essential, the provisions of this document minimize risk

by specifying the design and performance of ventilated caps, which reduce the likelihood of inhalation

and delay asphyxiation pending medical intervention.

ISO/TC 10 recognizes that while it is possible to identify the age range of the children who are most

at risk, it is not possible to identify with certainty any writing instruments with detachable caps th

...

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