ISO 11540:2021

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

Pisala in označevalna sredstva - Specifikacija zaščitnih pokrovčkov za zmanjšanje tveganja zadušitve

Ta dokument določa zahteve za zmanjšanje tveganja zadušitve z zaščitnimi pokrovčki pisal in označevalnih sredstev. Navezuje se na taka pisala in sredstva, ki jih bodo v običajnih ali predvidljivih okoliščinah predvidoma uporabljali otroci do 14. leta starosti.
Ta dokument se ne uporablja za naslednje izdelke:
– pisala in označevalna sredstva, ki so oblikovana za odrasle ali so namenjena le odraslim, npr. prestižna pisala, draga nalivna peresa, strokovni tehnični svinčniki, odstranljivi pokrovčki za ponovno polnjenje.

General Information

• Status: Published
• Publication Date: 02-Aug-2021
• ICS: 97.180 - Miscellaneous domestic and commercial equipment
• ICS: 97.190 - Equipment for children
• Technical Committee: ISO/TC 10 - Technical product documentation
• Drafting Committee: ISO/TC 10/WG 18 - Drawing and writing instruments
• Current Stage: 6060 - International Standard published
• Start Date: 03-Aug-2021
• Due Date: 05-Apr-2022
• Completion Date: 03-Aug-2021
• Ref Project: SIST ISO 11540:2022 - Writing and marking instruments - Specification for caps to reduce the risk of asphyxiation

Relations

• Revises: ISO 11540:2014 - Writing and marking instruments - Specification for caps to reduce the risk of asphyxiation
• Effective Date: 17-Jul-2021

Overview

ISO 11540:2021 specifies safety requirements for caps on writing and marking instruments to reduce the risk of asphyxiation, particularly for products that children up to 14 years of age are likely to use. The standard applies to detachable caps and requires either a cap size that is too large to be inhaled or ventilation performance that allows sufficient airflow if a cap becomes lodged in the airway. It excludes instruments designed or intended only for adults (e.g., jewellery pens, expensive fountain pens, professional technical pens) and transit caps for refills.

Key topics and technical requirements

• Conformity options: Caps must meet at least one of two options:
  • Cap size test (4.2) - A cap introduced perpendicular to a 16 mm ring gauge (≥19 mm thickness) must have at least 5 mm of length that does not enter under its own weight; caps meeting this are deemed too large to inhale.
  • Ventilated caps air flow (4.3) - Caps tested per Annex A must permit a minimum air flow of 8 L/min at a maximum pressure drop of 1.33 kPa (measured at room temperature). Caps meeting this are deemed not to present an asphyxiation hazard.
• Airflow test method (Annex A):
  • Cap is fully inserted into elastomeric tubing; airflow and pressure drop measured in both directions.
  • Apparatus includes pulse-free air supply, flow regulator, flowmeter (5–10 L/min accuracy ±0.2 L/min), and pressure gauge (accuracy ±0.01 kPa).
  • Elastomeric tubing internal diameter: 80–85% of the cap’s circumscribing circle; wall thickness 0.75 mm ±0.25 mm; Shore A hardness 55 ±10.
• Design guidance (Annex B):
  • Continuous air passage of at least 6.8 mm along the cap body, extending to within 2 mm of both ends.
  • Cross-sectional vent area may be assessed by the cotton-thread method or CAD. Clips providing ventilation must be securely fixed and extend to within 2 mm of each end.
• Test reporting and identification (4.4 & 5):
  • Test reports must state whether the cap conforms via size or airflow and include tubing size, number of caps tested, bi-directional airflow results, and minimum flow recorded.
  • Products must be legibly identified with manufacturer/supplier name or trademark.

Applications and users

• Product designers and manufacturers of pens, markers and caps - to design caps that comply with child-safety requirements.
• Product safety engineers and compliance officers - for conformity assessment and documentation.
• Test laboratories - to perform the Annex A airflow test and produce compliant test reports.
• Regulators and procurement - for specifying safety requirements for school and children's stationery.

Related standards

• ISO 11540 references ISO 1938-1 (geometrical product specifications - plain limit gauges). Manufacturers should also consider relevant product safety and toy-safety regulations when placing items intended for children on the market.

Keywords: ISO 11540, pen cap safety, ventilated caps, asphyxiation risk, writing and marking instruments, cap airflow test, elastomeric tubing, cap design guidance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2022
Nadomešča:
SIST ISO 11540:2015
Pisala in označevalna sredstva - Specifikacija zaščitnih pokrovčkov za zmanjšanje
tveganja zadušitve
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
Ta slovenski standard je istoveten z: ISO 11540:2021
ICS:
97.180 Razna oprema za dom in Miscellaneous domestic and
trgovino commercial equipment
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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 2021
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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
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

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 i
...

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 2021
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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
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

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)
...