ISO/FDIS 11040-3

FINAL DRAFT
International
Standard
ISO/TC 76
Prefilled syringes —
Secretariat: DIN
Part 3:
Voting begins on:
2025-08-19
Seals for dental local anaesthetic
cartridges
Voting terminates on:
2025-10-14
Seringues préremplies —
Partie 3: Rondelles d'étanchéité pour cartouches dentaires
d'anesthésie locale
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
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.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 76
Prefilled syringes —
Secretariat: DIN
Part 3:
Voting begins on:
Seals for dental local anaesthetic
cartridges
Voting terminates on:
Seringues préremplies —
Partie 3: Rondelles d'étanchéité pour cartouches dentaires
d'anesthésie locale
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.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 3
7 Material. 3
7.1 Cap .3
7.2 Liner .3
8 Requirements . 3
8.1 General .3
8.2 Physical requirements .4
8.2.1 Hardness .4
8.2.2 Fragmentation .4
8.2.3 Freedom from leakage .4
8.2.4 Resistance to ageing .4
8.3 Chemical requirements . .4
8.4 Biological requirements .4
9 Labelling . 4
Annex A (normative) Leakage test . 5
Bibliography .7

iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 11040-3:2012), which has been technically
revised.
The main changes are as follows:
— the terms and definitions clause (Clause 3) has been added and subsequent clauses have been renumbered;
— the normative references have been updated;
— Figure 1 and Table 1 have been updated;
— opening diameter and aluminium thickness dimensions have been added in Table 1;
— the term “user” was replaced by “manufacturer” and “customer” for clarity;
— “coated” was added in the material description in 7.1;
— disc was replaced by liner;
— ISO 13926-3 has been added to the bibliography.
A list of all parts of ISO 11040 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
The elastomeric parts specified in the ISO 11040 series are produced from rubber and thermoplastic
elastomers (TPE).
Primary packaging components are an integral part of medicinal products. Therefore, the principles of
current good manufacturing practices (cGMP) apply to the manufacturing of these components.
Principles of cGMP are described in ISO 15378 or in the GMP Guidelines published by the European
Community and the United States of America.

v
FINAL DRAFT International Standard ISO/FDIS 11040-3:2025(en)
Prefilled syringes —
Part 3:
Seals for dental local anaesthetic cartridges
1 Scope
This document specifies the shape, dimensions, material, performance requirements and labelling of seals
for dental local anaesthetic cartridges intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be
significantly affected by the nature and performance of the primary packaging.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 48-4, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation hardness by
durometer method (Shore hardness)
ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 7885:2010, Dentistry — Sterile injection needles for single use
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in
aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological
requirements and test methods
ISO 8871-5:2025, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional
requirements and testing
ISO 8872, Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General
requirements and test methods
ISO 11040-1, Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
ISO 11040-2, Prefilled syringes — Part 2: Plunger stoppers for dental local anaesthetic cartridges
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

3.1
customer
business entity which purchases primary packaging components and conducts further processing as
appropriate
3.2
liner
disc
mono-layer or double-layer of the elastomer component of a container, which seals the end of the container
through which the medicinal product is accessed
3.3
seal
combination of a mono-layer or double-layer liner (3.2) with an aluminium cap
3.4
manufacturer
business entity which performs or is responsible for the manufacturing of the primary packaging
components, including further processing, as appropriate
3.5
purified water
water obtained by a suitable process and contains no added substance
4 Classification
Seals shall be classified as follows:
— type A: seals with a mono-layer liner;
— type B: seals with a double-layer liner.
5 Shape and dimensions
5.1 The shape and dimensions of seals shall be as shown in Figure 1 and given in Table 1.
a) Type A: Seal with a mono-layer liner b) Type B: Seal
...