ISO 11040-3:2025

Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges

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.

Seringues préremplies — Partie 3: Rondelles d'étanchéité pour cartouches dentaires d'anesthésie locale

La présente partie de l'ISO 11040 spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des rondelles d'étanchéité pour cartouches dentaires d'anesthésie locale à usage unique seulement. NOTE La nature et les performances de l'emballage primaire peuvent influer considérablement sur l'efficacité, la pureté, la stabilité et la sécurité d'un produit pharmaceutique au cours de sa fabrication et de son stockage.

General Information

• Status: Published
• Publication Date: 06-Nov-2025
• ICS: 11.040.25 - Syringes, needles an catheters
• ICS: 11.060.20 - Dental equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Current Stage: 6060 - International Standard published
• Start Date: 07-Nov-2025
• Due Date: 27-Apr-2026
• Completion Date: 07-Nov-2025

Relations

• Revises: ISO 11040-3:2012 - Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges
• Effective Date: 06-May-2023

Overview

ISO 11040-3:2025 - Prefilled syringes: Seals for dental local anaesthetic cartridges specifies the shape, dimensions, materials, performance requirements and labelling of single‑use seals (aluminium cap + elastomeric liner) used on dental local anaesthetic cartridges. The standard emphasizes the role of primary packaging in maintaining the potency, purity, stability and safety of medicinal products and aligns component production with good manufacturing practice (cGMP) principles.

Key topics and technical requirements

• Classification
  • Type A: mono‑layer liner
  • Type B: double‑layer liner (both layers continuous; layer thickness ratio agreed with customer)
• Shape & dimensions
  • Standard nominal size example: 7.5 mm opening diameter.
  • Typical cap/liner ranges (as specified): Type A cap height ~4.85–4.90 mm, liner thickness 1.3–1.5 mm; Type B cap height up to 5.3 mm, liner thickness 1.45–1.95 mm. Aluminium thickness to be agreed (example range 0.15–0.25 mm).
• Materials
  • Aluminium cap: anodized, lacquered or suitably coated (see ISO 8872).
  • Liner: elastomer or TPE formulation approved by the customer; manufacturer must ensure batch conformity.
  • Liner must withstand two autoclave cycles at (121 ± 2) °C for 30 min (or be validated for other sterilization methods).
• Physical performance
  • Hardness: ±5 IRHD from the agreed nominal value (tested per ISO 48‑4).
  • Fragmentation: test per ISO 8871‑5:2025 using a 0.4 mm outer diameter needle (butt‑end needle geometry per ISO 7885).
  • Freedom from leakage: assessed using the Annex A leakage test (water‑filled cartridges, 30 ± 1 N applied for 1 minute on a set of 10 cartridges).
  • Ageing: seals must maintain performance over agreed shelf‑life; storage guidance per ISO 2230.
• Chemical & biological
  • Chemical extractables per ISO 8871‑1; biological requirements and test methods per ISO 8871‑4. Biological hazard assessment may follow ISO 10993‑1 when relevant.
• Labelling & designation
  • Designation format e.g. Seal ISO 11040-3 - A for type A seals.

Applications and users

This standard is intended for:

• Manufacturers of elastomeric seals, aluminium caps and prefilled dental cartridges
• Pharmaceutical pack producers and contract packagers producing dental local anaesthetic cartridges
• Quality, regulatory and validation engineers who perform incoming inspection, stability and compatibility testing
• Procurement and R&D teams specifying primary packaging for dental injectable products Use cases include component design, supplier qualification, incoming acceptance testing, and regulatory documentation to demonstrate compliance for dental cartridge primary packaging.

Related standards

• ISO 11040 series (Parts 1 & 2) - glass cylinders and plunger stoppers for dental cartridges
• ISO 8871‑1, ISO 8871‑4, ISO 8871‑5:2025 - elastomeric parts requirements and tests
• ISO 48‑4 (hardness), ISO 3302‑1 (dimensional tolerances), ISO 7885 (injection needles)
• ISO 8872 (aluminium caps), ISO 15378 (cGMP for primary packaging)

Keywords: ISO 11040-3, prefilled syringes, seals for dental local anaesthetic cartridges, dental cartridges, liner, aluminium cap, leakage test, elastomeric parts, sterilization, cGMP.

Standards Content (Sample)

International
Standard
ISO 11040-3
Third edition
Prefilled syringes —
2025-11
Part 3:
Seals for dental local anaesthetic
cartridges
Seringues préremplies —
Partie 3: Rondelles d'étanchéité pour cartouches dentaires
d'anesthésie locale
Reference number
© ISO 2025
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
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
International Standard ISO 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 sa
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