ISO 11040-1:2015
(Main)Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges
Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges
ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
Seringues préremplies — Partie 1: Tubes en verre pour cartouches dentaires d'anesthésie locale
General Information
- Status
- Published
- Publication Date
- 18-Nov-2015
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 26-Apr-2021
- Completion Date
- 13-Dec-2025
Relations
- Effective Date
- 26-Jul-2014
Overview
ISO 11040-1:2015 - Prefilled syringes, Part 1: Glass cylinders for dental local anaesthetic cartridges - specifies the design, dimensions, materials, performance and test methods for single‑use glass cylinders (cartridges) used to contain dental local anaesthetics. It covers glass cylinders with nominal volumes of 1.7 ml, 1.8 ml and 2.2 ml, and applies to primary packaging that is in direct contact with a drug. The standard links material and performance requirements to the safety, potency and stability of the contained drug.
Key topics and technical requirements
- Design & dimensions
- Typical lengths: 62.4 ± 0.4 mm (1.7/1.8 ml) and 75.0 ± 0.4 mm (2.2 ml).
- Neck opening: 3.15 ± 0.15 mm over a depth of 5 ± 0.2 mm; truncated‑cone geometry allowed within specified tolerances.
- Material
- Colourless glass of hydrolytic resistance grain class ISO 720 HGA 1.
- Manufacturers should notify users of glass composition changes at least nine months before implementation.
- Performance & integrity
- Internal surface hydrolytic resistance must meet ISO 4802 HC 1 (tested per ISO 4802‑1 or ISO 4802‑2). Before testing, the cylinder bottom shall be sealed (e.g., silicon rubber).
- Sealing surface at neck must be flat and free from ripples to ensure sealing performance.
- No seeds/bubbles or internal air lines that interfere with visual inspection or cause leakage.
- If annealed, residual stress must not produce optical retardation exceeding 40 nm/mm of glass thickness (test method by agreement).
- Marking & traceability
- Outer packaging must be marked with size, quantity, cylinder designation, manufacturer name/symbol and lot number or production date.
- Normative references
- References include ISO 720, ISO 4802‑1, ISO 4802‑2 (hydrolytic resistance tests).
Applications and who uses this standard
- Manufacturers of dental local anaesthetic cartridges and glass tubing - to design, produce and qualify compliant glass cylinders.
- Quality control & testing laboratories - to perform hydrolytic resistance, visual inspection and residual stress checks.
- Medical device regulators and auditors - to verify primary packaging meets material and performance requirements for drug contact.
- Procurement and OEMs - for supplier specifications, acceptance criteria and traceability of single‑use cartridges.
- Dental product designers ensuring cartridge compatibility with syringes and seals.
Related standards
- ISO 11040 series (Parts 2–8) - covers stoppers, seals, barrels, plungers and packaging for prefilled syringes.
- ISO 11499 - single‑use dental cartridges of 1.0 ml size.
- ISO 720, ISO 4802‑1, ISO 4802‑2 - referenced test methods for hydrolytic resistance.
Keywords: ISO 11040-1:2015, prefilled syringes, glass cylinders, dental local anaesthetic cartridges, hydrolytic resistance, cartridge dimensions, single‑use dental cartridges.
Frequently Asked Questions
ISO 11040-1:2015 is a standard published by the International Organization for Standardization (ISO). Its full title is "Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges". This standard covers: ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
ISO 11040-1:2015 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.040.25 - Syringes, needles an catheters; 11.060.20 - Dental equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 11040-1:2015 has the following relationships with other standards: It is inter standard links to ISO 11040-1:1992. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 11040-1:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11040-1
Second edition
2015-12-01
Prefilled syringes —
Part 1:
Glass cylinders for dental local
anaesthetic cartridges
Seringues préremplies —
Partie 1: Tubes en verre pour cartouches dentaires d’anesthésie locale
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2015 – All rights reserved
Contents Page
Foreword .iv
1 Scope .1
2 Normative references .1
3 Dimensions and designation .1
3.1 Dimensions . 1
3.2 Designation . 2
4 Requirements . 2
4.1 Material . 2
4.2 Performance . 2
5 Marking . 2
Bibliography .4
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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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
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For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 11040-1:1992), which has been technically
revised with the following changes:
— including glass cylinders of 2,2 ml size;
— amending the requirements on performance and marking;
— editorial revision of this part of ISO 11040-1.
ISO 11040 consists of the following part
...
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