ISO 11040-2:2011

Prefilled syringes — Part 2: Plunger stoppers for dental local anaesthetic cartridges

ISO 11040-2:2011 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local anaesthetic cartridges intended for single use only.

Seringues préremplies — Partie 2: Bouchons-pistons pour cartouches dentaires d'anesthésie locale

General Information

• Status: Published
• Publication Date: 17-Mar-2011
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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/WG 4 - Elastomeric parts and components and related secondary packaging components
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 06-Dec-2021

Relations

• Revises: ISO 11040-2:1994 - Prefilled syringes — Part 2: Plungers and discs for dental local anaesthetic cartridges
• Effective Date: 06-Mar-2009

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11040-2
Second edition
2011-04-01

Prefilled syringes —
Part 2:
Plunger stoppers for dental local
anaesthetic cartridges
Seringues préremplies —
Partie 2: Bouchons-pistons pour cartouches dentaires d'anesthésie
locale




Reference number
ISO 11040-2:2011(E)
©
ISO 2011

---------------------- Page: 1 ----------------------
ISO 11040-2:2011(E)


COPYRIGHT PROTECTED DOCUMENT


©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 11040-2:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11040-2 was prepared by Technical Committee 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 11040-2:1994), which has been technically
revised by:
⎯ aligning this International Standard with the ISO 8871 series;
⎯ separating requirements on plunger stoppers (this part of ISO 11040) and seals; the latter are now
completely covered by ISO 11040-3;
⎯ revising Table 1 on dimensions of plunger stoppers;
⎯ revising the requirements on material, hardness, freedom from leakage and sliding characteristics;
⎯ adding requirements on resistance to ageing.
ISO 11040 consists of the following parts, under the general title Prefilled syringes:
⎯ Part 1: Glass cylinders for dental local anaesthetic cartridges
⎯ Part 2: Plunger stoppers for dental local anaesthetic cartridges
⎯ Part 3: Seals for dental local anaesthetic cartridges
⎯ Part 4: Glass barrels for injectables
⎯ Part 5: Plunger stoppers for injectables
⎯ Part 6: Plastic barrels for injectables
© ISO 2011 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 11040-2:2011(E)
Introduction
Primary packaging components made of elastomeric materials are an integral part of medicinal products. As
such, the principles of current Good Manufacturing Practices (cGMP) are applicable to the manufacturing of
these components.
Principles of cGMP are described in ISO 15378, and in GMP Guidelines published by the European
[5] [6]
Community and the United States of America .

iv © ISO 2011 – All rights reserved

---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 11040-2:2011(E)

Prefilled syringes —
Part 2:
Plunger stoppers for dental local anaesthetic cartridges
1 Scope
This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of
plunger stoppers 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
affected significantly by the nature and performance of the primary packaging.
2 Normative references
The following referenced documents are indispensable for the application 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, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and
100 IRHD) [alternative normative reference to ISO 7619-1]
ISO 3302 (all parts), Rubber — Tolerances for products
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1:
Durometer method (Shore hardness) [alternative normative reference to ISO 48]
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 11040-1, Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
ISO 11040-3, Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
3 Classification
Plunger stoppers shall be classified as follows:
⎯ Type A: plunger stoppers without cavities;
⎯ Type B: plunger stoppers with one cavity;
⎯ Type C: plunger stoppers with two cavities.
© ISO 2011 – All rights reserved 1

---------------------- Page: 5 ----------------------
ISO 11040-2:2011(E)
4 Shape and dimensions
4.1 Shape and dimensions of plunger stoppers shall be as shown in Figure 1 and as given in Table 1.

a)  Type A b)  Type B c)  Type C
Key
d , d diameters of plunger stoppers
1 2
Figure 1 — Shape and dimensions of plunger stoppers showing positions of cavities
Table 1 — Dimensions of plunger stoppers
Dimensions in millimetres

Diameter
N
...