EN ISO 9187-1:2010

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user.
Ampoules complying with ISO 9187-1:2010 are intended for single use only.

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010)

Dieser Teil von ISO 9187 legt Werkstoffe, Maße, das Volumen, die Leistung und Anforderungen an die Verpackung für drei Formen von Ampullen aus Glas (Formen B, C und D) für Injektionspräparate fest.
Er gilt für Ampullen ohne und mit Farbbrechring; die Bereitstellung von Ampullen mit Farbbrechring und die Wahl der Farbe des Farbbrechrings ist zwischen Hersteller und Anwender zu vereinbaren.
Ampullen nach diesem Teil von ISO 9187 sind nur zur einmaligen Verwendung bestimmt.

Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)

L'ISO 9187-1:2010 spécifie les matériaux, les dimensions, les capacités, ainsi que les exigences relatives à la performance et à l'emballage de trois types d'ampoules en verre (types B, C et D) pour les produits pharmaceutiques injectables.
L'ISO 9187-1:2010 s'applique aux ampoules avec ou sans anneau de cassure coloré; la livraison d'ampoules avec anneau de cassure coloré ainsi que la spécification de la couleur désirée de l'anneau de cassure font l'objet d'un accord entre le fabricant et l'utilisateur.
Les ampoules conformes à l'ISO 9187-1:2010 sont destinées à un usage unique.

Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:2010)

Ta del ISO 9187 določa zahteve za materiale, dimenzije, prostornine, zmogljivost in embalažo za tri oblike steklenih ampul (oblike B, C in D) za farmacevtske izdelke za injiciranje. Velja za ampule z ali brez barvnega obročka; nabava ampul z barvnimi obročki in izbira barv obročka je predmet dogovora med proizvajalcem in uporabnikom. Ampule, ki jih določa ta del ISO 9187, so namenjena le enkratni uporabi.

General Information

• Status: Published
• Publication Date: 14-Oct-2010
• Withdrawal Date: 29-Apr-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Oct-2010
• Completion Date: 15-Oct-2010
• Ref Project: SIST EN ISO 9187-1:2011 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

Relations

• Replaces: EN ISO 9187-1:2008 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006)
• Effective Date: 23-Jan-2010

Overview

EN ISO 9187-1:2010 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010) is a CEN-endorsed international standard that specifies the materials, dimensions, capacities, performance and packaging requirements for glass ampoules used as primary containers for injectable pharmaceutical products. The standard covers three ampoule forms in current pharmaceutical use (forms B, C and D) and applies to ampoules with or without a colour break‑ring. Ampoules complying with this standard are intended for single use only.

Key topics and technical requirements

• Ampoule forms & sizes: Defines geometrical dimensions and nominal volumes for forms B, C and D (common nominal volumes include 1, 2, 3, 5, 10, 20, 25 and 30 ml).
• Glass material: Specifies the use of colourless (cl) or amber (br) glass of hydrolytic resistance grain class HGA 1 (ISO 720). Manufacturers must notify users of chemical composition changes in advance.
• Hydrolytic resistance: Internal surface resistance classified to container classes HCT 1 and HCF 1 when tested per ISO 4802‑1 and ISO 4802‑2.
• Annealing and stress: Ampoules must be annealed; uncoloured ampoules have limits on residual optical retardation to control stress.
• Breaking performance: Specifies a tensile breaking test (separation of stem from body) using a tensile testing machine per ISO 7500‑1 (test speed typically 10 mm/min, appropriate force range). All individual test results must meet the values in the standard’s breaking‑force table.
• Sampling & testing: Recommends sampling schemes per ISO 2859‑1 (e.g., inspection level S‑4) and stipulates conditioning and test reporting requirements.
• Packaging & marking: Defines a typical packaging unit internal footprint (384 × 143 mm) and requires marking of manufacturer name/address and full designation (form, nominal volume, glass colour, break‑ring where applicable).

Applications

• Ensures consistent primary packaging for parenteral pharmaceuticals to reduce risk of drug-container interactions and maintain patient safety.
• Used to design, manufacture and qualify production ampoules, internal QC tests, incoming inspection and supplier agreements.
• Supports regulatory submissions and quality-system controls for pharmaceutical containers and parenteral product fills.

Who uses this standard

• Pharmaceutical companies (packaging and regulatory teams)
• Glass ampoule manufacturers and converters
• Medical device and packaging engineers
• Quality control / analytical laboratories and validation teams
• Hospital procurement and sterile‑supply specialists

Related standards

• ISO 9187‑2 (One‑point‑cut (OPC) ampoules)
• ISO 720, ISO 4802‑1 / ISO 4802‑2 (hydrolytic resistance)
• ISO 7500‑1 (tensile testing machine verification)
• ISO 2859‑1 (sampling by attributes)
• ISO 1101 (geometrical tolerancing)

This standard is essential for anyone specifying, producing or qualifying glass ampoules for injectables, helping ensure dimensional consistency, material suitability and safe single‑use performance.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:2010)Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010)Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 9187-1:2010SIST EN ISO 9187-1:2011en01-januar-2011SIST EN ISO 9187-1:2011SLOVENSKI
STANDARDSIST EN ISO 9187-1:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 9187-1
October 2010 ICS 11.040.20 Supersedes EN ISO 9187-1:2008English Version
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)
Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010) This European Standard was approved by CEN on 13 October 2010.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-1:2010: ESIST EN ISO 9187-1:2011

Reference numberISO 9187-1:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO9187-1Fourth edition2010-10-15Injection equipment for medical use — Part 1: Ampoules for injectables Matériel d'injection à usage médical — Partie 1: Ampoules pour produits injectables
ISO 9187-1:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2010 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.
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ISO 9187-1:2010(E) © ISO 2010 – All rights reserved 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. 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 9187-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This fourth edition cancels and replaces the third edition (ISO 9187-1:2006), which has undergone a minor revision with the following modifications in Table 1. ⎯ The base radius, r, has been modified for the 10 ml, 20 ml, 25 ml and 30 ml glass. ISO 9187 consists of the following parts, under the general title Injection equipment for medical use: ⎯ Part 1: Ampoules for injectables ⎯ Part 2: One-point-cut (OPC) ampoules SIST EN ISO 9187-1:2011

ISO 9187-1:2010(E) iv © ISO 2010 – All rights reserved Introduction Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary container over extended storage periods, possible interactions are to be avoided in order to guarantee patient safety. Adequate means to achieve this objective include proper selection of primary packaging materials, the choice of suitable package design and the availability of specific requirements and methods for testing individual container systems. In the past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread use. However, form A is no longer used in the pharmaceutical industry and consequently has not been included in this part of ISO 9187. To avoid any confusion among manufacturers and users, it was decided to retain the same designation letters (i.e. B, C and D) for the forms of ampoules in current use and to disregard the letter A.
INTERNATIONAL STANDARD ISO 9187-1:2010(E) © ISO 2010 – All rights reserved 1 Injection equipment for medical use — Part 1: Ampoules for injectables 1 Scope This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufac
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