Injection equipment for medical use Ampoules for injectables

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2010

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
4 Material
5 Requirements
6 Test for breaking force
7 Delivery
8 Packaging
9 Marking
Bibliography

Defines materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.

This part of ISO9187 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 manufacturer and user.

Ampoules complying with this part of ISO9187 are intended for single use only.

Committee	CH/212
DevelopmentNote	Supersedes BS 795(1983) and 98/563716 DC. (08/1999)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current
Supersedes	BS 795:1983 BS EN ISO 9187-1:2008 98/563716 DC : OCT 98

Standards	Relationship
I.S. EN ISO 9187-1:2010	Identical
EN ISO 9187-1:2010	Identical
NEN EN ISO 9187-1 : 2010	Identical
ISO 9187-1:2010	Identical
NF EN ISO 9187-1 : 2010	Identical
DIN EN ISO 9187-1:2011-01	Identical
NS EN ISO 9187-1 : 2010	Identical
SN EN ISO 9187-1 : 2011	Identical
UNE-EN ISO 9187-1:2011	Identical
UNI EN ISO 9187-1 : 2010	Identical
NBN EN ISO 9187-1 : 2010	Identical

ISO 720:1985	Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification
ISO 1101:2017	Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out
ISO 4802-2:2016	Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
ISO 4802-1:2016	Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
ISO 7500-1:2015	Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system

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BS EN ISO 9187-1:2010

Injection equipment for medical use Ampoules for injectables

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory