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BS EN ISO 9187-1:2010

BS EN ISO 9187-1:2010

Current

Current

The latest, up-to-date edition.

Injection equipment for medical use Ampoules for injectables

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2010

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

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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Hardcopy - English
PDF - English
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