BS EN ISO 9187-1:2010
Current
The latest, up-to-date edition.
Injection equipment for medical use Ampoules for injectables
Hardcopy , PDF
English
30-11-2010
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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.
| 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 |
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.
| 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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