I.S. EN ISO 9187-1:2010
Current
The latest, up-to-date edition.
INJECTION EQUIPMENT FOR MEDICAL USE - PART 1: AMPOULES FOR INJECTABLES
Hardcopy , PDF
English
01-01-2010
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| 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 |
| BS EN ISO 9187-1:2010 | Identical |
| NBN EN ISO 9187-1 : 2010 | Identical |
| UNE-EN ISO 9187-1:2011 | 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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