ISO 11418-5:2015
Current
The latest, up-to-date edition.
Containers and accessories for pharmaceutical preparations Part 5: Dropper assemblies
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
02-27-2015
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ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations.
This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1.
Dropper assemblies are applicable to primary packs used in direct contact with the drug.
NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
| DevelopmentNote |
Supersedes ISO/DIS 11418-5. (03/2015)
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IS/ISO 11418 : Part 5 : 2015 | Identical |
| DIN ISO 11418-5:2016-08 (Draft) | Identical |
| BS ISO 11418-5:2015 | Identical |
| DIN ISO 11418-5 E : 2017 | Identical |
| NEN ISO 11418-5 : 2015 | Identical |
| DIN ISO 11418-5:2017-02 | Identical |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| ISO 720:1985 | Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification |
| ISO 11418-1:2016 | Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing glass bottles |
| ISO 719:1985 | Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classification |
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