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Prefilled syringes -- Glass cylinders for dental local anaesthetic cartridges
This part of ISO 11040 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only.
NOTE 1: Cartridges of 1,0 ml size are described in ISO 11499.
It applies to primary packs used in direct contact with a drug.
NOTE 2: 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.
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