Prefilled Syringes - Part 1: Glass Cylinders for Dental Local Anaesthetic Cartridges
|Publication Date:||1 December 2015|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
|ICS Code (Dental equipment):||11.060.20|
|ICS Code (Syringes, needles and catheters):||11.040.25|
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.