BS ISO 11040-1:2015

This standard BS ISO 11040-1:2015 Prefilled syringes is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment
• 11.060.20 Dental equipment
• 11.040.25 Syringes, needles and catheters

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.