ISO 11040-1:2015 PDF

Scope: This part of ISO 11040 speci fies 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.

ISO 11040-1:2015 Referenced Document

ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics
ISO 4802-1:2010 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
ISO 4802-2:2010 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
ISO 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification

2015 ISO 11040-1:2015 Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges
1992 ISO 11040-1:1992 Prefilled syringes; part 1: glass cylinders for dental local anaesthetic cartridges