DIN Standards Committee Health Technologies
DIN ISO 11040-1
Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges (ISO 11040-1:2015)
Vorgefüllte Spritzen - Teil 1: Glaszylinder für Dentalkarpulen zur Lokalanästhesie (ISO 11040-1:2015)
Overview
The International Standard ISO 11040-1:2015 has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" with the participation of German experts. The responsible national standardization committee is Working Committee NA 063-02-03 AA "Verpackungssysteme für die Befüllung und Applikation von medizinischen Produkten" ("Packaging systems for filling and application of medical products") at DIN Standards Committee Medicine (NAMed). 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. It applies to primary packs used in direct contact with a drug.
Document: references other documents
Responsible national committee
NA 176-04-04 AA - Packaging systems for loading and application of medical devices
Responsible international committee
ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
