Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2026)
Abstract
This document is the German translation of the International Standard ISO 11040-8, which was developed by Technical Committee ISO/TC 76 “Transfusion, infusion, and injection, and blood processing equipment for medical and pharmaceutical use,” whose secretariat is held by DIN (Germany). The responsible national standards body is Working Committee NA 176-04-04 AA “Packaging Systems for the Filling and Administration of Medical Products” within the DIN Standards Committee for Health Technologies (NAGesuTech). This part of ISO 11040 is, based on ISO 11040-4 or ISO 11040-6 in conjunction with ISO 11040-5, applies to aseptically prefilled or prefilled syringes sterilized in their final packaging (intended for single use only) for parenteral injection preparations, with a focus on quality, functional performance, and safety, as well as the relevant test methods.
Begin
2026-08-11
Planned document number
DIN ISO 11040-8
Project number
17600253
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
