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1 Scope This part of ISO 11040 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests . Downstream processes (processes after fill…
1 Scope This part of ISO 11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together wi…
1 Scope This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE Th…
Overview ISO 11040-8:2026 sets comprehensive requirements and test methods for finished prefilled syringes intended for single-use parenteral preparations. Focused on both aseptically processed and t…
Overview ISO 11040-4:2024 - Prefilled syringes, Part 4 specifies requirements for glass barrels for injectables and sterilized subassembled syringes ready for filling. It covers materials, dimensiona…
Overview ISO 11040-6:2019 specifies requirements for prefilled syringes made with polymer (plastic) barrels and for sterilized subassembled syringes ready for filling. The standard covers materials,…
Overview ISO 11040-5:2012 defines requirements for plunger stoppers for injectables used in prefilled syringes (glass barrels, single‑chamber design). The standard specifies shape, dimensions, materi…
Overview ISO 11040-3:2025 - Prefilled syringes: Seals for dental local anaesthetic cartridges specifies the shape, dimensions, materials, performance requirements and labelling of single‑use seals (a…
Overview ISO 11040-7:2024 - Prefilled syringes Part 7 - specifies packaging systems for sterilized subassembled syringes ready for filling. It defines the combination of tubs, nests, sealing lids, in…
Overview ISO 11040-8:2016 - Prefilled syringes, Part 8 - specifies requirements and test methods for finished prefilled syringes intended for single use. It applies to aseptically filled or terminall…
Overview ISO 11040-2:2011 is an international standard developed by the International Organization for Standardization (ISO) that specifies requirements for plunger stoppers used in dental local anae…
Overview ISO 11040-1:2015 - Prefilled syringes, Part 1: Glass cylinders for dental local anaesthetic cartridges - specifies the design, dimensions, materials, performance and test methods for single‑…
Overview ISO 11040-3:2012 specifies requirements for seals (elastomeric discs and aluminium caps) used in dental local anaesthetic cartridges for single use. The standard defines acceptable shape, di…