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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…
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 11040-2:2011 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 11040-8:2016 - 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 11040-7:2024 - 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 11040-3:2025 - Prefilled syringes: Seals for dental local anaesthetic cartridges specifies the shape, dimensions, materials, performance requirements and labelling of single‑use seals (a…
Overview ISO 11040-5:2012 defines requirements for plunger stoppers for injectables used in prefilled syringes (glass barrels, single‑chamber design). The standard specifies shape, dimensions, materi…
Overview ISO 11040-6:2019 specifies requirements for prefilled syringes made with polymer (plastic) barrels and for sterilized subassembled syringes ready for filling. The standard covers materials,…
Overview ISO 11040-4:2024 - Prefilled syringes, Part 4 specifies requirements for glass barrels for injectables and sterilized subassembled syringes ready for filling. It covers materials, dimensiona…
Overview ISO 11040-8:2026 sets comprehensive requirements and test methods for finished prefilled syringes intended for single-use parenteral preparations. Focused on both aseptically processed and t…
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…
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 packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests . Downstream processes (processes after fill…