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‑use glass cylinders (cartridges) used to contain dental local anaesthetics. It covers glass cylinders with nominal volumes of 1.7 ml, 1.8 ml and 2.2 ml, and applies to primary packaging that is in direct contact with a drug. The standard links material and performance requirements to the safety, potency and stability of the contained drug.
Key topics and technical requirements
- Design & dimensions
- Typical lengths: 62.4 ± 0.4 mm (1.7/1.8 ml) and 75.0 ± 0.4 mm (2.2 ml).
- Neck opening: 3.15 ± 0.15 mm over a depth of 5 ± 0.2 mm; truncated‑cone geometry allowed within specified tolerances.
- Material
- Colourless glass of hydrolytic resistance grain class ISO 720 HGA 1.
- Manufacturers should notify users of glass composition changes at least nine months before implementation.
- Performance & integrity
- Internal surface hydrolytic resistance must meet ISO 4802 HC 1 (tested per ISO 4802‑1 or ISO 4802‑2). Before testing, the cylinder bottom shall be sealed (e.g., silicon rubber).
- Sealing surface at neck must be flat and free from ripples to ensure sealing performance.
- No seeds/bubbles or internal air lines that interfere with visual inspection or cause leakage.
- If annealed, residual stress must not produce optical retardation exceeding 40 nm/mm of glass thickness (test method by agreement).
- Marking & traceability
- Outer packaging must be marked with size, quantity, cylinder designation, manufacturer name/symbol and lot number or production date.
- Normative references
Applications and who uses this standard
- Manufacturers of dental local anaesthetic cartridges and glass tubing - to design, produce and qualify compliant glass cylinders.
- Quality control & testing laboratories - to perform hydrolytic resistance, visual inspection and residual stress checks.
- Medical device regulators and auditors - to verify primary packaging meets material and performance requirements for drug contact.
- Procurement and OEMs - for supplier specifications, acceptance criteria and traceability of single‑use cartridges.
- Dental product designers ensuring cartridge compatibility with syringes and seals.
Related standards
- ISO 11040 series (Parts 2–8) - covers stoppers, seals, barrels, plungers and packaging for prefilled syringes.
- ISO 11499 - single‑use dental cartridges of 1.0 ml size.
- ISO 720, ISO 4802‑1, ISO 4802‑2 - referenced test methods for hydrolytic resistance.
Keywords: ISO 11040-1:2015, prefilled syringes, glass cylinders, dental local anaesthetic cartridges, hydrolytic resistance, cartridge dimensions, single‑use dental cartridges.
Open preview (PDF)Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges