Overview
EN ISO 11499:2014 - Dentistry: Single‑use cartridges for local anaesthetics specifies performance, dimensional and labelling requirements for single‑use dental cartridges (nominal capacities 1.0 ml, 1.7 ml, 1.8 ml and 2.2 ml). Endorsed by CEN and published as the third edition of ISO 11499, the standard sets test methods and acceptance criteria to ensure cartridges are compatible with dental cartridge syringes and safe for clinical use.
Key topics and requirements
- Scope and capacities: Applies to single‑use cartridges for local anaesthetics in the four nominal volumes listed above.
- Leakage: Filled cartridges shall be free from leakage; specific test procedure is given (see clause 5.4).
- Plunger movement (force):
- Force to initiate plunger movement shall not exceed 30 N.
- Force to sustain plunger movement along the effective length shall be between 2 N and 20 N (clause 4.2, test 5.5).
- Extractable volume & underfilling: Measured extractable volume must not be less than the declared nominal volume (test 5.7).
- Air bubble limit: Any air bubble must not be visible below the rim of the metal cap (test 5.6).
- External dimensions:
- Max overall length: 44.0 mm (1.0 ml), 65.0 mm (1.7/1.8 ml), 77.5 mm (2.2 ml).
- Max overall diameter (including label): 9.0 mm.
- Colour coding & labelling:
- Optional two‑band colour system to identify anaesthetic agent/concentration (Band 1) and vasoconstrictor/concentration (Band 2), with specified positions and Pantone references.
- Primary and secondary container marking requirements are specified.
- Biocompatibility: Components contacting the solution shall not adversely react with or contaminate the anaesthetic; the standard references ISO 10993‑1 and ISO 7405 for biological assessment guidance.
- Test methods: Sampling, environmental test conditions and specific test procedures are defined in clause 5.
Practical applications and users
- Cartridge manufacturers: design, production control, QC testing, and marking to meet regulatory and market requirements.
- Medical device testing labs: perform leakage, plunger force, extractable volume and dimensional tests.
- Regulatory and conformity assessment bodies: evaluate compliance for CE marking and national approvals.
- Syringe manufacturers and dental clinics: ensure compatibility with cartridge syringes (ISO 9997 / ISO 21533) and safe clinical handling.
- Procurement and quality teams: define specifications and acceptance criteria in purchasing and incoming inspection.
Related standards
For full test protocols and official legal text, obtain EN ISO 11499:2014 from CEN or your national standards body.
