ISO 11499:2014 PDF

Scope: This International Standard gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics. It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with Labelling requirements are also specified. NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.

ISO 11499:2014 Referenced Document

ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11040-1:1992 Prefilled syringes; part 1: glass cylinders for dental local anaesthetic cartridges
ISO 11040-2:2011 Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges
ISO 11040-3:2012 Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 1942:2009 Dentistry - Vocabulary
ISO 21533:2003 Dentistry - Reusable cartridge syringes intended for intraligamentary injections
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7500-1:2004 Metallic materials - Verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Verification and calibration of the force-measuring system
ISO 7885:2010 Dentistry - Sterile injection needles for single use
ISO 9997:1999 Dental cartridge syringes