The ISO 11499 standard, developed by the International Standards Organization (ISO), describes the characteristics and test methods of disposable cartridges used by dentists in local anesthesia. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 11499 Dentistry - Disposable cartridges for locally applied anesthetics.
This standard describes specific performance requirements for disposable dental cartridges with 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anesthetics. This standard provides methods for leakage, plunger action, removable volume, and underfill testing and lists overall dimensions to ensure the cartridge fits dental cartridge syringes. It also describes the labeling requirements for these cartridges.
The safe and efficient operation of dental cartridges (dental cartridges) for local anesthetics depends on their leakage freeness, control of the forces required to initiate and maintain piston movement, and the absence of large air bubbles. In order to avoid unacceptable biological hazards, specific qualitative and quantitative test methods are provided in the ISO 11499 standard. However, it is recommended to refer to ISO 10993-1 and ISO 7405 standards for the assessment of potential biological hazards.
On the other hand, this standard lists the overall dimensions of the cartridge in terms of compliance with dental cartridge syringes that comply with ISO 9997 and ISO 21533 standards, as well as offering leakage, piston movement, removable volume and underfilling test methods.
The standards that are referred to as normative in the implementation of the ISO 11499 standard and indispensable for its implementation are: ISO 1942, ISO 7885, ISO 9997, ISO 15223-1 and ISO 21533.
Our organization also provides testing services for the disposable cartridges used by ISO 11499 dentists in local anesthesia, within the scope of laboratory services.
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