Tecnofar Needles: Quality first
The quality of Tecnofar disposable needles
In the medical device sector, quality is essential to guarantee safe and efficient performance for both doctors and their patients. For this reason, products by the Tecnofar Needles division are individually inspected and comply will all the standards of reference for disposable anaesthesia needles for use in the dental sector.
Standards of reference
DIRECTIVE 93/42/EEC concerning medical devices and its subsequent amendments and additions
ISO 7885 – Dentistry – Sterile injection needles for single use
ISO 9626 – Stainless steel needle tubing for the manufacture of medical devices
ISO 10993/1 – Biological evaluation of medical devices
EN ISO 11137/1/2/3 – Sterilization of health care products – Radiation
EN ISO 11135 – Sterilization of health care products – Ethtylene oxide
ISO 14971 – Application of risk management to medical devices
CEI EN 1041 – Information supplied by the manufacturer of medical devices
EN 556/1 – Requirements for medical devices to be designated “STERILE”
EN ISO 15223/1 – Symbols to be used with medical device labels, labelling and information to be supplied
EN ISO 11607/1/2 – Packaging for terminally sterilized medical devices
We don't stop at co-designing, producing and guaranteeing high quality standards in the dental sector. Our guarantee continues after purchase as well, through our high-quality support service, dedicated to meeting any need that might arise, including after purchase.