Sterile pen needles, intended for use with an adjustable pen for subcutaneous injections. Disposable, non-pyrogenic, non-toxic. Individually packaged, with a protective cap.
They do not contain latex.
General features
Needle with a sharp tip in three planes (triple bevel), processed through a fully automated robotic process.
Silicone-coated needle to facilitate skin penetration and reduce patient discomfort.
Anti-friction treatment applied to the cartridge end to facilitate piercing the cartridge septum from the adjustable pen injector.
Sterilized with ethylene oxide (10% concentration).
Complies with EN ISO 11608-2 standard.
The packaging is provided with a removable section (cutout).
Indications for use
Subcutaneous injection therapy.
Medical device according to Directive 93/42/EEC, as amended by Directive 2007/47/EC (transposed into Italian law by Legislative Decree no. 37 of 25 January 2010).
Class IIa
Conformity
EN ISO 11608-2: Needles for injection pens
EN ISO 7864: Sterile single-use hypodermic needles
EN ISO 9626: Stainless steel
ISO 2859: Sampling plans
EN ISO 11135: Sterilization
EN ISO 10993-1: Biocompatibility; Quality assurance system certified according to ISO 9001
Quality assurance system certified according to ISO 13485