Certification: ISO 10993

For medical and packaging equipment for the pharmaceutical industry we produce reliable, safe and biocompatible products. The non-toxic properties of PTFE – even at high operating temperatures – combined with its selflubrication capacity and chemical inertia, make it suitable for this specific sector.

ISO-10993 is a standard, that use systemic toxicity and intracutaneous reactivity testing. It also includes additional cytotoxicity, genotoxicity, chronic toxicity, and hemocompatibility tests, as well as more involved systemic toxicity testing. It categorizes medical devices according to nature and duration of body contact The additional intensity of ISO-10993 testing is due to it primarily being required for medical devices that will be permanently or semi-permanently implanted into a patient.

For devices that are not intended to be implanted or will have limited contact with patients, ISO10993 testing may be more extensive than necessary.