QUALITY CONTROL & CERTIFICATIONS
Production and quality, in addition to CE requirements
DECONTAMINATION AND STERILISATION
The decontamination and washing processes are carried out in controlled and sterile settings. Packaging takes place in an ISO 100.000 clean room and is followed by a treatment with BETA rays. The external part of the package consists of a container bearing all the product data and a red toning stamp that guarantees the irradiation to which the product was subjected. Inside, the blister, which is guaranteed against ageing and for the sealing grip, as required by the regulations in force, repeats the same information and stamp, and is marked with a barcode. The sterile glass phials, which are the housing for the implant and its titanium maunt, and the blister that contains them constitute a double protection against contaminating agents. In the package, there are two labels that the doctor will be able to append to the patient’s clinical record and to the NSI Implant Passport.
The precise, thorough procedures implemented at our establishment guarantee the total integrity of our products. Every process takes place in a controlled, aseptic environment, from decontamination and washing to packaging carried out in an ISO 5 cleanroom.
- Prove meccaniche IMPIANTI NSI eseguite C/o laboratori ICIM CE 0571
- Prove meccaniche IMPIANTI MONOFASICI NSI eseguite C/o laboratori POLITECNICO DI MILANO 2019 secondo normative FDA
- Prove meccaniche IMPIANTI BIFASICI NSI eseguite C/o laboratori POLITECNICO DI MILANO 2019 secondo normative FDA
- Certificato ICIM N. 0425-MED-003136-00 – Approvazione del sistema Completo di Garanzia di Qualità
- Certificato ICIM N. 0425-MED-003137-00 – Approvazione del sistema Completo di Garanzia di Qualità
- Certificato del Sistema di Gestione per la Qualità ISO 13485:2012
- Istruzioni d’uso 2019