QUALITY CONTROL

« Because technology concerns, above all, the patients’ safety »

For more than 15 years, MEMOMETAL designs, manufactures and markets implants for orthopaedic surgery : we control all production procedures.
Through this experience, we guarantee the clients’ safety together with the tracability and reliability of our components. Each production line is planned, carried out and recorded by qualified operators. You will find hereunder the different procedures that are respected for our implants and ancillaries. And of course, we are available for any information request you may have.

Chemical monitoring of the batches

Each batch of material used for manufacturing implants undergoes a chemical analysis corresponding to the ISO 10993 standards.
Each batch of material used for manufacturing instruments undergoes a chemical analysis corresponding to the NFS 94-090 standards.

Microbiological monitoring of the batches

For each product family in the MEMOMETAL range, method validation for estimating the micro-organism population is carried out (Bioburden, partaining to the ISO 11737-1 standards)

Sterilisation of the implants

The minimum dose of sterilisation of 25kGy was validated according to the ISO 11137 standards (VDMax method) based on microbiological results obtained before applying the verification dose. These audits are carried out for each product family of the MEMOMETAL range.

The cytotoxicity is tested at each significant change of manufacturing process according to standards NF/EN/ISO10993-5 ; The presence of endotoxinesis is routinely controlled according to the 4th European pharmacopeia edition 2.6.14 (quantitative method by cinetic colorimetry)

Operational qualification of sterilisation

Dose cartography is carried out at each recharging of the irradiation source.

Non sterile implants and ancillaries

The cleaning and decontamination range was validated on the whole MEMOMETAL range according to AAMI TIR 12 (5 layers and a high level of contamination). The ATNC cycle of sterilisation in autoclave 134°C/18 min was validated according to AAMI TIR 12 (5 layers and a high level of contamination). The composition of each ancillary is traced and the monitoring of this tracability is carried out according to the circular DH/DGS n° 138 of March 14 2001.