ISO 13485 standard

Graphenano Dental is in the process of implementing ISO 13485, referred to the Health Products Quality Management System, by the company Intedya (International Dynamic Advisors).

Cytotoxicity test

Biological assessment of the medical devices. In vitro cytotoxicity test with the product ACRYLIC DISC. (ISO Standard 10993-5:2009).

Test for genotoxicity

Reversion of Bacterial Mutations Test. ISO Standard 10993- 3:2014 (Biological Evaluation of Medical Devices, Part 3: Test for Genotoxicity, Carcinogenicity and Reproductive Toxicity) and OECD 471:1997 (Bacterial Reverse Mutation Test).

EC Certificate

Full quality assurance system according to Medical Devices Directive 93/42/EEC Annex-II Section 3. Certificate Number: 1984-MDD-20-675.