We have acquired a cerificate for ISO 13485 (special Q/A rules for the medical industry that include basic Q/A rules of ISO 9001/2000) with reference to ISO 11137 (rules for validation of products). ISO 11137 also includes standards EN 552 (rules for irradiation) and EN 556 (definition of the term sterility). The system will also be compatible with the FDA 21 CFR Part 820 QS Reg. GMP. The certification company is Bureau Veritas Denmark.
The installation qualification (ISO 11137) has been conducted by Dr. Arne Miller as the head of the High Dose Reference Laboratory in Risö, Denmark.