Sia Analiz
Developmental Toxicity
Reproductive developmental toxicity tests include studies evaluating the potential effects of medicinal materials and/or their extracts on fertility, reproductive function, and prenatal and postnatal early development within the scope of ISO 10993-3 standard. It should especially be considered for medical devices that have permanent contact with internal tissues and organs for which the risk of reproductive and developmental toxicity cannot be excluded or for which no information is available. For reproductive developmental toxicity tests, firstly the OECD 421 guideline is taken into account.
The same standard has emphasized the quality documentation of the laboratory where the reproductive developmental toxicity tests are to be carried out within the scope of the ISO 10993-3 standard. Reproductive developmental toxicity tests are carried out by expert personnel in SIA Analysis Laboratories, which have a GLP Declaration of Conformity.
