A Practical Guide to ISO 10993-3 | 合法醫療器材資訊網

Asdoseveralothersectionsoftheinternationalstandards,ISO10993-3refersreaderstotheOrganizationforEconomicCooperationandDevelopment(OECD)​ ...

Medical Device & Diagnostic Industry Magazine MDDI Article Index[1][2]

An MD&DI October 1998 Column

The growing concern that medical devices can contribute to changes in DNA structure is addressed in the standard on genotoxicity. Note: this article is part of an ongoing series on ISO 10993. The previous installment covered design of subchronic and chronic systemic toxicity tests[3].

Although measures of a medical products biocompatibility have largely been reported in terms of irritation, sensitization, and systemic toxicity, there is growing concern that devices, their components, or material extracts also may exert genotoxic effects. Thus, any attempt to assess the safety of a device intended for intimate body contact or permanent implantation would be incomplete without testing for the presence of toxins that exert an effect on ...