Why need of Medical Device Quality Management System is Important?
What is ISO 10993?
The ISO 10993 series of standards address the biological evaluation, or biocompatibility, of medical devices based on material, contact type and duration. These standards cover a range of biological safety scenarios and stipulate what specific evaluations must be completed. Biocompatibility testing must be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025.
Why is biocompatibility testing important?
Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. In addition to the beneficial tissue response and the clinically relevant performance of a biomaterial, cytotoxicity, genotoxicity, mutagenicity, carcinogenicity and immunogenicity are considered to be the components which constitute “biocompatibility”.
What is ISO 10993 tests for in vitro cytotoxicity?
ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices.
What is ISO 10993-10 2010 tests for irritation and skin sensitization?
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.