- Palabras clave > availability, affordability, quality and safety - medical devices
- Palabras clave > bio-medical materials and engineering
- Palabras clave > biocompatibility testing
- Palabras clave > biomaterials - biocompatibility testing laboratory
- Palabras clave > biomedical technology
- Palabras clave > laboratory testing
- Palabras clave > medical devices - safety
- Palabras clave > medical devices - testing laboratory/facility
- Palabras clave > medical devices (MD)
- Palabras clave > toxicology
(2015; 49 pages)
Medical Implants form an important and a distinct category within the medical devices, from dental filling to pacemakers, medical implants encompass a board and complex variety of technologies that have been developed over decades and which are continuously evolving and becoming better. Complexity of implants increases further as these remain inside the body of the patient for many years, unlike most other medical devices that come in contact with the body either once or only a few times. In order to comply with all safety requirement, sets of universal standards and norms have been prescribed for biomaterials and biocompatibility.
The utility in terms of safety, effectiveness and performance for such compliance can be established through testing. The product testing, therefore, is the first level of assessment of appropriateness of an implant. Implants have a very broad range and so do the testing requirements to establish their safety. However, common set of prescribed tests and standards can be used for most Implants. This report essentially brings out the basic requirements, work flow, infrastructure and human resources required for establishing medical devices testing laboratory/facility for testing of biomaterials and Implants.