If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive.
Several new parts in the series have been developed which promote a new philosophy of biological evaluation (particularly parts 17,18 and 19).
BSI’s International standards also give requirements for the preparation, conduct and performance of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices.
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
