Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process LONG_TITLE Those involved in the planning

Those involved in the planning and implementation of developments and infrastructure projects

and includes the requirements for four environmental classes covering applications in internal and outdoor locations as specified in BS EN 50130-5

BS EN ISO 6506-4:2005 Metallic materials

This enables the following:

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process LONG_TITLE Those involved in the planning1 Scope This document is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993 1. It does not add to, or otherwise change, the requirements of ISO 10993 1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active,