PD ISO/TR 15499:2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Biological evaluation as a risk management
  practice
5 Guidance on risk management
6 Guidance on specific aspects of biological
  evaluation
Bibliography

Pertains to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

This document is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO10993-1. It does not add to, or otherwise change, the requirements of ISO10993-1. 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, non-active, implantable and non-implantable medical devices.