BS EN ISO 10993-1 : 2009-10

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
  of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
  biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management
        process
Annex C (informative) - Suggested procedure for literature
        review
Bibliography
Annex ZA (informative) - Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices

Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.