NEN EN ISO 22442-1 : 2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
  4.1 General
  4.2 Risk analysis
  4.3 Risk evaluation
  4.4 Risk control
  4.5 Evaluation of overall residual risk acceptability
  4.6 Production and post-production information system
Annex A (informative) - Guidance on the application of this
                        part of ISO 22442
Annex B (informative) - Graphical representation of part of
                        the risk management process for medical
                        devices utilizing animal material
Annex C (normative) - Special requirements for some animal
                      materials considering the risk management
                      for TSE agents
Annex D (informative) - Information relevant to the management
                        of TSE risk
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC as amended by
                         Commission Directive 2003/32/EC
Bibliography

Pertains to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered nonviable.