Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (informative) - Guidance on the application
of ISO 13022
Annex B (informative) - Graphic representation of the
part of the risk management process for
cell-based medical products
Annex C (normative) - Requirements for donor selection
and testing
Annex D (informative) - Guidance for tissue procurement
Annex E (normative) - Requirements for handling of cells
and tissue during manufacture
Annex F (normative) - Requirements for packaging
Annex G (informative) - Guidance for transport
Annex H (informative) - Guidance for storage
Annex I (normative) - Requirements with regard to
traceability
Annex J (normative) - Risk Reduction Measures Related
to Contamination with Viruses and Other Infectious
Agents such as TSE
Annex K (informative) - Guidance with regard to hazards
caused by the tumorigenic potential of the human
cells/tissues used for the production of medical
products
Annex L (informative) - Guidance with regard to microbiological
contamination
Annex M (informative) - Guidance with regard to potential adverse
effects of non-cellular residues of the product
Annex N (normative) - Requirements with regard to potential
adverse effects of the cellular components of a
medical product
Annex O (informative) - Guidance for the characterisation
of the cellular components of a medical product
Annex P (informative) - Clinical evaluation and testing
Bibliography