DIN ISO 13022 E : 2014

National foreword<br>National Annex NA (informative) - Correction of Figure B.1<br>National Annex NB (informative) - Bibliography<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Risk management process<br>Annex A (informative) - Guidance on the application<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of ISO 13022<br>Annex B (informative) - Graphic representation of the<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;part of the risk management process for cell-based<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;medical products<br>Annex C (normative) - Requirements for donor selection<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and testing<br>Annex D (informative) - Guidance for tissue procurement<br>Annex E (normative) - Requirements for handling of cells<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and tissue during manufacture<br>Annex F (normative) - Requirements for packaging and labelling<br>Annex G (informative) - Guidance for transport<br>Annex H (informative) - Guidance for storage<br>Annex I (normative) - Requirements for traceability<br>Annex J (normative) - Risk reduction measures related to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination with viruses and other infectious agents<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;such as TSE<br>Annex K (informative) - Guidance with regard to hazards<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;caused by the tumorigenic potential the human<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;cells/tissues used for the production of medical products<br>Annex L (informative) - Guidance with regard to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;microbiological contamination<br>Annex M (informative) - Guidance with regard to potential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;adverse effects of non-cellular residues of the product<br>Annex N (normative) - Requirements with regard to potential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;adverse effects of the cellular components of a<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;medical product<br>Annex O (informative) - Guidance for the characterization<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of the cellular components of a medical product<br>Annex P (informative) - Clinical evaluation and testing<br>Bibliography

Defines requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof.