Table of Contents

Foreword <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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the part of the risk management process for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;cell-based 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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;cells and tissue during manufacture<br>Annex F (normative) - Requirements for packaging and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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 relating to <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination with viruses and other infectious <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;agents such as TSE<br>Annex K (informative) - Guidance relating to hazards caused <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by the tumorigenic potential of human cells or <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;tissues used for the production of medical products<br>Annex L (informative) - Guidance relating to microbiological <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination<br>Annex M (informative) - Guidance relating to potential adverse <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;effects of non-cellular residues of the product<br>Annex N (normative) - Requirements relating to potential <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;adverse effects of the cellular components of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a 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

Abstract

Describes 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194
Supersedes	ISO/DIS 13022 : 60.00 (2012)