DIN ISO 13022 E : 2014
Current
The latest, up-to-date edition.
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
28-07-2014
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> of ISO 13022<br>Annex B (informative) - Graphic representation of the<br> part of the risk management process for cell-based<br> medical products<br>Annex C (normative) - Requirements for donor selection<br> and testing<br>Annex D (informative) - Guidance for tissue procurement<br>Annex E (normative) - Requirements for handling of cells<br> 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> contamination with viruses and other infectious agents<br> such as TSE<br>Annex K (informative) - Guidance with regard to hazards<br> caused by the tumorigenic potential the human<br> cells/tissues used for the production of medical products<br>Annex L (informative) - Guidance with regard to<br> microbiological contamination<br>Annex M (informative) - Guidance with regard to potential<br> adverse effects of non-cellular residues of the product<br>Annex N (normative) - Requirements with regard to potential<br> adverse effects of the cellular components of a<br> medical product<br>Annex O (informative) - Guidance for the characterization<br> of the cellular components of a medical product<br>Annex P (informative) - Clinical evaluation and testing<br>Bibliography
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