ANSI/AAMI/ISO 13022:2012
Current
The latest, up-to-date edition.
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
Hardcopy , PDF
English
18-06-2012
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 13022:2012
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 and
labeling
Annex G (informative) - Guidance for transport
Annex H (informative) - Guidance for storage
Annex I (normative) - Requirements for 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 characterization
of the cellular components of a medical product
Annex P (informative) - Clinical evaluation and testing
Bibliography
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