ANSI/AAMI/ISO 13022:2012

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

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.