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ANSI/AAMI/ISO 13022:2012 - Medical products containing viable human cells-Application of risk management and requirements for processing practices >
ANSI/AAMI/ISO 13022:2012 - Medical products containing viable human cells-Application of risk management and requirements for processing practices, 2012
- ANSI/AAMI/ISO 13022:2012, Medical products containing viable human cells — Application of risk management and requirements for processing practices
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Table of contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of ISO 13022:2012
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Risk management process [Go to Page]
- Annex A (informative) Guidance on the application of ISO 13022 [Go to Page]
- 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 [Go to Page]
- Annex D (informative) Guidance for tissue procurement [Go to Page]
- Annex E (normative) Requirements for handling of cells and tissue during manufacture [Go to Page]
- Annex F (normative) Requirements for packaging and labeling [Go to Page]
- Annex G (informative) Guidance for transport [Go to Page]
- Annex H (informative) Guidance for storage [Go to Page]
- Annex I (normative) Requirements for traceability [Go to Page]
- Annex J (normative) Risk reduction measures relating to contamination with viruses and other infectious agents such as TSE [Go to Page]
- Annex K (informative) Guidance relating to hazards caused by the tumorigenic potential of human cells or tissues used for the production of medical products
- Annex L (informative) Guidance relating to microbiological contamination [Go to Page]
- Annex M (informative) Guidance relating to potential adverse effects of non-cellular residues of the product [Go to Page]
- Annex N (normative) Requirements relating to potential adverse effects of the cellular components of a medical product [Go to Page]
- Annex O (informative) Guidance for the characterization of the cellular components of a medical product [Go to Page]
- Annex P (informative) Clinical evaluation and testing
- Bibliography [Go to Page]