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ANSI/AAMI/ISO 13022:2012

Current
Current

The latest, up-to-date edition.

MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-18-2012

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.

Committee
ISO/TC 194
DocumentType
Standard
ISBN
1570204470
Pages
71
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 13022:2012 Identical

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO/TR 22442-4:2010 Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
ASTM F 2386 : 2004 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2149 : 2016 : REDLINE Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM F 2385 : 2015 : REDLINE Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ASTM F 2383 : 2011 : REDLINE Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
EN 166:2001 Personal eye-protection - Specifications
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ASTM F 2739 : 2016 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
EN 511:2006 Protective gloves against cold
ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 1251-3:2000 Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 3: Operational requirements
ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
EN 13458-3:2003/A1:2005 CRYOGENIC VESSELS - STATIC VACUUM INSULATED VESSELS - PART 3: OPERATIONAL REQUIREMENTS
ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place

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