Name: DIN ISO 13022 E : 2014
Brand: DIN

MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)

Published date

28-07-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword National Annex NA (informative) - Correction of Figure B.1 National Annex NB (informative) - Bibliography 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 labelling 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 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

Defines 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.

DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
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
ISO 13408-7:2012	Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
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
DIN EN ISO 7010 E : 2012	GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 6:2014)
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