DIN ISO 13022:2014
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)

Standard No.

DIN ISO 13022:2014

Release Date

2014

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN ISO 13022:2014-06

Latest

DIN ISO 13022:2014-06

Replace

DIN ISO 13022:2013

DIN ISO 13022:2014 Referenced Document

• ASTM F2027-08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products*， 2023-12-21 Update
• ASTM F2149-01 Standard Test Method for Automated Analyses of Cells8212;the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions*， 2023-12-21 Update
• ASTM F2210-02 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products*， 2023-12-21 Update
• ASTM F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs) *， 2023-12-21 Update
• ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical Products*， 2023-12-21 Update
• ASTM F2383 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)*， 2023-12-21 Update
• DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); English version of DIN EN ISO 22442-1:2008-03
• DIN EN ISO 22442-2:2008 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); English version of DIN EN ISO 22442-2:2008-03
• DIN EN ISO 22442-3:2008 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 22442-3:2007); English version of DIN EN ISO 22442-3:2008-0
• DIN EN ISO 7010:2012 Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO 7010:2011); German version EN ISO 7010:2012

DIN ISO 13022:2014 history

• 2014 DIN ISO 13022:2014-06 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
• 2014 DIN ISO 13022:2014 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
• 1970 DIN ISO 13022 E:2013-07
• 0000 DIN ISO 13022:2013