10/30203224 DC : 0
Current
The latest, up-to-date edition.
BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
Hardcopy , PDF
English
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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
Annex G (informative) - Guidance for transport
Annex H (informative) - Guidance for storage
Annex I (normative) - Requirements with regard to
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 characterisation
of the cellular components of a medical product
Annex P (informative) - Clinical evaluation and testing
Bibliography
| Committee |
RGM/1
|
| DocumentType |
Draft
|
| Pages |
58
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| ASTM F 2386 : 2004 | Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013) |
| 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 |
| BS PAS 84(2008) : 2008 | REGENERATIVE MEDICINE - GLOSSARY |
| 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 |
| 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 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| EN 166:2001 | Personal eye-protection - Specifications |
| ASTM F 2739 : 2016 | Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| 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 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 |
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