• There are no items in your cart

10/30203224 DC : 0

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

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ASTM F 2386 : 2004 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)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
EN 13458-3:2003/A1:2005 CRYOGENIC VESSELS - STATIC VACUUM INSULATED VESSELS - PART 3: OPERATIONAL REQUIREMENTS

View more information
US$23.96
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.