S.R. CWA 15849:2008

Foreword
Introduction and Executive Summary
1 Scope
2 Normative references
3 Definitions, symbols and abbreviations
   3.1 Definitions
   3.2 Abbreviations
4 Legal and regulatory position
   4.1 EU Directives
5 Uses of a coding and traceability system
   5.1 General considerations regarding coding systems
        5.1.1 What is a coding system?
        5.1.2 Is a coding system a nomenclature?
        5.1.3 What is a coding management system?
        5.1.4 What is a database?
        5.1.5 Where does 'symbology' fit?
   5.2 Unique identification
   5.3 Traceability
   5.4 Biovigilance links
   5.5 Product Description
   5.6 Facilitating Reporting Requirements
   5.7 Overcome language barriers
   5.8 Supporting regulatory/ethical control with
        better source tracing
   5.9 Disadvantages to traceability
6 Previous work by the Tissue and Cells Regulatory
   Committee Expert Working Group
   6.1 Background
   6.2 Code structure proposal by the DG SANCO
        Tissue and Cells Regulatory Committee Expert
        Working Group
        6.2.1 Code structure sub team conclusions
        6.2.2 Summary of DG SANCO Tissue and Cells Regulatory
               Committee Expert Working Group
   6.3 Conclusions on the DG SANCO Tissue and Cells
        Regulatory Committee Expert Working Group
7 Factors to be taken into account
   7.1 Interpretation of scope
   7.2 Definition of a donation and location
   7.3 Global nature of transplantation
   7.4 Import/export of start or final product
   7.5 Technological aspects
        7.5.1 General considerations
        7.5.2 Labelling
        7.5.3 User interface
        7.5.4 Batches and tracing constituent elements
               7.5.4.1 Example models representing aspects
                       of material and process information
        7.5.5 Effect of short term solutions on long
               term planning
        7.5.6 Interface between tissues, cells, organs,
               other materials of human origin &
               advanced therapies
        7.5.7 Financial issues relating to tissue & cell
               sufficiency
   7.6 Political and philosophical issues
   7.7 Private public interface
   7.8 Complexities
8 Consultation with workshop participants regarding
   ranking of factors to be taken into account
   8.1 Background
   8.2 Ranking of factors
   8.3 Conclusions from questionnaire
   8.4 Importance of factors considered
9 Survey of coding systems in use and development in Europe
   9.1 Objective of study
   9.2 Scope of this survey
   9.3 Horizon scan of existing systems
   9.4 Conclusions relating to the survey of existing systems
10 Analysis of codes as candidates for all or part of
   the European Coding System
   10.1 Selection of candidate systems
   10.2 Self-assessment questionnaire
   10.3 Self assessment responses
   10.4 Selection of the appraisal panel
   10.5 Candidate codes
   10.6 Specification for analysis of candidate codes
        10.6.1 Assessment questions structured and
               applied to all three presented systems
   10.7 Presentations
   10.8 Panel analysis
11 Conclusions from evaluation of submitted
   coding systems
   11.1 Options originally proposed (but rejected)
   11.2 Options appraisal
   11.3 Augmenting the ISBT 128 code
        11.3.1 Background
        11.3.2 The donation number
        11.3.3 The key code
        11.3.4 How the key code might support different
               traceability regimes
        11.3.5 Product codes
   11.4 Traceability system
12 Recommendations
   12.1 Variation 1: Use "key code" together with ISBT 128
   12.2 Variation 2: Retain current donation identification
        but migrate to ISBT 128 product codes
   12.3 Variation 3: Retain current donation and product
        codes in each country or establishment, and
        add "key code"
   12.4 Recommended actions
13 Use of ISBT 128 in the European Tissue and
   Cell sectors
   13.1 Relationships to Competent Authorities
   13.2 Commercial standing
   13.3 Professional and geographical rivalries
14 Implementation recommendations
   14.1 Background
   14.2 EU implementation Recommendations
   14.3 MS implementation considerations
   14.4 EU coordination
        14.4.1 Proposals
        14.4.2 EC harmonisation Committee
        14.4.3 Key code development
        14.4.4 Product nomenclature development
        14.4.5 Relationships with ICCBBA
   14.5 Traceability system
   14.6 Phased implementation
   14.7 Costs
   14.8 Operational infrastructure and training for
        implementation of the EU Tissue and Cells
        Coding System
   14.9 Labelling
        14.9.1 Proposals
        14.9.2 Bio-hazard
        14.9.3 Re-labelling
        14.9.4 Import and re-labelling
        14.9.5 Label layout guidance - what and where
        14.9.6 Existing stock inventory during transition
        14.9.7 RFID implications for consideration
        14.9.8 Manual versus electronic code reading
               Informative References and Bibliography
               References
Bibliography

Describes the basic specification of a European coding system for human tissues and cells, and indicates how implementation of the system could be approached.