CWA 15849:2008 en

Coding of Information and Traceability of Human Tissues and Cells

  • Deze norm is ingetrokken sinds 04-08-2016


Over deze norm

Status Ingetrokken
Aantal pagina's 54
Gepubliceerd op 01-06-2008
Taal Engels
The background to this document is the DIRECTIVE 2004/23/EC (ECD), Article 25 provision requiring the Commission in cooperation with Member States to design a single European coding system to provide information on the main characteristics and properties of tissues and cells. This requirement is elaborated further in COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006 implementing DIRECTIVE 2004/23/EC. The present document therefore sets out the basic specification of a European coding system for human tissues and cells, and indicates how implementation of the system could be approached. The CWA analyses the following issues: - minimum requirement code systems to be used at European level; - the basic process of donation, evaluation, procurement, processing, storage and distribution of Tissues and Cells. - what a coding system can do; - biovigilance schemes (including a review of dependencies); - coding systems for human tissues and cells used in Europe; - how existing systems can be made compatible with the harmonised European system; - the implications of bringing local coding systems into the European system, and ways to resolve any difficulties; - guidelines for the use of the harmonised European system in Member States (including management rules, labelling and electronic / telematic means); - how the coding system should be maintained in the future. The background to this document is work already undertaken by the Expert Working Group of DG SANCO on coding of human tissues and cells established under Article 29 of the ECD. The document includes analysis of existing relevant public activities (both inside and outside standardisation and including R&D projects) at European, national, regional and international levels, and also takes due account of other relevant international activities. The document also contains a proposed programme of further actions, both inside and outside the standardisation environment. The draft and completed document, and the associated Workshop proposals and recommendations, was submitted to the Commission and to the Committee of Member States that assists its management process under article 29 of the ECD. Taking due account of the views expressed, as well as of the initial Workshop recommendations, the document may be progressed further towards a European (in CEN) or an International Standard (in ISO), and/or additional Workshop activities may be undertaken at later stages.


ICS-code 35.240.80
Nederlandse titel Coding of Information and Traceability of Human Tissues and Cells
Engelse titel Coding of Information and Traceability of Human Tissues and Cells



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