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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteins
Description
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteinsWhat is this standard about? This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen
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Annex ZA (informative) #Relationship between this Standard and the Essential Requirements of EU Directive 98/37/EC
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