Laboratoriemedisin

Komité: ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems)
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Sluttdato: 13. sep 2020
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Komité: ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems)
Opprinnelse:
Sluttdato: 13. sep 2020
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Komité: CEN/TC 140 (In vitro diagnostic medical devices)
Opprinnelse:
Sluttdato: 14. sep 2020
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This document gives requirements for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for examinations of morphology and biomolecules, such as metabolites, proteins, DNA and/or RNA in situ on FFPE tissue sections by using different in situ detection techniques. This document is applicable to routine and molecular diagnostic examinations using in situ detection techniques including laboratory developed tests performed by routine pathology laboratories (histology laboratories) as well as molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, as well as institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. This document is not applicable for the examination of isolated biomolecules such as proteins, DNA and RNA that cannot be mapped with a defined region of a FFPE section. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Komité: CEN/TC 140 (In vitro diagnostic medical devices)
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Sluttdato: 14. sep 2020
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This document will describe pre-examination, examination and post-examination processes for medical laboratory examination of human semen. It is intended to be used for diagnostics in small and large medical laboratories performing semen analysis. Preparation of semen for therapeutic use is not included.
Komité: CEN/TC 140 (In vitro diagnostic medical devices)
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Sluttdato: 14. sep 2020
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This document covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. The document is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Komité: CEN/TC 140 (In vitro diagnostic medical devices)
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Sluttdato: 5. okt 2020
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This document gives recommendations for the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated DNA during the pre-examination phase before a molecular examination is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.