Laboratorní medicína, klinická patologie a biologická bezpečnost

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 5.09.2020
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This document gives requirements and recommendations 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 qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.

This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities.

This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1, -2 and -3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively.

Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively.

NOTE     International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 5.09.2020
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This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.

This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).

This document does not apply to the post-vasectomy assessments.

NOTE       Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 5.09.2020
Zobraz více Zobraz méně
 

This document specifies requirements for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.