20/30379067 DC - BS EN ISO 20166-4. Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Part 4. In situ detection techniques

20/30379067 DC

BS EN ISO 20166-4. Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Part 4. In situ detection techniques

Status : Current, Draft for public comment   Published : July 2020

Format
PDF

Format
HARDCOPY



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.




Standard Number20/30379067 DC
TitleBS EN ISO 20166-4. Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Part 4. In situ detection techniques
StatusCurrent, Draft for public comment
Publication Date13 July 2020
Normative References(Required to achieve compliance to this standard)ISO/IEC 17020, ISO 15189, ISO 15190
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsISO/DIS 20166-4
Draft Expiry Date05 September 2020
DescriptorsMedical sciences, Laboratory testing, Quality, Quality assurance systems, Laboratories, Medical laboratory equipment, Quality assurance, Management, Laboratory accreditation, Medical technology, Quality management
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro -- Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) Partie 4: Techniques de détection in situ
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages33
File Size554 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Worldwide Standards
We can source any standard from anywhere in the world


BSOL

The faster, easier way to work with standards