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11.100.30 - Analysis of blood and urine

ICS 11.100.30 Details

Analysis of blood and urine

Analiza krvi in urina

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Parent
11.100 - Laboratory medicine

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN ISO 20186-1:2019(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
EN ISO 20186-1:2019

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. 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.
Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.
RNA in pathogens present in blood is not covered by this document.

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SIST
SIST EN ISO 20186-2:2019(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
EN ISO 20186-2:2019

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. 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.
Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document.
NOTE       Circulating cell free DNA in blood is covered in ISO 20186-3.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.

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SIST
SIST EN ISO 15197:2015(Main)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
EN ISO 15197:2015

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

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CEN
CEN/TS 16835-3:2015(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
SIST-TS CEN/TS 16835-3:2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage.
Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
NOTE   CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4].
Pathogen DNA present in blood is not covered by this Technical Specification.

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CEN
CEN/TS 16835-2:2015(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
SIST-TS CEN/TS 16835-2:2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification.
Pathogen DNA present in blood is not covered by this Technical Specification.

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SIST
SIST-TS CEN/TS 16835-3:2015(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
CEN/TS 16835-3:2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage.
Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
NOTE   CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4].
Pathogen DNA present in blood is not covered by this Technical Specification.

  • Technical specification
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SIST
SIST-TS CEN/TS 16835-2:2015(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
CEN/TS 16835-2:2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification.
Pathogen DNA present in blood is not covered by this Technical Specification.

  • Technical specification
    21 pages
    English language
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SIST
SIST-TS CEN/TS 16835-1:2015(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
CEN/TS 16835-1:2015

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage.
Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification.
RNA in pathogens present in blood is not covered by this Technical Specification.

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    20 pages
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ISO
ISO/PAS 18873:1999(Main)
International protocol for doping control
  • Technical specification
    77 pages
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50