This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.
Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage.
Different dedicated measures need to be taken for stabilising blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this International Standard.
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 or other technologies generating dried blood. These are not described in this International Standard.
RNA in pathogens present in blood is not covered by this International Standard.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by (e.g., medical laboratories. It is also intended to be used by, laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizsations 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 analysisexamination. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures have to be taken for preserving blood cell free circulating DNA, which are not described in this International Standard. Circulating cell free DNA in blood is covered in ISO 20091-3, 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, stabilizsing, 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 International Standard.
Pathogen DNA present in blood is not covered by this International Standard.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This International Standard 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.
This International Standard 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.
This International Standard does not:
— provide a comprehensive evaluation of all possible factors that could affect the performance of
these systems,
— pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
— address the medical aspects of diabetes mellitus management,
— apply to measurement procedures with measured values on an ordinal scale (e.g. visual,
semiquantitative measurement procedures), or to continuous glucose monitoring systems,
— apply to glucose meters intended for use in medical applications other than self-testing for the
management of diabetes mellitus

  • Standard
    57 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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
    sale 10% off
    e-Library read for
    1 day

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.

  • Technical specification
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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
    sale 10% off
    e-Library read for
    1 day
  • Technical specification
    77 pages
    English language
    sale 15% off