11.100.10 - In vitro diagnostic test systems
ICS 11.100.10 Details
In vitro diagnostic test systems
Systemes de diagnostic in vitro
Diagnostični preskusni sistemi in vitro
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This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
- Technical specification53 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft50 pagesEnglish languagesale 10% offe-Library read for1 day
The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
- Amendment17 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft17 pagesEnglish languagesale 10% offe-Library read for1 day
This standard EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use is classified in these ICS categories:
19.080 Electrical and electronic testing
71.040.10 Chemical laboratories. Laboratory equipment
11.040.55 Diagnostic equipment
IEC 61010-2-101:2015 is available as IEC 61010-2-101:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes:
- excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment;
- updated Biohazard and Lot symbols in Table 1 in Clause 5;
- added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5;
- added requirement for gas or liquid markings and ratings to Clause 5;
- added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5;
- added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5;
- added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5;
- added requirement for OPERATOR maintenance instructions to Clause 7;
- added requirements for sample zones and loading zones to Clause 7;
- excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8;
- added requirement for biohazard marking to Clause 13;
- added requirement for interlock systems containing electric/electronic or programmable components to Clause 15;
- added informative reference to Usability standard IEC 62366 to Clause 16;
- replaced Clause 17 with requirements of ISO 14971 for RISK assessment.
- Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft18 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test 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 genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2.
Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document.
NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9].
DNA in pathogens present in blood is not covered by this document.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for self-testing.
- Standard11 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). .
- Standard53 pagesEnglish languagesale 15% off
- Standard53 pagesFrench languagesale 15% off
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for self-testing.
- Standard10 pagesEnglish languagesale 15% off
- Standard11 pagesFrench languagesale 15% off
This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186 3.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification24 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft39 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification24 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft23 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesiclesduring the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous
whole blood collection tubes.
The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations 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 during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in prEN ISO 20186-3, Molecular in-vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma and CEN/PWI, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification30 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft30 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free RNA (ccfRNA) examinations during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations 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 during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/PWI, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — Isolated DNA, RNA and proteins, and in ISO 20186-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft25 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using IVD medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences. This document is intended as guidance for multiplex examinations that either detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research and regulatory authorities. This document is not applicable to metagenomics. NOTE An examination procedure developed for a laboratory’s own use is often referred to as a “laboratory developed test,” “LDT,” or “in-house test”.
- Standard15 pagesEnglish languagesale 15% off
- Standard16 pagesFrench languagesale 15% off
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in EN ISO 20186 3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma and CEN/TS 17742, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification30 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations 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 need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft25 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes acceptable performance criteria for antimicrobial susceptibility test
(AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to
antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of
such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation
studies.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft23 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for protein examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine proteins isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184 2, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins and EN ISO 20166 2, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins.
This document is not applicable for protein examination by immunohistochemistry.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft26 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184 3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA and EN ISO 20166 3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA.
This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification36 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft36 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine RNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA B) and are not covered in this document, but in ISO 20184-1, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 1: Isolated RNA and ISO 20166-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA.
RNA in pathogens present in FNA is not covered by this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft38 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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.
This document is not applicable for protein examination by immunohistochemistry.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft21 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for protein examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine proteins isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins and EN ISO 20166-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins.
This document is not applicable for protein examination by immunohistochemistry.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft26 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine RNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA.
This document is not applicable for RNA examination by in situ detection.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft38 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA.
This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification36 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft36 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing materiasl or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft16 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes a method for testing the susceptibility to antifungal agents of yeasts, including
Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here
has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis
and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds)
introduces several additional problems in standardization not addressed by the current procedure.
Those methods are beyond the scope of this document.
This document describes the broth micro-dilution reference method, which can be implemented by
either of two pathways. One pathway involves visual determination of MICs (CLSI method)[1][5]
; the
second pathway involves spectrophotometric determination of MICs (EUCAST method)[2][10]. The MIC
reflects the activity of the drug under the described test conditions and can be interpreted for clinical
management purposes by taking into account other factors, such as drug pharmacology or antifungal
resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild
type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document;
interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by
consulting the latest interpretive tables provided by the organizations[5][15]. Routine susceptibility
testing methods or diagnostic test devices can be compared with this reference method in order to
ensure comparable and reliable results for validation or registration purposes.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
This standard specifies requirements and test methods for single-use evacuated and non-evacuated
receptacles, intended by their manufacturers, for the primary containment and preservation of
specimens, other than blood specimens, derived from the human body, for the purposes of in vitro
diagnostic examination.
NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood
specimen containers are specified in EN ISO 6710.
NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous
discharge of the contents, when being opened, this standard does not specify a test procedure for this
because it has not been possible to devise an objective and reproducible test.
This standard does not specify requirements for collection needles or needle holders or other
accessories used in conjunction with specimen receptacles.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft18 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft16 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document.
This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)[1][5]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)[2][10]. The MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations[5][15]. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard12 pagesEnglish languagesale 15% off
- Standard14 pagesFrench languagesale 15% off
- Draft12 pagesEnglish languagesale 15% off
- Draft12 pagesFrench languagesale 15% off
This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document. This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)[1][5]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)[2][10]. The MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations[5][15]. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.
- Standard16 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off
- Draft16 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.
Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.
NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.
This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft18 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations. Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
- Standard14 pagesEnglish languagesale 15% off
- Standard15 pagesFrench languagesale 15% off
- Draft14 pagesEnglish languagesale 15% off
- Draft13 pagesFrench languagesale 15% off
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.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft31 pagesEnglish languagesale 10% offe-Library read for1 day
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO
DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific
aspects of this electrical equipment and their electromagnetic environment.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft15 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives 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, ISO 20166-2 and ISO 20166-3, 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.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives 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, ISO 20166-2 and ISO 20166-3, 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.
- Standard26 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Draft26 pagesEnglish languagesale 15% off
- Draft30 pagesFrench languagesale 15% off
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.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies technical requirements and documentation necessary to establish metrological
traceability of values assigned to calibrators, trueness control materials and human samples for
quantities measured by IVD MDs. The human samples are those intended to be measured, as specified
for each IVD MD. Metrological traceability of values for quantities in human samples extends to the
highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are
subject to the requirements described. These parties include but are not limited to manufacturers (of
IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration
laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include
commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs
and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of
a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratorydeveloped
MP.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio)
and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio
of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a
specified concentration or activity at the cut-off), or a counting scale, with corresponding decision
threshold(s). This also includes IVD MDs where results are categorized among ordinal categories
based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of
IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so
indicated in the RM’s intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be
used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when
the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known
to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to
assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing
changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories
and which are supplied with intervals of suggested acceptable values that are not metrologically
traceable to higher order reference system components;
d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types,
identity of nucleic acid sequences, identity of urine particles.
NOTE 3 Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g. ‘sick’
vs. ‘healthy’), and occasionally to results differentiated into non-dichotomous categories where the result
categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative
degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual
observation.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft60 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
NOTE 3
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft60 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives recommendations 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.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation.
This document is applicable to molecular in vitro diagnostic examinations 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 the pre-examination phase for infectious disease examination (eg. targeted pathogen identification). These are not described in this document.
Different dedicated measures are taken for the pre-examination phase of saliva for human genomic DNA examination. These are not described in this document but are covered in CEN WI00140116, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagesale 10% offe-Library read for1 day
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