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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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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.

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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. NOTEÂ Â Â Â Â Â Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISOÂ 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (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 molecular assays that 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 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. 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".

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This document describes one reference method, broth micro-dilution, for determination of MICs.
The MIC can be a guide for the clinician, and reflects the activity of the drug under the described
test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics,
or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S),
“intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type
or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond
the scope of this document, modifications of the basic method are required for certain antimicrobial
agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a
separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g.
disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure
comparable and reliable results.

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This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand. This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples. NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.

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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 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.

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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.
This document 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, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover specific staining procedures.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) 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. 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 does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1.
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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) 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. 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 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) 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. 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 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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  • Technical specification
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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.
This document 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, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover specific staining procedures.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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  • Technical specification
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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) 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. 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 does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1.
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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) 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.
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). Therefore, special measures have to be taken to secure good quality blood samples for ccfDNA examination and storage.
Different dedicated measures need to be taken for preserving blood genomic DNA, which are not described in this International Standard. Blood genomic DNA is covered in ISO 20185-2, 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.
Pathogen DNA present in blood is not covered by this International Standard.
Different dedicated measures need to be taken for preserving DNA in circulating exosomes, which are not described in this International Standard.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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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.

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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.

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This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

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  • Standard
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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.

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  • Standard
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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.

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This International Standard recommends 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 International Standard 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, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.
This document is not applicable for protein examination by immunohistochemistry.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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This International Standard recommends 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 International Standard 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, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities.
The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the examination test results.
RNA profiles in tissues can change drastically during collection and change differently in different tissue donors' / patients' tissues. Therefore, it is essential to take special measures to minimize the described RNA profile changes and modifications within the tissue for subsequent examination.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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This International Standard recommends 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 International Standard 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, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities.
DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles. These modifications of the DNA molecules can impact the validity and reliability of the examination test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA examination.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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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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  • Standard
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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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  • Standard
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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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  • Standard
    21 pages
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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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This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of extracted proteins during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities.
Protein profiles and protein-protein interactions in tissues can change drastically before tissue collection (e.g., due to warm ischemia) and after tissue collection (e.g., due to cold ischemia). The changes are caused by e.g., gene induction, gene down regulation, protein degradation. Protein species amounts can change differently in different donors’ / patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environmental conditions after the tissue removal from the body.
Therefore, it is essential to take special measures to minimize the described protein profile changes and modifications within the tissue for subsequent examination.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable to protein examination by immunohistochemistry.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities.
RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues.
Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA examination.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE   International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.

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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.

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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.

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This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination 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 RNA extracted 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.
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.

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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.

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