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
General Information
Frequently Asked Questions
ICS 11.100.10 is a classification code in the International Classification for Standards (ICS) system. It covers "In vitro diagnostic test systems". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 261 standards classified under ICS 11.100.10 (In vitro diagnostic test systems). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document provides requirements and recommendations on the conditions (means of delivery) and minimum required information to deliver when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). The content of the eIFU is not in the scope of this standard, as it is covered by the documents in the ISO 18113 series.
- Standard6 pagesEnglish languagesale 15% off
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. This document applies to: RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties; any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard25 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty. This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1. When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM. Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard20 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and 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.
- Standard33 pagesEnglish languagee-Library read for1 day
- Amendment12 pagesEnglish languagee-Library read for1 day
This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and 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.
- Standard33 pagesEnglish languagee-Library read for1 day
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document specifies the control and approval of in vitro diagnostic reagents used in animal health for immunological analyses with a qualitative expression of test results.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies terms and definitions applicable to the EN 18000 series and requirements concerning information to be provided by applicants submitting animal health in vitro diagnostic reagents to control.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA. This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3. This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and 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 15% off
- Standard27 pagesFrench languagesale 15% off
This document specifies terms and definitions applicable to the EN 18000 series and requirements concerning information to be provided by applicants submitting animal health in vitro diagnostic reagents to control.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies the control and approval of in vitro diagnostic reagents used in animal health for immunological analyses with a qualitative expression of test results.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard15 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.
- Standard36 pagesEnglish languagee-Library read for1 day
This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.
This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
- Standard43 pagesEnglish languagee-Library read for1 day
This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.
This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
- Standard43 pagesEnglish languagee-Library read for1 day
This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions. It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories. The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling). While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms. This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories. This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
- Standard33 pagesEnglish languagesale 15% off
- Standard34 pagesFrench languagesale 15% off
- Standard34 pagesSpanish languagesale 15% off
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an 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 pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification24 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour 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 genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2.
This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification27 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from circulating tumour 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 ISO 20186-1.
This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification27 pagesEnglish languagee-Library read for1 day
This document provides guidance to manufacturers on the minimum requirements for the lifecycle management of in vitro diagnostic (IVD) medical devices that are developed in preparation for and in response to a public health emergency involving infectious agents requiring immediate availability of authorized IVD devices. NOTE This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes: — following a risk management process; — monitoring the device’s post-market performance and quality assurance; — implementing a communication system.
- Technical specification13 pagesEnglish languagesale 15% off
- Technical specification14 pagesSpanish languagesale 15% off
This document gives the general requirements for interpretation and reporting 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 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 examinations that detect or quantify human nucleic acid target sequences and microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular IVD examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomic massive parallel sequencing (MPS), but it is applicable to multiplex molecular methods including 16S sequencing.
- Standard14 pagesEnglish languagesale 15% off
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from circulating tumour 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 ISO 20186-1.
This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification27 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour 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 genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2.
This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification27 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an 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 pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification24 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour 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 genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2. This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells). NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification19 pagesEnglish languagesale 15% off
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an 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 pre-analytical workflow requirements for viable CTC cryopreservation and culturing. Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells). NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification16 pagesEnglish languagesale 15% off
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from circulating tumour 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 ISO 20186-1. This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells). NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification19 pagesEnglish 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).
.
- Standard65 pagesEnglish languagee-Library read for1 day
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.
- Standard22 pagesEnglish languagee-Library read for1 day
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.
- Standard24 pagesEnglish languagee-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.
- Standard21 pagesEnglish languagee-Library read for1 day
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.
- Standard24 pagesEnglish languagee-Library read for1 day
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).
.
- Standard65 pagesEnglish languagee-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.
- Standard21 pagesEnglish languagee-Library read for1 day
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.
- Standard24 pagesEnglish languagee-Library read for1 day
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.
- Standard22 pagesEnglish languagee-Library read for1 day
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.
- Standard24 pagesEnglish languagee-Library read for1 day
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.
- Standard72 pagesEnglish languagee-Library read for1 day
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.
- Standard72 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organisations performing biomedical research.
This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
- Technical specification64 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research.
This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
- Technical specification60 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research.
This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
- Technical specification60 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organisations performing biomedical research.
This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
- Technical specification64 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone.
4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.
4.3 The user is encouraged to use appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.
4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.
4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs, respectively.
4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.
SCOPE
1.1 This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment bone growth.
1.2 Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog (canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail.
1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).
1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.
1.5 Other preclinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide14 pagesEnglish language
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 languagee-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 languagee-Library read for1 day