11.100 - Laboratory medicine
ICS 11.100 Details
Laboratory medicine
Labormedizin
Medecine de laboratoire
Laboratorijska medicina
General Information
Frequently Asked Questions
ICS 11.100 is a classification code in the International Classification for Standards (ICS) system. It covers "Laboratory medicine". 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 900 standards classified under ICS 11.100 (Laboratory medicine). 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 specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard92 pagesEnglish languagee-Library read for1 day
This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies the general requirements intended to
protect the rights, safety and well-being of human subjects, users or other persons,
ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).
NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.
- Draft99 pagesEnglish languagee-Library read for1 day
This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K. EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Clause C.5[228]. NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.
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This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard92 pagesEnglish languagee-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard83 pagesEnglish languagesale 15% off
- Standard92 pagesFrench languagesale 15% off
This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies the general requirements intended to protect the rights, safety and well-being of human subjects, users or other persons, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s). NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.
- Standard85 pagesEnglish languagesale 15% off
- Standard85 pagesEnglish languagesale 15% off
- Standard91 pagesFrench languagesale 15% off
- Standard91 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
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
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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.
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This document provides supplemental information and guidance on how to implement the requirements listed in ISO 35001 [1]. This document does not add requirements to those in ISO 35001 [1].
- Technical specification139 pagesEnglish languagesale 15% off
This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971.
This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:
— a patient's body during intended use or reasonably foreseeable misuse; or
— the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks).
Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with:
— constituents of a medical device; and
— tissue-device interactions (including physical effects).
The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2).
This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices.
Other parts of the ISO 10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment.
For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO 10993 series and those provided in other standards. For example, the ISO 18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices.
The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document.
NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3.
NOTE 2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO 22442 series.
- Standard59 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 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 the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971.
This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:
— a patient's body during intended use or reasonably foreseeable misuse; or
— the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks).
Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with:
— constituents of a medical device; and
— tissue-device interactions (including physical effects).
The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2).
This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices.
Other parts of the ISO 10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment.
For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO 10993 series and those provided in other standards. For example, the ISO 18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices.
The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document.
NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3.
NOTE 2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO 22442 series.
- Standard59 pagesEnglish languagee-Library read for1 day
This document defines the core terms and definitions in the field of laboratory design.
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- Standard33 pagesFrench languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
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This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either: — a patient's body during intended use or reasonably foreseeable misuse; or — the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks). Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: — constituents of a medical device; and — tissue-device interactions (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see REF Section_sec_6.6.2 \r \h 6.6.2 08D0C9EA79F9BACE118C8200AA004BA90B020000000800000012000000530065006300740069006F006E005F007300650063005F0036002E0036002E0032000000 ). This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices. Other parts of the ISO 10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment. For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO 10993 series and those provided in other standards. For example, the ISO 18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices. The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document. NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3. NOTE 2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO 22442 series.
- Standard42 pagesEnglish languagesale 15% off
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- Standard46 pagesFrench languagesale 15% off
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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.
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This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
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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
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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 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, 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 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
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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 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