This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation. This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA). This document does not apply to the post-vasectomy assessments. NOTE      Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).

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This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for the pre-examination phase for infectious disease examination (eg. targeted pathogen identification). These are not described in this document.
Different dedicated measures are taken for the pre-examination phase of saliva for human genomic DNA examination. These are not described in this document but are covered in CEN WI00140116, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.

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EN-ISO 22367 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 and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and 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 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

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  • Standard
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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 and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and 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 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

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  • Standard
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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 and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and 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 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

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This document specifies requirements for safe practices in the medical laboratory (herein after referred to as "the laboratory").

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This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.

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This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.

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This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request. NOTE See Annex B for an example of application of the MU.

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This document specifies the requirements for competence to carry out reference measurement
procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative
reference and listing additional requirements for calibration laboratories to perform their tasks
adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in
Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].

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This document specifies requirements and good practice recommendations for the collection, transport,
receipt and handling of samples intended for medical laboratory examinations.
This document is applicable to medical laboratories and other medical services involved in laboratory
pre-examination processes that include the examination request, patient preparation and identification,
sample collection, transport, receipt and storage. It may also be applicable to some biobanks.
This document does not apply to blood and blood products intended for transfusion.

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ISO/TS 20658:2017 specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations. ISO/TS 20658:2017 is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection, transport, receipt and storage. It may also be applicable to some biobanks. ISO/TS 20658:2017 does not apply to blood and blood products intended for transfusion.

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This document gives specific requirements applicable to point-of-care testing and is intended to be
used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried
out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document
can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of
physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be
applicable.
NOTE Local, regional and national regulations are to be taken into consideration.

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ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.

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ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.

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ISO/TS 17518:2015 provides requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology. This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory disciplines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology.

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ISO/TS 17822-1:2014 is intended for ? IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and ? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens. This part of ISO/TS 17822 does not apply to ? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or ? quantitative nucleic acid-based in vitro diagnostic examination procedures.

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This International Standard specifies requirements for quality and competence in medical laboratories. This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.

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ISO 13132:2011 specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.

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ISO 13132:2011 specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.

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ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.

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ISO 24998:2008 specifies requirements and test methods for plain, single-use Petri dishes for microbiological use. ISO 24998:2008 does not apply to products of similar design which may be used for cell or tissue culture purposes. Neither does it apply to dishes supplied ready loaded with microbiological media.

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This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
NOTE    International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.

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This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.

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Flow-out and blow-out pipettes are considered. They will only be expected to provide their specified performance during the original operation. The requirements deal with the basis of adjustment, dimensions, delivery time and construction. The determination of accuracy and repeatability and the marking are specified.

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This document will describe pre-examination, examination and post-examination processes for medical laboratory examination of human semen. It is intended to be used for diagnostics in small and large medical laboratories performing semen analysis. Preparation of semen for therapeutic use is not included.

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This document will describe pre-examination, examination and post-examination processes for medical laboratory examination of human semen. It is intended to be used for diagnostics in small and large medical laboratories performing semen analysis. Preparation of semen for therapeutic use is not included.

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This Technical Specification characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. This Technical Specification proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.

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This European Standard describes the principles which guide the selection of equipment to be used in a biotechnology laboratory.

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ISO/TS 22367:2008 characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.

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This standard describes the specific requirements for reference measurement laboratories in laboratory medicine. NOTE 1 It is the laboratory's responsibility to comply with the relevant legal health and safety requirements. NOTE 2 It is understood that reference measurement procedures should be of high metrological order and the analytical principle of measurement applied should allow an adequately low uncertainty. The results of reference measurements should be, if possible, traceable to reference materials or to a reference procedure of higher order.

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This International Standard gives specific requirements applicable to point-of-care testing and is intended to be used with ISO  15189. The requirements of this standard apply when POCT is carried out in a  hospital or clinic and may be applied by a  healthcare organization providing  ambulatory care. It may be applied to transcutaneous measurements, the analysis of expired air, and in vivo  monitoring of physiological parameters.  Patient self-testing in a home or community  setting is excluded, but elements of this  standard may apply. Considerations of local, regional, and national regulations  shall apply.

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This International Standard specifies requirements for quality and competence particular to medical laboratories. This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

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ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

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ISO/TS 22367:2008 characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.

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It is suggested that it is stated in the Scope that the Standard can be used for accreditation of medical laboratories specialised in the aspects mentioned. It should be clarified whether fulfilment of the requirements put forward in the present Standard will be valid also in a 9000 certification of the organisation to which the laboratory belongs, e.g. a hospital.

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ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

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ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. It can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of ISO 22870:2006 can be applicable.

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ISO/TR 22869:2005 provides guidance to medical laboratories describing how a medical laboratory can implement a quality system to meet the specific technical and management requirements for quality and competence in ISO 15189:2003. Bodies engaged in the recognition of the competence of medical laboratories may also be able to use ISO/TR 22869:2005 as a basis to assist laboratories in establishing a quality system to meet national requirements, while at the same time conforming to appropriate International Standards. This guidance applies both to newly established and existing laboratories and encompasses both the management and technical requirements of ISO 15189:2003.

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ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.

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ISO 15189:2003 specifies requirements for quality and competence particular to medical laboratories.

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