11.100.01 - Laboratory medicine in general

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 includ...view more

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, accura...view more

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, acc...view more

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, accu...view more

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

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.

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 feed...view more

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 M...view more

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.
...view more

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 ...view more

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 2065...view more

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 e...view more

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 elem...view more

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 eleme...view more

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 molecula...view more

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...view more

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.

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.

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.