11.100.01 – Laboratory medicine in general – PDF Standards Store ?u= Wed, 06 Nov 2024 01:35:01 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 ?u=/wp-content/uploads/2024/11/cropped-icon-150x150.png 11.100.01 – Laboratory medicine in general – PDF Standards Store ?u= 32 32 ISO/TS 5798:2022 ?u=/product/publishers/iso/iso-ts-57982022/ Wed, 06 Nov 2024 01:35:01 +0000 In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Published By Publication Date Number of Pages
ISO 2022-04 52
]]> 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.

]]> ISO/TS 22583:2019 ?u=/product/publishers/iso/iso-ts-225832019/ Wed, 06 Nov 2024 01:33:08 +0000 Guidance for supervisors and operators of point-of-care testing (POCT) devices
Published By Publication Date Number of Pages
ISO 2019-11 42
]]> 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.

]]> ISO/TS 22367:2008 ?u=/product/publishers/iso/iso-ts-223672008/ Wed, 06 Nov 2024 01:32:56 +0000 Medical laboratories — Reduction of error through risk management and continual improvement
Published By Publication Date Number of Pages
ISO 2008-05 18
]]> 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.

]]> ISO/TS 20914:2019 ?u=/product/publishers/iso/iso-ts-209142019/ Wed, 06 Nov 2024 01:31:23 +0000 Medical laboratories — Practical guidance for the estimation of measurement uncertainty
Published By Publication Date Number of Pages
ISO 2019-07 80
]]> 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.

]]> ISO/TS 20658:2017 ?u=/product/publishers/iso/iso-ts-206582017/ Wed, 06 Nov 2024 01:31:15 +0000 Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
Published By Publication Date Number of Pages
ISO 2017-10 44
]]> 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.

]]> ISO/TS 17518:2015 ?u=/product/publishers/iso/iso-ts-175182015/ Wed, 06 Nov 2024 01:28:55 +0000 Laboratoire de biologie médicale — Réactifs pour la coloration de matériel biologique — Directives pour les utilisateurs
Published By Publication Date Number of Pages
ISO 2015-04 24
]]> L'ISO/TS 17518:2015 fournit des exigences et des directives pour la sélection et l'évaluation de la qualité de réactifs de coloration devant être utilisés en biologie pour la réalisation de diagnostics in vitro.

L'ISO/TS 17518:2015 s'applique à l'usage professionnel de réactifs de coloration en biologie par des laboratoires de biologie médicale; elle vise notamment les personnes chargées de l'approvisionnement et de l'évaluation de ces réactifs pour diverses disciplines de la biologie médicale, telles que la cytologie, l'hématologie, l'histopathologie, la microbiologie et la biologie moléculaire cliniques.

]]> ISO/TR 22869:2005 ?u=/product/publishers/iso/iso-tr-228692005/ Wed, 06 Nov 2024 01:16:07 +0000 Medical laboratories — Guidance on laboratory implementation of ISO 15189: 2003
Published By Publication Date Number of Pages
ISO 2005-02 24
]]> 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.

]]> ISO 7713:1985 ?u=/product/publishers/iso/iso-77131985/ Tue, 05 Nov 2024 23:59:45 +0000 Verrerie de laboratoire — Pipettes sérologiques à usage unique
Published By Publication Date Number of Pages
ISO 1985-05 8
]]> 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.

]]> ISO 35001:2019 ?u=/product/publishers/iso/iso-350012019/ Tue, 05 Nov 2024 23:06:42 +0000 Biorisk management for laboratories and other related organisations
Published By Publication Date Number of Pages
ISO 2019-11 36
]]> 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.

]]> ISO 24998:2008 ?u=/product/publishers/iso/iso-249982008/ Tue, 05 Nov 2024 22:49:18 +0000 Matériel de laboratoire en matière plastique — Boîtes de Petri à usage unique pour méthodes microbiologiques
Published By Publication Date Number of Pages
ISO 2008-11 16
]]> L'ISO 24998:2008 spécifie les exigences et les méthodes d'essai relatives aux boîtes de Petri simples, à usage unique en microbiologie.

L'ISO 24998:2008 n'est pas applicable aux produits de conception similaire pouvant être utilisés pour la culture de cellules ou de tissus. Elle ne s'applique pas non plus aux boîtes fournies préalablement remplies de milieux microbiologiques.

]]>