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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…

IEC TS 62271-304:2019 applies to indoor enclosed switchgear and controlgear complying with IEC 62271-200 and IEC 62271-201, intended to be used in special service conditions with respect to condensation and pollution deviating from the normal service conditions specified in IEC 62271-1. The test detailed in this document has been designed primarily to classify the electrical insulation…

This document specifies a protocol to identify ecotoxicological test specimens (mainly invertebrates and plants) to the species level, based on the DNA barcoding technique. This protocol can be used by laboratories performing DNA barcoding in order to standardize both the wet-lab and data analysis workflows as much as possible, and make them compliant with community standards and guidelines. This…

This document specifies a method for the determination of gross alpha and gross beta activity concentration for alpha- and beta-emitting radionuclides. Gross alpha and gross beta activity measurement is not intended to give an absolute determination of the activity concentration of all alpha and beta emitting radionuclides in a test sample, but is a screening analysis to ensure particular…

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination…

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination…

IEC 61010-2-091:2019 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 61010-2-091:2019 specifies particular safety requirements for cabinet X-ray systems, which fall under any of…

IEC 61010-2-091:2019 specifies particular safety requirements for cabinet X-ray systems, which fall under any of categories a), b) or c) below. a) Electrical test and measurement equipment This is equipment which by electromagnetic means tests, measures, indicates or records one or more electrical or physical quantities, also non-measuring equipment such as signal generators, measurement…

This document describes a test method to determine the average depth of pavement surface macrotexture (see Clause 3) by measuring the profile of a surface and calculating the texture depth from this profile. The technique is designed to provide an average depth value of only the pavement macrotexture and is considered insensitive to pavement microtexture and unevenness characteristics. The…

This document specifies a method for the determination of gross alpha and gross beta activity concentration for alpha- and beta-emitting radionuclides using liquid scintillation counting (LSC). The method is applicable to all types of waters with a dry residue of less than 5 g/l and when no correction for colour quenching is necessary. Gross alpha and gross beta activity measurement is not…