Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formal...
1 Scope
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests…
Petroleum and related products — Precision of measurement methods and results — Part 4: Use of stati...
This document specifies the process and methodology for the construction, operation, and maintenance of statistical control charts to assess if a laboratory's execution of a standard test method is in-statistical-control and how to establish and validate the 'in-statistical-control' status.
It specifies control charts that are most appropriate for ISO/TC 28 test methods where the…
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Valida...
This document gives the general requirements for validation and verification 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 IVD medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative…
Cross-country skis — Determination of mass and location of balance point
Specifies laboratory measurement methods for the characteristics mentioned above. If laboratory measurement data are determined and published by manufacturers, standard measurement procedures are recommended to ensure comparability.
Microbiology of food and animal feeding stuffs — Guidelines on preparation and production of culture...
ISO/TS 11133-1:2009 provides the general terminology related to quality assurance and specifies the minimum requirements for the preparation of culture media to be used for the microbiological analysis of products intended for human consumption or animal feeding.
It is also applicable to culture media to be used for the microbiological analysis of all kinds of water.
These requirements are…
Paints and varnishes — Corrosion protection of steel structures by protective paint systems — Part 6...
ISO 12944-6:2018 specifies laboratory test methods and test conditions for the assessment of paint systems for the corrosion protection of carbon steel structures.
The test results are intended to be considered as an aid in the selection of suitable paint systems and not as exact information for determining durability.
ISO 12944-6:2018 covers protective paint systems designed for application to…
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-0...
IEC 61010-2-030:2010 specifies safety requirements for testing and measuring circuits which are connected for test or measurement purposes to devices or circuits outside the measurement equipment itself. These include measurement circuits which are part of electrical test and measurement equipment, laboratory equipment, or process control equipment. The existence of these circuits in equipment…
Clean cookstoves and clean cooking solutions — Harmonized laboratory test protocols — Part 1: Standa...
This document is applicable to cookstoves used primarily for cooking or water heating in domestic, small-scale enterprise, and institutional applications, typically with firepower less than 20 kW and cooking vessel volume less than 150 l, excluding cookstoves used primarily for space heating. For solar cookstoves, the provisions of this document are applicable only for evaluating cooking power,…
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen...
This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination 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…
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Termin...
This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed…
