Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous...
1 Scope
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…
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous...
1 Scope
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…
Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
This document specifies requirements for the biobanking of bacteria and archaea. It includes management of microbial material associated data as well as biosafety and biosecurity requirements.
This document is applicable to all organizations performing biobanking with bacteria and archaea used for research and development.
This document does not apply to processing methods for microbial materials…
Nanotechnologies — Toxicity assessment and bioassimilation of manufactured nano-objects in suspensio...
This document provides a reliable and repeatable method for simultaneous assessment of both exposure and toxicity of manufactured nano-objects (MNOs) using Tetrahymena sp. The ingested, internalized material (MNOs) indicates aquatic exposure.
This document is intended to be used by all the centers working with nano(eco)toxicity of MNOs and capable of culturing of Tetrahymena sp. The method uses…
Conveyor belts — Laboratory scale flammability characteristics — Requirements and test method
This document specifies a method for assessing, on a small scale, the reaction of a conveyor belt to an ignition flame source. It is applicable to conveyor belts having a textile carcass as well as steel cord conveyor belts.
In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute re...
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…
Soil quality — In situ caging of snails to assess bioaccumulation of contaminants
This document describes a method to assess the bioaccumulation of chemicals in snails, i.e. concentrations of metal(loid)s (ME) or organic compounds [e.g. polycyclic aromatic hydrocarbons (PAHs) and polychlorinated biphenyls (PCBs)] accumulated in their tissues.
This document presents how to prepare snails for caging in situ for 28 days, the in situ test design and then how to collect and prepare…
Nanotechnologies — High throughput screening method for nanoparticles toxicity using 3D model cells
This document describes a method for high throughput evaluation of cytotoxic response of 3D model cells exposed to NPs without optical interference.
The method in this document is intended to be used in biological testing laboratories that are competent in the culture and growth of cells and the evaluation of cytotoxicity of NPs using 3D-model cells.
This method applies to materials that consist…
Neutron reference radiations fields — Part 1: Characteristics and methods of production
This document specifies the neutron reference radiation fields, in the energy range from thermal up to 20 MeV, for calibrating neutron-measuring devices used for radiation protection purposes and for determining their response as a function of neutron energy.
This document is concerned only with the methods of producing and characterizing the neutron reference radiation fields. The procedures for…
Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formali...
This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on…
