BS ISO 19007:2018 pdf download

BS ISO 19007:2018 pdf download

BS ISO 19007:2018 pdf download.Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles
1 Scope
This document specifies a method for evaluating the effects of nano-objects and their aggregates and agglomerates (NOAA) on cellular viability using the MTS assay. The assay design includes performance requirements and control experiments to identify and manage variability in the assay results.
This document is applicable to the use of a 96-well plate.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/TS 80004-2, Nanotechnologies — Vocabulary — Part 2: Nano-objects
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/TS 80004-2 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at
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3.1 culture vessel
example assay vessel described in this document based a 96-well tissue culture-grade plate format
Note 1 to entry: Other tissue culture grade vessels (i.e. 384 well plates, 24 well plates, 6 well plates) can be used interchangeably in these methods provided that they meet the requirements of tissue culture grade and are suitable for use with mammalian cells.
Note 2 to entry: Adjustments to the protocol such as cell seeding volumes, cell rinsing volumes, and cell dosing volumes may be required if other tissue culture grade vessels are used during this procedure.
[SOURCE: ISO 10993-5:2009, 3.1]
3.2 dispersion
microscopic multi-phase system in which discontinuities of any state (solid, liquid or gas: discontinuous phase) are dispersed in a continuous phase of a different composition or state
Note 1 to entry: If solid particles are dispersed in a liquid, the dispersion is referred to as a suspension. If the dispersion consists of two or more liquid phases, it is termed an emulsion. A superemulsion consists of both solid and liquid phases dispersed in a continuous liquid phase.
5.1 Cell line
Established cell lines are preferred and where used shall be obtained from recognized repositories. Follow the basic principles of cell culture techniques regarding expanding a frozen stock of cells so that the MTS assay for nanocytotoxicity can be performed [12] . If a stock culture of a cell line is stored, storage shall be at −80 °C or below in the corresponding culture medium but containing a cryoprotectant, e.g. dimethylsulfoxide or glycerol. Long-term storage (several months up to many years) is only possible at −130 °C or below. Only cells free from mycoplasma shall be used for the test. Before use, stock cultures should be tested for the absence of mycoplasma. NOTE 1 It is important to check cells regularly [e.g. morphology, doubling time, modal chromosome number, short tandom repeat (STR) testing] because sensitivity in tests can vary with passage number. NOTE 2 Nanoparticle can interact with cells through different mechanisms. It is useful to include both a phagocytic cell line (i.e. macrophage) and a non-phagocytic cell line (i.e. epithelial or fibroblast) in these studies. Assay results with the use of these two cell types can provide insight into the mode of action for nanoparticle toxicity.