ISO TS 19337:2016 pdf free

ISO TS 19337:2016 pdf free.Nanotechnologies一Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity
Metal ions, produced as a result of nano-object test sample dissolution, can contribute to test cell toxicity. The concentration of metal ions in the working suspension shall be measured after separation of particulate matter. Particulate matter can be separated from the ionic fraction by ultra-filtration (U/F)，ultra filtration assisted by centrifugation (C-U/F) or tangential flow filtration (TFF). The measurement shall be made for all metallic elements that are included in the nano-object sample. An appropriate method shall be selected to measure the metal ion concentrations from among inductively coupled plasma-atomic emission spectrometry (ICP-AES), ICP-MS, atomic absorption spectrometry (AAS) and the colourimetric method. Other methods deviating from this Technical Specification can be used and reported in accordance with 6.6. Measurement results of concentrations shall be expressed in the unit of molarity, mass/mass or mass/volume. The measurements can be omitted when a toxic effect is not observed to the cells in the working suspensions. See Annex A for an example of flow of measurements.
A nano-object sample added to a culture medium to generate a working suspension may adsorb components of the culture medium.1] This can result in starvation stress to the test cells. The concentration of protein components and calcium, as surrogates for the nutritional components in the solvent shall be measured by setting aside enough time after the addition of nano-object sample to the culture medium. If culture medium components other than protein and calcium that may significantly affect the stability of working suspension for in vitro toxicity assays are known, the concentration of those components shall be measured as well. The measurements can be omitted when a toxic effect is not observed to the cells in the working suspensions. See Annex A for an example of flow of measurements.ISO TS 19337 pdf free download.