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Standards Development
This Technical Specification is intended to support users of reference materials (RMs) for particle size analysis to identify suitable RMs for their needs. In line with the focus on RM users, questions on sample preparation that go beyond preparation of the RM sample as received by the user will not be covered by this Technical Specification.
This Technical Specification describes the fundamental requirements that reference materials for the determination of particle size shall fulfil to be fit for a given purpose. The document is limited to a description of the fundamental principles - the discussion whether a certain numerical value is fit for purpose is beyond the scope of this document.
The scope of this technical specification is limited to reference materials in the form of particles. It does not deal with any other form of reference materials, like calibration grids.
Reference materials are crucial in several steps of the determination of particle characterisation: calibration of instruments, demonstration that instruments are operated as described in the respective standards and routine quality control.
Particle size measurements are special inasmuch as many methods report a “particle diameter”. These are, however, equivalent diameters and not necessarily comparable between methods. This has implications for the selection of reference materials for particle size measurements as choosing a reference material with a value incompatible to the method in question will not be suitable for calibration and quality control.
This TS specifies the requirements reference materials must fulfil to be suitable for the method to be calibrated/controlled. Discussions in ISO/TC24/SC4 and with reference material users confirm that there is a lack of clarity which kind of reference material can be used for which purpose. For example, reference materials certified for sedimentation analysis are used to calibrate unrelated methods, which introduces a measurement bias. This TS will clarify the underlying concepts for reference material selection and will clearly specify the requirements reference materials need to fulfil if they are used for installation qualification, calibration, operation qualification or statistical quality control. It will therefore ensure that suitable reference materials are chosen and hence contribute to the reliability of the other measurement methods.
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