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Normas DIN – AENOR
DIN CEN/TS 16800:2016-03;DIN SPEC 38402-61:2016-03

DIN CEN/TS 16800:2016-03;DIN SPEC 38402-61:2016-03

Guideline for the validation of physico-chemical analytical methods (CEN/TS 16800:2015); German version CEN/TS 16800:2015

Lignes directrices pour la validation des méthodes d'analyse physico-chimiques (CEN/TS 16800:2015); Version allemande CEN/TS 16800:2015

Anleitung zur Validierung von physikalisch-chemischen Analysenverfahren (CEN/TS 16800:2015); Deutsche Fassung CEN/TS 16800:2015

Fecha:
2016-03 /Active
Equivalencias internacionales:

CEN/TS 16800 (2015-12)

Resumen:
This Technical Specification describes an approach for the validation of physico-chemical analytical methods for environmental matrices.The guidance in this document addresses two different validation approaches, in increasing order of complexity. These are: a) method development and validation at the level of single laboratories (intra-laboratory validation); b) method validation at the level of several laboratories (between-laboratory or inter-laboratory validation), with a focus on methods that are sufficiently mature and robust to be applied not only by a few expert laboratories but by laboratories operating at the routine level. The concept of these two approaches is strictly hierarchical, i.e. a method shall fulfil all criteria of the first level before it can enter the validation protocol of the second level. This Technical Specification is applicable to the validation of a broad range of quantitative physico-chemical analytical methods for the analysis of water (including surface water, groundwater, waste water, and sediment). Analytical methods for other environmental matrices, like soil, sludge, waste, and biota can be validated in the same way. It is intended either for analytical methods aiming at substances that have recently become of interest or for test methods applying recently developed technologies. The minimal requirements that are indispensable for the characterization of the fitness for purpose of an analytical method are: selectivity, precision, bias and measurement uncertainty. The aim of validation is to prove that these requirements are met.
Keywords:
Analytical methods, Chemical analysis and testing, Chemical substances, Chemical water pollutants, Chemistry of water, Definitions, Environment, Ground water, Instructions, Investigation methods, Laboratory tests, Matrices, Methods, Methods of analysis, Physical chemistry, Physico-chemical methods, Pollution control, Quantitative analysis, Sediment, Sewage, Surface water, Validation, Verification, Water analysis, Water practice, Water samples, Water testing
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