BS PD CEN/TS 16800:2015 describes an approach for the validation of physico-chemical analyticalmethods for environmental matrices.The guidance in this document addresses two different validation approaches, in increasing order ofcomplexity. These are:
- method development and validation at the level of single laboratories (intra-laboratory validation);
- method validation at the level of several laboratories (between-laboratory or inter-laboratoryvalidation), with a focus on methods that are sufficiently mature and robust to be applied not onlyby 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 thefirst 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 physicochemicalanalytical methods for the analysis of water (including surface water, groundwater, wastewater, and sediment). Analytical methods for other environmental matrices, like soil, sludge, waste, andbiota can be validated in the same way. It is intended either for analytical methods aiming at substancesthat 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 ofan analytical method are: selectivity, precision, bias and measurement uncertainty. The aim ofvalidation is to prove that these requirements are met.
Cross References:ISO 78-2ISO 5725ISO 11352:2012ISO 21748:2010ISO/IEC Guide 99:2007ISO 690ISO 3534-1ISO 3534-2:2006ISO 5725-1:1994ISO 5725-2ISO 5725-3ISO 5725-4:1994ISO 5725-5:1998ISO 8466-1:1990ISO 8466-2:2001ISO 11843ISO 13528:2015ISO/TS 20612:2007ISO/TS 13530:2009EN ISO/IEC 17025ISO/IEC 17025:2005EN ISO/IEC 17043:2010ISO/IEC 17043:2010EN ISO 9000:2015ISO 9000:2015ISO Guide 30:2015ISO/IEC Guide 98-3NEN 7777NF T90-210
