Description

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 78-2
ISO 5725
ISO 11352:2012
ISO 21748:2010
ISO/IEC Guide 99:2007
ISO 690
ISO 3534-1
ISO 3534-2:2006
ISO 5725-1:1994
ISO 5725-2
ISO 5725-3
ISO 5725-4:1994
ISO 5725-5:1998
ISO 8466-1:1990
ISO 8466-2:2001
ISO 11843
ISO 13528:2015
ISO/TS 20612:2007
ISO/TS 13530:2009
EN ISO/IEC 17025
ISO/IEC 17025:2005
EN ISO/IEC 17043:2010
ISO/IEC 17043:2010
EN ISO 9000:2015
ISO 9000:2015
ISO Guide 30:2015
ISO/IEC Guide 98-3
NEN 7777
NF T90-210