PD CEN/TS 16800:2015 - Guideline for the validation of physico-chemical analytical methods

PD CEN/TS 16800:2015

Guideline for the validation of physico-chemical analytical methods

Status : Current, Under review   Published : December 2015



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:

  1. method development and validation at the level of single laboratories (intra-laboratory validation);

  2. 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 physicochemical 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.

Standard NumberPD CEN/TS 16800:2015
TitleGuideline for the validation of physico-chemical analytical methods
StatusCurrent, Under review
Publication Date31 December 2015
Normative References(Required to achieve compliance to this standard)ISO/IEC Guide 99:2007, ISO 5725, ISO 21748:2010, ISO 11352:2012, ISO 78-2
Informative References(Provided for Information)ISO/IEC 17025:2005, ISO 3534-2:2006, ISO 11843, NF T90-210, NEN 7777, ISO 8466-1:1990, EN ISO 9000:2015, ISO 8466-2:2001, ISO 9000:2015, ISO 5725-3, ISO 3534-1, ISO Guide 30:2015, ISO/TS 20612:2007, EN ISO/IEC 17043:2010, ISO/TS 13530:2009, ISO/IEC 17043:2010, EN ISO/IEC 17025, ISO 5725-1:1994, ISO 13528:2015, ISO 5725-5:1998, ISO/IEC Guide 98-3, ISO 5725-4:1994, ISO 5725-2, ISO 690
International RelationshipsCEN/TS 16800:2015
DescriptorsReports, Test equipment, Standardization, Test specimens, Chemical reagents, Reproducibility, Units of measurement, Technical writing, Terminology, Symbols, Laboratory equipment, Data layout, Quality assurance, Standards, Layout, Quality control, Chemical analysis and testing, Precision, Selection, Sampling methods, Chemistry, Statistical methods of analysis
Title in FrenchLignes directrices pour la validation des méthodes d'analyse physico-chimiques
Title in GermanAnleitung zur Validierung physikalisch-chemischer Analysenverfahren
ISBN978 0 580 87777 3
File Size688 KB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


The faster, easier way to work with standards

Worldwide Standards
We can source any standard from anywhere in the world

Develop a PAS

Develop a fast-track standardization document in 9-12 months