CEN/TS 16800-2015
物理化学分析方法验证指南

Guideline for the validation of physico-chemical analytical methods


CEN/TS 16800-2015 发布历史

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.

CEN/TS 16800-2015由欧洲标准化委员会 IX-CEN 发布于 2015-12。

CEN/TS 16800-2015 在中国标准分类中归属于: A84 包装工具,在国际标准分类中归属于: 13.060.50 水的化学物质检验。

CEN/TS 16800-2015 发布之时,引用了标准

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标准号
CEN/TS 16800-2015
发布日期
2015年12月
实施日期
废止日期
中国标准分类号
A84
国际标准分类号
13.060.50
发布单位
IX-CEN
引用标准
EN ISO 9000-2015 EN ISO/IEC 17025-2005 EN ISO/IEC 17043-2010 NF T90-210-2009 ISO Guide 30-2015 ISO/IEC Guide 98-3-2008 ISO/IEC Guide 99-2007 ISO 78-2-1999 ISO 690-2010 ISO 3534-1-2006
被代替标准
FprCEN/TS 16800-2014
适用范围
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.




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