Guideline for the validation of physico-chemical analytical methods
Guideline for the validation of physico-chemical analytical methods
Мы хотим включить аналитику посещений, чтобы понимать, что искать людям на сайте. Без вашего согласия счётчики не загружаются. Политика конфиденциальности
1 Scope 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 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 fo...
Другие стандарты PD
1 Scope This document specifies a reference architecture for event-based syndromic surveillance systems for infectious diseases. The system reference architecture addresses architectural components i…
1 Scope This document provides guidance on the characterization of wood chips produced from raw materials, as defined in ISO 17225‑4 , for the following aspects: quality classes and specifications; s…
1 Scope This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, ut…
1 Scope This document specifies the interface architecture of industrial digital twin systems, which is structured around three key elements: the digital twin, the physical twin and the interface tha…