English to Polish Other Environment & Ecology general

Tekst o badaniach mikrobiologicznych wody, o wprowadzaniu nowych metod.

The first process in the introduction of a new method is the generation of performance characterisation data by the developer or manufacturer of the method using the procedures and criteria of ISO 13843:2017. The previous edition of this standard (ISO/TR 13843:2000) referred to the process as “validation”. This is an incorrect use of the term as validation is a separate process involving co-ordinated multi-laboratory comparison and performance studies (e.g., according to ISO 16140-2:2016). The misuse of the term “validation” in this context has led to confusion with respect to what is required in the process of adopting a new method.
The principle aim of the performance characterisation process is to provide data on the following key aspects of a methods performance:
Sensitivity
Specificity
False-positive rate
False-negative rate
Selectivity
Efficiency