ISO/TS 16099:2025

This document specifies the minimum technical requirements and performance characteristics for the detection of molecular nucleic acid (DNA or RNA) sequences of specific microorganisms present in water using molecular detection methods based on polymerase chain reaction (PCR). This includes guidelines for validation of PCR related methods (inclusivity, exclusivity, specificity, limits of detection and quantification, linearity, robustness, recovery, and calibration). This document describes also topics related to quality control which are in general related to the use of PCR related methods, including on-site PCR systems and methods. This document is applicable to all kinds of water including potable, industrial, waste, and natural waters.