CEN TS 16800 Guideline for Validation of Physico-Chemical Analytical Methods

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of CEN TS 16800 test. This standard describes an approach for the validation of physico-chemical analytical methods for environmental solid matrices and water.

The guidance in this standard deals with the initial description of the method and two different validation approaches, in order of increasing complexity. These:

• Method development if the method was developed by the laboratory, or if the method is a standard protocol adopted by the laboratory, the conditions for adoption;
• Single lab-level validation (in-lab validation);
• Method validation at several laboratory levels (inter-laboratory or inter-laboratory validation), focusing on methods that are mature and robust enough to be implemented by routine laboratories and not just by a few specialized laboratories.

The concept is strictly hierarchical, meaning that a method must meet all the criteria for in-laboratory validation before entering the interlaboratory validation protocol.

This standard applies to the validation of a wide variety of quantitative physico-chemical test methods for the analysis of solid environmental matrices such as water (including drinking water, surface water, groundwater, wastewater, seawater) and soil. It is designed for standard protocols adopted by a laboratory and test methods targeting substances of recent interest, or test methods applying recently developed technologies.

The minimum requirements indispensable for the characterization of the suitability of an analytical method for its intended purpose are: selectivity, precision, accuracy, performance characteristics, and measurement uncertainty. The purpose of validation is to prove that these requirements are met.

EUROLAB assists manufacturers with CEN TS 16800 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.