Technical Specifications Series

The Technical Specifications Series (TSS) set out the performance evaluation criteria for meeting prequalification requirements. Each TSS document provides information on the minimum performance requirements for WHO prequalification that should be met by a manufacturer to ensure that the in vitro diagnostic that is being submitted for prequalification is safe and performs optimally. (A transition period is being applied for those products prequalified before the relevant TSS document was issued. Manufacturers must comply with the technical specifications in the relevant TSS document within three years of its publication.)

Compliance with prequalification technical specifications is verified during re-inspection. Failure to comply with the relevant technical specifications will result in the delisting of the product concerned from the WHO List of Prequalified IVDs.