What standards does WHO apply for prequalification of immunization devices?

All areas of WHO prequalification of immunization devices are governed by standard operating procedures that are informed by key external standards and processes:

• performance specifications and product verification procedures are informed by ISO and other standards
• laboratory accreditation procedures stipulate the need for laboratories to be ISO/IEC 17025-accreditated by International Laboratory Accreditation Cooperation signatories or other accreditation bodies
• product field-testing procedures are guided by industry-standard and WHO protocols.