ISO 11138 Accredited Testing Labs in United States
ISO 11138, all parts: Sterilization of health care products - Biological indicators2 laboratories in United States are accredited by A2LA for at least one part of ISO 11138. Each lab card shows which parts it holds. From the accredited scope text: “ISO 11138-1 Chemical Indicators – Compliance Testing (Dry Heat, Steam) ANSI/AAMI/ISO 11140-1 Material Compatibility/Reusability of Medical Devices AAMI TIR 17 Sterilization Packaging Systems – Acceler” “ISO 11138-1: General Requirements and Annex D Chemical Indicators – Compliance Testing ANSI/AAMI/ISO 11140-1 Materials Compatibility AAMI TIR 12; AAMI TIR 17 Sterilization Validation ANSI/AAMI/ISO 117”
This page is a fixed slice of the register: every ISO 11138 scope we hold for United States. Search narrows it further by city, accreditation body, or a term from the scope text itself.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.