All equipment and procedures at our 10 processing facilities are FDA-regulated, requiring rigorous inspection processes to ensure that federally recommended guidelines are followed. These controls offer our customers the highest degree of quality assurance and service consistency.
- Instrument & Stainless processing meets standards in AAMI TIR 12 and ANSI/AAMI ST35.
- Sterilization process meets or exceeds ANSI/AAMI/ISO 17665, AAMI TIR No. 13, AAMI ISO 11737-2, ISO 13683 and AAMI ST46.
- All regulated processes are designed to comply FDA Quality Systems requirements 21 CFR Part 820.
- All reusable barrier products are processed per ANSI/AAMI ST65.
- Liquid proof barrier gown (PPE) products meet or exceed requirements in AAMI PB70.
- Liquid proof barrier drape products meet or exceed requirements in AAMI PB70.
- SRI Service Centers are FDA registered and are subject to regular inspections.