SRI Surgical FDA Compliance - 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.
         
 

FDA Compliance

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.
  
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