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Regulatory Information
Guidelines & Standards
References		 ISO • EN • FDA
ISO 13485 Certification
Guidelines & Standards
  1. ISO 13485: 2003, Medical Devices - Quality Managment Systems - Requirements for Regulatory Purposes.
  2. AAMI/ANSI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.
  3. AAMI/ANSI/ISO 11137-2:2006, Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose.
  4. AAMI/ANSI/ISO 11137-3:2006, Sterilization of healthcare products - Radiation - Part 3: Guidance on dosimetric aspects.
  5. AAMI/ANSI/ISO 11737-1:1995, Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products.
  6. ANSI/AAMI /ISO 11737-2:1998, Sterilization of medical devices - Microbiological methods - Part 2:Tests of sterility performed in the validation of a sterilization process.
  7. AAMI TIR No. 17 - 1997, Radiation Sterilization - Material qualification.
  8. AAMI TIR33:2005, Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose – Method VDmax
  9. BS EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation.