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  1. CDRH Offices

Standards and Guidance Documents for Infection Control

Guidances

  • FDA/CDRH guidance on Premarket notification of 510(k) for contact lens care products, 1997
  • CDRH Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]
  • CDRH Guidance for Industry and FDA Staff: Reusable medical devices: Labeling reusable medical devices for reprocessing in health care facilities. 

Standards

  • ISO 14729 Ophthalmic Optics- Contact lens care products-Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
  • ANSI Z80.18-2003: Contact lens care products
  • AAMI TIR 12: Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: a guide for device manufacturers.
  • AAMI TIR 30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
  • AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.