Arthrex

10.5 mm Graft Harvesting Cutting Guide, Transtibial ACL Reconstruction Set

Reusable and Single Use Non Sterile Instruments Directions for Use

13 Pages

Instruments DFU-0023-EO Revision 1 2022-08 Important Product Information Symbols glossary can be found at www.arthrex.com/symbolsglossary. See package label for usability type and CE mark Reusable non-sterile instruments Single-use non-sterile instruments Reusable non-sterile/sterile instruments that may be attached to power No CE mark: For devices not sold to CE Accepting Countries A. REFERENCES These instructions were developed using the guidance given in the following standards (ANSI: American National Standards Institute; AAMI: Association for the Advancement of Medical Instrumentation; ST: Standard; TIR: Technical Information report; ISO: International Organization for Standardization; FDA: Food and Drug Administration): •  ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities  •  ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices  •  ISO 17665-1: Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices  •  AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices  •  AAMI ST77: Containment devices for reusable medical device sterilization  •  AAMI TIR 34: Water for the reprocessing of medical devices  DFU-0023-EOr1_fmt_en  Page 1 of 13
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