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By Michael Nevin Helmus

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3. continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials Standards/ Guidelines FDA Standards/ Guidelines ASTM, ANSI Standards/ Guidelines ISO Guidance Document Approval Requirements for IOLs with an Extended Power Range Electrode and insulation material; Engineering plastic housing or metallic alloy housing Soft and hard tissue compatibility; Chronic tissue irritation of soft tissue and adhacent nerves Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years; Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Adults at Least 18 years of age.

Medical Device and Diagnostic Industry, June 1998:58. 13 Detailed description of sterilization methodologies and medical device infections can be found in "Disinfection, Sterilization, and Preservation" Seymour Block, ed. Lippincott, Williams & Wilkins, 2000.

Continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials nonwoven polyester; Hermetic Package— Aluminum with polyolefin layer Tray—polycarbonate; polyester; polysulfone; acrylic; PVC; Permeable barrier—nonwoven polyester Radiation— Gamma; EBeam Tray— polycarbonate; polyester; polysulfone; Permeable barrier— nonwoven polyester; Hermetic Package— Aluminum with polyolefin layer Standards/ Guidelines ASTM, ANSI Standards/ Guidelines ISO Biomaterials in the Design and Reliability of Medical Devices ETO Sterilization Standards/ Guidelines FDA Overview and Introduction 53 Central venous catheters and vascular access ports: • Ease of infusing fluids through the device • Puncture resistance of port septums for the totally implantable vascular access ports • Textile/porous cuffs for tissue ingrowth and catheter stabilization • Antimicrobial cuffs to reduce infection • Easy repair of the externalized catheter portion for the externalized access catheters Angioplasty catheters: • Volume pressure relationships of balloon • Balloon inflation times • Balloon compliance (compliant vs.

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