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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 General Plastic Surgery/
General Hospital		 6-498 Complete ISO 10555-4 Third edition 2023-11 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
05/29/2024 General Plastic Surgery/
General Hospital		 6-499 Complete ISO 10555-1 Third edition 2023-11 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
05/29/2024 General Plastic Surgery/
General Hospital		 6-500 Complete IEC 63045 Edition 1.0 2020-05 Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
05/29/2024 General Plastic Surgery/
General Hospital		 6-501 Complete ISO 15747 Third edition 2018-09 Plastic containers for intravenous injections
05/29/2024 General Plastic Surgery/
General Hospital		 6-502 Complete ISO 23217 First Edition 2024-02 Injection systems for self-administration by paediatric patients - Requirements and guidelines for design
05/29/2024 InVitro Diagnostics 7-321 Partial CLSI MM24 1st Edition Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
05/29/2024 Materials 8-611 Complete ISO 9584 Second edition 2023-10 Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants
05/29/2024 Materials 8-612 Complete ASTM F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments
05/29/2024 Materials 8-613 Complete ASTM F2527-24 Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants
05/29/2024 Materials 8-614 Complete ASTM F3456-22 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials
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