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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/09/2014 Orthopedic 11-276 Complete ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
01/27/2015 Dental/
ENT		 4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
01/27/2015 Dental/
ENT		 4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
01/27/2015 Materials 8-171 Complete ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/27/2015 Materials 8-383 Complete ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 Complete ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
01/27/2015 Orthopedic 11-281 Complete ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
01/27/2015 Software/
Informatics		 13-72 Complete IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
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