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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/06/2013 Materials 8-158 Complete ASTM F1713-08 (Reapproved 2013) Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)
08/06/2013 ObGyn/
Gastroenterology/
Urology		 9-31 Complete ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
08/06/2013 Ophthalmic 10-77 Complete ISO 9394 Third edition 2012-10-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
08/06/2013 Ophthalmic 10-78 Complete ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
08/06/2013 Orthopedic 11-252 Complete ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
08/06/2013 Orthopedic 11-254 Complete ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
08/06/2013 Physical Medicine 16-190 Complete ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
08/06/2013 Physical Medicine 16-192 Complete ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
08/06/2013 Radiology 12-211 Complete IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
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