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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
05/29/2024 Materials 8-615 Complete ISO ASTM 52926-1 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators
05/29/2024 Materials 8-616 Complete ISO ASTM 52926-2 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB
05/29/2024 Materials 8-617 Complete ISO ASTM 52926-3 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB
05/29/2024 Neurology 17-18 Complete IEEE Std 2010-2023 Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems
05/29/2024 Neurology 17-19 Partial ISO 80601-2-85 Edition 1.0 2021-03 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
05/29/2024 Ophthalmic 10-134 Partial ISO 10943 Fourth edition 2023-01 Ophthalmic instruments - Indirect ophthalmoscopes
05/29/2024 Ophthalmic 10-135 Partial ISO 11979-7 Fifth edition 2024-01 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
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