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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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Title of Standard
 
 
12/21/2020 Materials 8-554 ASTM ISO TR 52912 First edition 2020-09 Additive manufacturing - Design - Functionally graded additive manufacturing
12/21/2020 Nanotechnology 18-17 ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
12/21/2020 Neurology 17-17 ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
12/21/2020 ObGyn/
Gastroenterology/
Urology
9-130 ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
12/21/2020 Ophthalmic 10-119 ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
12/21/2020 Ophthalmic 10-120 ISO TR 22979 Second Edition 2017-05 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
12/21/2020 Ophthalmic 10-121 ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
12/21/2020 Orthopedic 11-330 ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
12/21/2020 Orthopedic 11-370 ISO 14879-1 Second edition 2020-07 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
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