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U.S. Department of Health and Human Services

Recognized Consensus Standards

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01/14/2019 Ophthalmic 10-114 ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
12/21/2020 Ophthalmic 10-119 ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
09/17/2018 Ophthalmic 10-84 ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
09/17/2018 Ophthalmic 10-113 ANSI Z80.30-2018 American National Standard for Ophthalmics - Toric Intraocular Lenses
12/20/2021 Ophthalmic 10-129 ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
01/30/2014 Ophthalmic 10-88 ASTM D790-10 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
09/17/2018 Ophthalmic 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
09/17/2018 Ophthalmic 10-57 ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics - Phakic Intraocular Lenses
09/17/2018 Ophthalmic 10-111 ISO 11981 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
04/04/2016 Ophthalmic 10-100 ISO 18259 First Edition 2014-10-01 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
08/14/2015 Ophthalmic 10-98 ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015 Ophthalmic 10-97 ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
08/02/2011 Ophthalmic 10-65 ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
01/27/2015 Ophthalmic 10-91 ISO 11979-10 First edition 2006-08-15 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]
07/15/2019 Ophthalmic 10-116 ANSI Z80.35-2018 American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
09/17/2018 Ophthalmic 10-56 ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
06/07/2021 Ophthalmic 10-122 ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
08/14/2015 Ophthalmic 10-96 ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
01/14/2019 Ophthalmic 10-108 ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
06/07/2021 Ophthalmic 10-123 ISO 15004-1 Second edition 2020-5 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
08/02/2011 Ophthalmic 10-66 ISO 10936-2 Second edition 2010-01-15 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
06/07/2021 Ophthalmic 10-125 ISO 11979-7 Fourth edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
01/14/2019 Ophthalmic 10-93 ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
01/14/2019 Ophthalmic 10-74 ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
01/14/2019 Ophthalmic 10-85 ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
01/14/2019 Ophthalmic 10-86 ISO 14729 First edition 2001-04-15 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
08/21/2017 Ophthalmic 10-104 ANSI Z80.20-2016 (R2021) American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
07/15/2019 Ophthalmic 10-89 ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics - Intraocular Lenses
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
07/15/2019 Orthopedic 11-358 ISO 14242-4 First edition 2018-05 Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
07/15/2019 Orthopedic 11-356 ISO 15142-2 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
12/21/2020 Orthopedic 11-371 ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
12/21/2020 Orthopedic 11-372 ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
07/15/2019 Orthopedic 11-354 ASTM F3295 - 18 Standard Guide for Impingement Testing of Total Disc Prostheses
12/21/2020 Orthopedic 11-374 ISO 7207-2 Second edition 2011-07-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
01/14/2019 Orthopedic 11-348 ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
01/14/2019 Orthopedic 11-184 ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
12/21/2020 Orthopedic 11-330 ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
09/17/2018 Orthopedic 11-336 ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
09/17/2018 Orthopedic 11-338 ISO 11491 First edition 2017-07 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
09/17/2018 Orthopedic 11-341 ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
08/06/2013 Orthopedic 11-254 ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
12/23/2016 Orthopedic 11-312 ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
12/23/2016 Orthopedic 11-314 ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
01/14/2019 Orthopedic 11-272 ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
01/14/2019 Orthopedic 11-344 ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
08/14/2015 Orthopedic 11-266 ASTM F2665-09 (Reapproved 2014) Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-387 ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
06/27/2016 Orthopedic 11-305 ASTM F1781-15 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/20/2021 Orthopedic 11-389 ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
09/17/2018 Orthopedic 11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
09/17/2018 Orthopedic 11-199 ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
09/17/2018 Orthopedic 11-326 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-329 ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
09/17/2018 Orthopedic 11-197 ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-327 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
09/17/2018 Orthopedic 11-340 ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
09/17/2018 Orthopedic 11-324 ASTM F366-17 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
08/21/2017 Orthopedic 11-269 ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
04/04/2016 Orthopedic 11-299 ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
04/04/2016 Orthopedic 11-303 ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
12/20/2021 Orthopedic 11-386 ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-393 ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/20/2021 Orthopedic 11-390 ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
01/30/2014 Orthopedic 11-239 ASTM F2345-03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
07/15/2019 Orthopedic 11-352 ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
01/14/2019 Orthopedic 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
12/20/2021 Orthopedic 11-388 ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
01/14/2019 Orthopedic 11-345 ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
01/30/2014 Orthopedic 11-264 ASTM F1820-13 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
08/21/2017 Orthopedic 11-175 ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
08/21/2017 Orthopedic 11-309 ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
01/30/2014 Orthopedic 11-232 ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
01/30/2014 Orthopedic 11-274 ISO 18192-2 First edition 2010-06-15 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
12/20/2021 Orthopedic 11-392 ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
01/30/2014 Orthopedic 11-75 ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
12/20/2021 Orthopedic 11-391 ASTM F2722 - 21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
01/30/2014 Orthopedic 11-74 ISO 5838-2 First edition 1991-01-15 Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
07/09/2014 Orthopedic 11-276 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 Orthopedic 11-277 ISO 7206-6 Second edition 2013-11-15 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
07/15/2019 Orthopedic 11-359 ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
09/17/2018 Orthopedic 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
07/06/2020 Orthopedic 11-363 ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
08/21/2017 Orthopedic 11-280 ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
08/21/2017 Orthopedic 11-321 ASTM F2887-17 Standard Specification for Total Elbow Prostheses
01/27/2015 Orthopedic 11-283 ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
08/06/2013 Orthopedic 11-252 ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
12/23/2016 Orthopedic 11-311 ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
01/30/2014 Orthopedic 11-83 ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
07/15/2019 Orthopedic 11-353 ISO 18192-3 First edition 2017-06 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
04/04/2016 Orthopedic 11-247 ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
08/14/2015 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
06/27/2016 Orthopedic 11-308 ASTM F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
06/07/2021 Orthopedic 11-379 ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
01/14/2019 Orthopedic 11-343 ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
08/21/2017 Orthopedic 11-242 ASTM F1839-08 (Reapproved 2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
 
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