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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2016 Orthopedic 11-311 Complete 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 11-74 Complete 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 Complete ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
12/18/2023 Orthopedic 11-404 Complete ASTM F2887-23 Standard Specification for Total Elbow Prostheses
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
09/17/2018 Orthopedic 11-335 Complete ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
12/18/2023 Orthopedic 11-407 Complete ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
09/17/2018 Orthopedic 11-341 Complete ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
09/11/2023 Orthopedic 11-400 Complete ISO 21536 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
09/11/2023 Orthopedic 11-401 Complete ISO 21535 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
04/04/2016 Orthopedic 11-303 Complete ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
12/18/2023 Orthopedic 11-405 Complete ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
12/18/2023 Orthopedic 11-403 Complete ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
06/07/2021 Orthopedic 11-377 Complete ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
12/18/2023 Orthopedic 11-402 Complete ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
09/17/2018 Orthopedic 11-334 Complete ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
04/04/2016 Orthopedic 11-301 Complete ASTM F2091-15 Standard Specification for Acetabular Prostheses
07/15/2019 Orthopedic 11-352 Complete 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)]
12/18/2023 Orthopedic 11-406 Complete ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
05/29/2023 Orthopedic 11-399 Complete ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
08/14/2015 Orthopedic 11-294 Complete ASTM F1357-14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
08/21/2017 Orthopedic 11-175 Complete ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
01/30/2014 Orthopedic 11-75 Complete ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
09/17/2018 Orthopedic 11-326 Complete ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-327 Complete ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
08/06/2013 Orthopedic 11-254 Complete ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
12/20/2021 Orthopedic 11-393 Complete ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
08/21/2017 Orthopedic 11-309 Complete ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
01/30/2014 Orthopedic 11-232 Complete 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
09/17/2018 Orthopedic 11-336 Complete 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 Complete 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 11-333 Complete ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
12/23/2016 Orthopedic 11-319 Complete ISO 7206-12 First edition 2016-10-01 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
08/21/2017 Orthopedic 11-242 Complete ASTM F1839-08 (Reapproved 2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
12/20/2021 Orthopedic 11-385 Complete ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
12/20/2021 Orthopedic 11-386 Complete ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
09/17/2018 Orthopedic 11-310 Complete ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
07/06/2020 Orthopedic 11-367 Complete ISO 14243-3 Second edition 2014-11-01 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020 Orthopedic 11-368 Complete ASTM F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
08/21/2017 Orthopedic 11-280 Complete ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
12/23/2016 Orthopedic 11-312 Complete 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 Complete ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
07/06/2020 Orthopedic 11-365 Complete ASTM F1800-19 e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
09/17/2018 Orthopedic 11-324 Complete ASTM F366-17 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
01/27/2015 Orthopedic 11-281 Complete ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
07/09/2014 Orthopedic 11-277 Complete 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
04/04/2016 Orthopedic 11-299 Complete ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
01/27/2015 Orthopedic 11-283 Complete ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
01/14/2019 Orthopedic 11-347 Complete ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
06/27/2016 Orthopedic 11-308 Complete ASTM F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
08/14/2015 Orthopedic 11-290 Complete ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/23/2016 Orthopedic 11-317 Complete ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
12/23/2019 Orthopedic 11-361 Complete ISO 14243-5 First edition 2019-05 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
01/14/2019 Orthopedic 11-272 Complete ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
01/14/2019 Orthopedic 11-344 Complete ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
06/27/2016 Orthopedic 11-307 Complete ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
08/21/2017 Orthopedic 11-269 Complete ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
12/20/2021 Orthopedic 11-390 Complete 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
09/17/2018 Orthopedic 11-185 Complete 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 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-199 Complete ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
12/19/2022 Orthopedic 11-395 Complete ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
12/19/2022 Orthopedic 11-396 Complete ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
04/04/2016 Orthopedic 11-304 Complete ASTM F3107-14 (Reapproved 2023) Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
12/21/2020 Orthopedic 11-370 Complete ISO 14879-1 Second edition 2020-07 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
12/21/2020 Orthopedic 11-373 Complete ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
01/30/2014 Orthopedic 11-274 Complete ISO 18192-2 First edition 2010-06-15 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
07/15/2019 Orthopedic 11-355 Complete ISO 15142-1 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
07/15/2019 Orthopedic 11-357 Complete ISO 15142-3 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
12/18/2023 Orthopedic 11-408 Complete ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
12/23/2019 Orthopedic 11-362 Complete ISO 22622 First edition 2019-07 Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
09/17/2018 Orthopedic 11-329 Complete ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
01/14/2019 Ophthalmic 10-114 Complete ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 Complete ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
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
06/07/2021 Ophthalmic 10-124 Complete ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
04/04/2016 Ophthalmic 10-100 Complete 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
06/07/2021 Ophthalmic 10-126 Complete IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
ANSI AAMI IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
08/14/2015 Ophthalmic 10-98 Complete 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 Complete ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
09/17/2018 Ophthalmic 10-84 Complete ANSI Z80.11-2012 (R2022) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
09/17/2018 Ophthalmic 10-113 Complete ANSI Z80.30-2018 (R2023) American National Standard for Ophthalmics - Toric Intraocular Lenses
08/14/2015 Ophthalmic 10-99 Complete ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
08/21/2017 Ophthalmic 10-103 Complete ANSI Z80.18-2016 (R2021) American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
12/19/2007 Ophthalmic 10-39 Complete ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
03/16/2012 Ophthalmic 10-70 Complete ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
08/14/2015 Ophthalmic 10-94 Complete ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/14/2015 Ophthalmic 10-95 Complete ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
06/07/2018 Ophthalmic 10-105 Complete ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
06/07/2018 Ophthalmic 10-106 Complete ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-107 Complete ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
09/21/2016 Ophthalmic 10-101 Complete ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
05/29/2024 Ophthalmic 10-136 Complete IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
06/07/2018 Ophthalmic 10-109 Complete ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
 
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