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U.S. Department of Health and Human Services

Recognized Consensus Standards
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12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-143 ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-144 ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use
12/19/2007 Ophthalmic 10-37 ISO 10942 Second edition 2006-06-01 Ophthalmic instruments - Direct ophthalmoscopes
12/19/2007 Ophthalmic 10-39 ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
09/17/2018 Ophthalmic 10-56 ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
09/17/2018 Ophthalmic 10-57 ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics - Phakic Intraocular Lenses
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
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
03/16/2012 Ophthalmic 10-70 ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
01/14/2019 Ophthalmic 10-74 ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
08/06/2013 Ophthalmic 10-77 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 ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
09/17/2018 Ophthalmic 10-84 ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
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]
07/15/2019 Ophthalmic 10-89 ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics - Intraocular Lenses
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)]
01/14/2019 Ophthalmic 10-93 ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
08/14/2015 Ophthalmic 10-94 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 ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
08/14/2015 Ophthalmic 10-96 ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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
08/14/2015 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 10-99 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
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
09/21/2016 Ophthalmic 10-101 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
08/21/2017 Ophthalmic 10-103 ANSI Z80.18-2016 (R2021) American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
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
06/07/2018 Ophthalmic 10-105 ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
06/07/2018 Ophthalmic 10-106 ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-107 ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
01/14/2019 Ophthalmic 10-108 ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
06/07/2018 Ophthalmic 10-109 ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
06/07/2018 Ophthalmic 10-110 ISO 15798 Third edition 2013-09-15 Ophthalmic implants - Ophthalmic viscosurgical devices [Including: Amendment 1 (2017)]
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
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 10-113 ANSI Z80.30-2018 American National Standard for Ophthalmics - Toric Intraocular Lenses
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
07/15/2019 Ophthalmic 10-116 ANSI Z80.35-2018 American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
07/15/2019 Ophthalmic 10-117 ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
07/15/2019 Ophthalmic 10-118 ANSI Z80.38-2017 (R2021) American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
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
06/07/2021 Ophthalmic 10-122 ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
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
06/07/2021 Ophthalmic 10-124 ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
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
06/07/2021 Ophthalmic 10-126 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)]
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)]
12/20/2021 Ophthalmic 10-127 ANSI Z80.21-2020 American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
12/20/2021 Ophthalmic 10-128 ASTM D882-18 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
12/20/2021 Ophthalmic 10-129 ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
12/20/2021 Ophthalmic 10-130 ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
05/30/2022 Ophthalmic 10-131 ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
12/19/2022 Ophthalmic 10-132 ISO 10942 Third edition 2022-01 Ophthalmic instruments - Direct ophthalmoscopes
12/19/2022 Ophthalmic 10-133 ISO 11979-10 Second edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
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
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
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
08/21/2017 Orthopedic 11-175 ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
08/14/2015 Orthopedic 11-183 ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
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
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 11-197 ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-199 ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
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
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
04/04/2016 Orthopedic 11-247 ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
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
08/06/2013 Orthopedic 11-254 ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
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 11-269 ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
01/14/2019 Orthopedic 11-272 ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
01/30/2014 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
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
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
01/27/2015 Orthopedic 11-281 ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
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
08/14/2015 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
08/14/2015 Orthopedic 11-294 ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
04/04/2016 Orthopedic 11-299 ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
04/04/2016 Orthopedic 11-301 ASTM F2091-15 Standard Specification for Acetabular Prostheses
04/04/2016 Orthopedic 11-303 ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
04/04/2016 Orthopedic 11-304 ASTM F3107-14 Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
06/27/2016 Orthopedic 11-307 ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
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
08/21/2017 Orthopedic 11-309 ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
09/17/2018 Orthopedic 11-310 ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
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
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
12/23/2016 Orthopedic 11-316 ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/23/2016 Orthopedic 11-317 ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
12/23/2016 Orthopedic 11-319 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
12/23/2016 Orthopedic 11-320 ISO 7206-13 First edition 2016-07-01 Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
08/21/2017 Orthopedic 11-321 ASTM F2887-17 Standard Specification for Total Elbow Prostheses
09/17/2018 Orthopedic 11-322 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
 
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