|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
09/17/2018 |
Ophthalmic |
10-57 |
Complete |
ANSI |
Z80.13-2007 (R2022) |
American National Standard for Ophthalmics - Phakic Intraocular Lenses |
09/17/2018 |
Ophthalmic |
10-111 |
Complete |
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 |
12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
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 |
06/07/2018 |
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 |
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 |
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 |
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 |
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 |
03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
12/20/2021 |
Ophthalmic |
10-129 |
Complete |
ASTM |
D790-17 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
12/19/2022 |
Ophthalmic |
10-133 |
Complete |
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. |
12/20/2021 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
05/30/2022 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
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 |
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 |
12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
08/02/2011 |
Ophthalmic |
10-66 |
Complete |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
09/17/2018 |
Ophthalmic |
10-56 |
Partial |
ANSI |
Z80.12-2007 (R2022) |
American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
06/07/2021 |
Ophthalmic |
10-123 |
Partial |
ISO |
15004-1 Second edition 2020-5 |
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
07/15/2019 |
Ophthalmic |
10-116 |
Partial |
ANSI |
Z80.35-2018 (R2023) |
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
06/07/2021 |
Ophthalmic |
10-122 |
Partial |
ISO |
10939 Third edition 2017-05 |
Ophthalmic instruments - Slit-lamp microscopes |
06/07/2021 |
Ophthalmic |
10-125 |
Partial |
ISO |
11979-7 Fourth edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
12/19/2022 |
Ophthalmic |
10-132 |
Partial |
ISO |
10942 Third edition 2022-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
08/06/2013 |
Ophthalmic |
10-77 |
Complete |
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 |
12/21/2020 |
Ophthalmic |
10-121 |
Complete |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
01/14/2019 |
Ophthalmic |
10-74 |
Partial |
ISO |
10940 Second edition 2009-08-01 |
Ophthalmic instruments - Fundus cameras |
01/14/2019 |
Ophthalmic |
10-85 |
Partial |
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 |
Partial |
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] |
06/07/2021 |
Ophthalmic |
10-124 |
Complete |
ISO |
11979-1 Fourth edition 2018-11 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
07/15/2019 |
Ophthalmic |
10-89 |
Partial |
ANSI |
Z80.7-2013 (R2023) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
08/21/2017 |
Ophthalmic |
10-104 |
Partial |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
01/14/2019 |
Ophthalmic |
10-93 |
Partial |
ANSI |
Z80.27-2014 (R2019) |
American National Standard for Ophthalmics - Implantable Glaucoma Devices |
01/14/2019 |
Ophthalmic |
10-108 |
Partial |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
08/14/2015 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
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 |
09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
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 |
12/20/2021 |
Orthopedic |
11-387 |
Complete |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
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 |
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 |
08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
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 |
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 |
08/14/2015 |
Orthopedic |
11-294 |
Complete |
ASTM |
F1357-14 (Reapproved 2019) |
Standard Specification for Articulating Total Wrist Implants |
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 |
12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
12/20/2021 |
Orthopedic |
11-393 |
Complete |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
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 |
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 |
05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
06/07/2021 |
Orthopedic |
11-381 |
Complete |
ASTM |
F2582-20 |
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
12/19/2022 |
Orthopedic |
11-395 |
Complete |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
07/15/2019 |
Orthopedic |
11-356 |
Complete |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
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)] |
12/20/2021 |
Orthopedic |
11-389 |
Complete |
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)] |
07/15/2019 |
Orthopedic |
11-354 |
Complete |
ASTM |
F3295-18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
12/21/2020 |
Orthopedic |
11-374 |
Complete |
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)] |
04/04/2016 |
Orthopedic |
11-301 |
Complete |
ASTM |
F2091-15 |
Standard Specification for Acetabular Prostheses |
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 |
12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
08/21/2017 |
Orthopedic |
11-309 |
Complete |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
08/21/2017 |
Orthopedic |
11-175 |
Complete |
ASTM |
F1582-98 (Reapproved 2016) |
Standard Terminology Relating to Spinal Implants |
12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
08/06/2013 |
Orthopedic |
11-252 |
Complete |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
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 |
11-299 |
Complete |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
09/17/2018 |
Orthopedic |
11-335 |
Complete |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
04/04/2016 |
Orthopedic |
11-304 |
Complete |
ASTM |
F3107-14 |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
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)] |
08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
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 |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
06/07/2021 |
Orthopedic |
11-377 |
Complete |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
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 |
11-404 |
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 |
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 |
07/06/2020 |
Orthopedic |
11-364 |
Complete |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
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 |
07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
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 |
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 |
04/04/2016 |
Orthopedic |
11-247 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
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 |