|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
08/06/2013 |
Physical Medicine |
16-190 |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
08/06/2013 |
Physical Medicine |
16-192 |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
08/14/2015 |
Physical Medicine |
16-194 |
ISO |
7176-25 First edition 2013-07-15 |
Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs |
04/04/2016 |
Physical Medicine |
16-195 |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
01/30/2014 |
Physical Medicine |
16-27 |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
01/30/2014 |
Physical Medicine |
16-163 |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
01/30/2014 |
Physical Medicine |
16-165 |
ISO |
7176-14 Second edition 2008-02-15 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
12/19/2022 |
Physical Medicine |
16-233 |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
06/07/2018 |
Physical Medicine |
16-201 |
ISO |
7176-19 Second Edition 2008-07-15 |
Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] |
12/23/2016 |
Physical Medicine |
16-199 |
ISO |
7176-28 First edition 2012-10-1 |
Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |
01/30/2014 |
Physical Medicine |
16-25 |
ISO |
7176-13 First edition 1989-08-01 |
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces |
08/06/2013 |
Physical Medicine |
16-191 |
ISO |
7176-16 Second edition 2012-12-01 |
Wheelchairs - Part 16: Resistance to ignition of postural support devices |
01/30/2014 |
Physical Medicine |
16-162 |
ISO |
7176-4 Third edition 2008-10-01 |
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
12/20/2021 |
Physical Medicine |
16-232 |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
12/23/2019 |
Physical Medicine |
16-222 |
ANSI RESNA |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
04/04/2016 |
Physical Medicine |
16-196 |
ISO |
7176-7 First Edition 1998-05-15 |
Wheelchairs - Part 7: Measurement of seating and wheel dimensions |
04/04/2016 |
Physical Medicine |
16-197 |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
04/04/2016 |
Physical Medicine |
16-198 |
ISO |
7176-22 Second edition 2014-09-01 |
Wheelchairs - Part 22: Set-up procedures |
01/30/2014 |
Physical Medicine |
16-164 |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-216 |
ANSI RESNA |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-217 |
ANSI RESNA |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
12/23/2019 |
Physical Medicine |
16-220 |
ANSI RESNA |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
12/23/2019 |
Physical Medicine |
16-221 |
ANSI RESNA |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
12/23/2019 |
Physical Medicine |
16-207 |
ANSI RESNA |
WC-1:2019 Section 1 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability |
06/07/2021 |
Physical Medicine |
16-231 |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
12/23/2019 |
Physical Medicine |
16-208 |
ANSI RESNA |
WC-2:2019 Section 2 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-212 |
ANSI RESNA |
WC-2:2019 Section 6 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs. |
12/23/2019 |
Physical Medicine |
16-210 |
ANSI RESNA |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
12/23/2019 |
Physical Medicine |
16-211 |
ANSI RESNA |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
05/30/2022 |
Physical Medicine |
16-166 |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
12/21/2020 |
Orthopedic |
11-330 |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
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 |
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)] |
07/15/2019 |
Orthopedic |
11-350 |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
12/21/2020 |
Orthopedic |
11-375 |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
06/07/2021 |
Orthopedic |
11-377 |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
12/19/2022 |
Orthopedic |
11-395 |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
06/27/2016 |
Orthopedic |
11-306 |
ASTM |
F1814-15 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
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 |
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 |
11-311 |
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 |
11-232 |
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 |
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 |
08/14/2015 |
Orthopedic |
11-290 |
ISO |
8828 Second edition 2014-11-15 |
Implants for surgery -- Guidance on care and handling of orthopaedic implants |
12/19/2022 |
Orthopedic |
11-396 |
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)] |
12/19/2022 |
Orthopedic |
11-398 |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
09/17/2018 |
Orthopedic |
11-335 |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
12/20/2021 |
Orthopedic |
11-387 |
ASTM |
F1781-21 |
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)] |
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 |
12/19/2022 |
Orthopedic |
11-397 |
ASTM |
F3210-22e1 |
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
07/15/2019 |
Orthopedic |
11-357 |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
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 |
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)] |
09/17/2018 |
Orthopedic |
11-310 |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
09/17/2018 |
Orthopedic |
11-334 |
ASTM |
F1829-17 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
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 |
12/20/2021 |
Orthopedic |
11-388 |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
12/20/2021 |
Orthopedic |
11-392 |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
01/27/2015 |
Orthopedic |
11-281 |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
12/19/2022 |
Orthopedic |
11-394 |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
01/30/2014 |
Orthopedic |
11-264 |
ASTM |
F1820-13 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
08/06/2013 |
Orthopedic |
11-254 |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
12/20/2021 |
Orthopedic |
11-391 |
ASTM |
F2722 - 21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
12/20/2021 |
Orthopedic |
11-385 |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
12/20/2021 |
Orthopedic |
11-386 |
ASTM |
F2665-21 |
Standard Specification for Total Ankle Replacement Prosthesis |
01/14/2019 |
Orthopedic |
11-346 |
ASTM |
F2706-18 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
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 |
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 |
11-274 |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
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 |
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 |
08/14/2015 |
Orthopedic |
11-294 |
ASTM |
F1357 -14 (Reapproved 2019) |
Standard Specification for Articulating Total Wrist Implants |
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 |
04/04/2016 |
Orthopedic |
11-301 |
ASTM |
F2091-15 |
Standard Specification for Acetabular 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 |
07/15/2019 |
Orthopedic |
11-349 |
ISO |
14242-3 First edition 2009-03-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
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 |
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 |
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 |
07/06/2020 |
Orthopedic |
11-363 |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
09/17/2018 |
Orthopedic |
11-333 |
ASTM |
F382-17 |
Standard Specification and Test Method for Metallic Bone Plates |
06/07/2021 |
Orthopedic |
11-384 |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
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 |
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 |
09/17/2018 |
Orthopedic |
11-337 |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic 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 |
09/17/2018 |
Orthopedic |
11-339 |
ISO |
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
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 |
04/04/2016 |
Orthopedic |
11-247 |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |