|
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)
|
12/23/2019 |
Orthopedic |
11-360 |
Complete |
ASTM |
F1378-18e1 |
Standard Specification for Shoulder Prostheses |
05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
12/21/2020 |
Materials |
8-543 |
Partial |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-443 |
Partial |
ASTM |
D3577-19 |
Standard Specification for Rubber Surgical Gloves |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-440 |
Partial |
ASTM |
D3578-19(2023) |
Standard Specification for Rubber Examination Gloves |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-120 |
Complete |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
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 |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
01/14/2019 |
General Plastic Surgery/ General Hospital |
6-338 |
Complete |
ASTM |
D7866-14 |
Standard Specification for Radiation Attenuating Protective Gloves |
12/18/2023 |
General Plastic Surgery/ General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
03/18/2009 |
General Plastic Surgery/ General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
07/15/2019 |
Materials |
8-509 |
Complete |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
01/30/2014 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
09/17/2018 |
Materials |
8-475 |
Complete |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-442 |
Partial |
ASTM |
D6977-19(2023) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
07/15/2019 |
Materials |
8-510 |
Complete |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-445 |
Partial |
ASTM |
D5250-19(2023) |
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
12/23/2019 |
Materials |
8-521 |
Complete |
ASTM |
F2313-18 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-70 |
Complete |
ASTM |
E825-98 (Reapproved 2016) |
Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-492 |
Complete |
ASTM |
F2100-23 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-425 |
Complete |
ASTM |
F2100-19 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-446 |
Partial |
ASTM |
D6319-19(2023) |
Standard Specification for Nitrile Examination Gloves for Medical Application |
12/21/2020 |
Neurology |
17-17 |
Complete |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder Devices |
09/17/2018 |
Orthopedic |
11-329 |
Complete |
ASTM |
F2180-17 |
Standard Specification for Metallic Implantable Strands and Cables |
05/30/2022 |
Materials |
8-586 |
Complete |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
09/17/2018 |
Materials |
8-473 |
Partial |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
09/17/2018 |
Materials |
8-474 |
Complete |
ASTM |
F2886-17 |
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-123 |
Complete |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
08/21/2017 |
Orthopedic |
11-309 |
Complete |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
09/08/2009 |
Software/ Informatics |
13-29 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
06/07/2021 |
Orthopedic |
11-377 |
Complete |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-474 |
Partial |
ASTM |
F3352-19 |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-125 |
Complete |
ASTM |
E1965-98 (Reapproved 2016) |
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
01/14/2019 |
Materials |
8-179 |
Partial |
ASTM |
F754-08 (Reapproved 2015) |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-409 |
Complete |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
08/21/2017 |
Materials |
8-333 |
Complete |
ASTM |
F2393-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications |
08/21/2017 |
Materials |
8-226 |
Complete |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
04/04/2016 |
Orthopedic |
11-299 |
Complete |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
03/16/2012 |
General Plastic Surgery/ General Hospital |
6-177 |
Complete |
ASTM |
E1112-00(2018) |
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
12/20/2021 |
Orthopedic |
11-387 |
Complete |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-200 |
Complete |
ASTM |
E1061-01(2022) |
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
06/27/2016 |
Materials |
8-427 |
Complete |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
08/21/2017 |
Materials |
8-428 |
Complete |
ASTM |
F1581-08 (Reapproved 2020) |
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
05/30/2022 |
Materials |
8-585 |
Complete |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
12/23/2019 |
Materials |
8-520 |
Complete |
ASTM |
F799-19 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-124 |
Complete |
ASTM |
E1104-98 (Reapproved 2016) |
Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
06/07/2021 |
Materials |
8-558 |
Complete |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
01/27/2015 |
Materials |
8-171 |
Complete |
ASTM |
F1609-08 (Reapproved 2014) |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
12/18/2023 |
Materials |
8-605 |
Complete |
ASTM |
F1609-23 |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-117 |
Complete |
ASTM |
F2172-02 (Reapproved 2011) |
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
12/19/2022 |
General Plastic Surgery/ General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
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 |
12/23/2019 |
Materials |
8-508 |
Complete |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-407 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
04/04/2016 |
Materials |
8-409 |
Partial |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
12/23/2016 |
Materials |
8-439 |
Partial |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
06/27/2016 |
Materials |
8-426 |
Complete |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
04/04/2016 |
Orthopedic |
11-301 |
Complete |
ASTM |
F2091-15 |
Standard Specification for Acetabular Prostheses |
12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
09/17/2018 |
Orthopedic |
11-327 |
Complete |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
09/17/2018 |
Orthopedic |
11-333 |
Complete |
ASTM |
F382-17 |
Standard Specification and Test Method for Metallic Bone Plates |
08/21/2017 |
Materials |
8-458 |
Complete |
ASTM |
G5-14 |
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements |
08/21/2017 |
Materials |
8-195 |
Complete |
ASTM |
F2024-10 (Reapproved 2016) |
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
07/26/2016 |
Biocompatibility |
2-213 |
Complete |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
12/21/2020 |
Biocompatibility |
2-278 |
Complete |
ASTM |
F719-20 e1 |
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation |
09/17/2018 |
Biocompatibility |
2-256 |
Complete |
ASTM |
F720-17 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
01/14/2019 |
Biocompatibility |
2-141 |
Complete |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
07/15/2019 |
Biocompatibility |
2-263 |
Complete |
ASTM |
F1903-18 |
Standard Practice for Testing for Cellular Responses to Particles in vitro |
12/20/2021 |
Materials |
8-567 |
Complete |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
12/21/2020 |
Biocompatibility |
2-280 |
Complete |
ASTM |
F1408-20a |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
12/23/2016 |
Biocompatibility |
2-93 |
Complete |
ASTM |
F763-04 (Reapproved 2016) |
Standard Practice for Short-Term Screening of Implant Materials |
12/19/2022 |
Biocompatibility |
2-297 |
Complete |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
12/23/2016 |
Biocompatibility |
2-244 |
Partial |
ASTM |
F748-16 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
07/15/2019 |
Materials |
8-504 |
Complete |
ASTM |
F561-19 |
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
09/09/2008 |
Software/ Informatics |
13-21 |
Complete |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
09/17/2018 |
Materials |
8-472 |
Complete |
ASTM |
F2847-17 |
Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
07/15/2019 |
Biocompatibility |
2-267 |
Complete |
ASTM |
F2888-19 |
Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
09/17/2018 |
Orthopedic |
11-197 |
Complete |
ASTM |
F983-86 (Reapproved 2018) |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |