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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
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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
 
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