|
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)
|
12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
12/20/2021 |
Cardiovascular |
3-179 |
Complete |
ASTM |
F3172-15 (Reapproved 2021) |
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
12/20/2021 |
Dental/ ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
12/20/2021 |
Dental/ ENT |
4-285 |
Complete |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
12/20/2021 |
Dental/ ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
12/20/2021 |
Dental/ ENT |
4-287 |
Complete |
ANSI ADA |
Standard No. 116-2020 |
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
12/20/2021 |
Dental/ ENT |
4-288 |
Complete |
ISO |
7488 Second edition 2018-04 |
Dentistry - Mixing machines for dental amalgam |
ANSI ADA |
Standard No. 43-2020 |
Electrically Powered Dental Amalgamators |
12/20/2021 |
Dental/ ENT |
4-289 |
Complete |
ISO |
18556 Frist edition 2016-04 |
Dentistry - Intraoral spatulas |
12/20/2021 |
Dental/ ENT |
4-290 |
Complete |
ISO |
28158 Second edition 2018-09 |
Dentistry - Integrated dental floss and handles |
ANSI ADA |
Standard No. 185-2020 |
Integrated Dental Floss and Handles |
12/20/2021 |
Dental/ ENT |
4-291 |
Complete |
ISO |
28399 First edition 2011-01 |
Dentistry - Products for external tooth bleaching |
ANSI ADA |
Standard No. 136-2015 (R2020) |
Products for External Tooth Bleaching |
12/20/2021 |
Dental/ ENT |
4-292 |
Complete |
ISO |
28888 First edition 2013-10 |
Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues |
ANSI ADA |
Standard No. 151-2015 (R2020) |
Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues |
12/20/2021 |
General I (QS/ RM) |
5-134 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
12/20/2021 |
General II (ES/ EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
12/20/2021 |
General II (ES/ EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
12/20/2021 |
General II (ES/ EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
12/20/2021 |
General II (ES/ EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-464 |
Complete |
ISO |
11040-4 Third edition 2015-04-01 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-466 |
Complete |
USP-NF |
M76070_03_01 |
Sodium Chloride Injection |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
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 |
12/20/2021 |
InVitro Diagnostics |
7-309 |
Complete |
ISO |
17099 First edition 2014-11-15 |
Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
12/20/2021 |
Materials |
8-565 |
Complete |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
12/20/2021 |
Materials |
8-566 |
Complete |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
12/20/2021 |
Materials |
8-567 |
Complete |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
12/20/2021 |
Materials |
8-568 |
Complete |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
12/20/2021 |
Materials |
8-569 |
Complete |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
12/20/2021 |
Materials |
8-570 |
Complete |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
12/20/2021 |
Materials |
8-571 |
Complete |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
12/20/2021 |
Materials |
8-572 |
Complete |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
12/20/2021 |
Materials |
8-573 |
Complete |
ASTM |
F2695-12(2020) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
12/20/2021 |
Materials |
8-575 |
Complete |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
12/20/2021 |
Nanotechnology |
18-19 |
Complete |
ISO |
19749 First edition 2021-07 |
Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy |
12/20/2021 |
Nanotechnology |
18-20 |
Complete |
ASTM |
E3275-21 |
Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis |