|
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)
|
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
12/19/2022 |
General Plastic Surgery/ General Hospital |
6-485 |
Complete |
ISO |
7886-4 Second Edition 2018-11 |
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-441 |
Complete |
ISO |
7886-3 Second edition 2020-05 |
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-439 |
Complete |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-404 |
Complete |
ISO |
7886-1 Second edition 2017-05 |
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-379 |
Complete |
ISO |
7864 Fourth edition 2016-08-01 |
Sterile hypodermic needles for single use - Requirements and test methods |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
12/23/2016 |
InVitro Diagnostics |
7-267 |
Complete |
CLSI |
C24 4th Edition (Replaces C24-A3) |
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
06/07/2021 |
Orthopedic |
11-379 |
Complete |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
07/09/2014 |
Software/ Informatics |
13-65 |
Complete |
UL ANSI |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
03/08/2004 |
InVitro Diagnostics |
7-86 |
Complete |
CLSI |
C29-A2 (Replaces C29-A) |
Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition |
12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
09/17/2018 |
General I (QS/ RM) |
5-42 |
Complete |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
01/14/2019 |
Orthopedic |
11-346 |
Complete |
ASTM |
F2706-18 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
01/30/2014 |
Sterility |
14-402 |
Complete |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
08/06/2013 |
Cardiovascular |
3-87 |
Complete |
ASTM |
F2477-07 (Reapproved 2013) |
Standard Test Methods for in vitro Pulsatile Durability |
08/21/2017 |
Materials |
8-451 |
Complete |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
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 |
01/27/2015 |
ObGyn/ Gastroenterology/ Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
12/21/2020 |
Orthopedic |
11-330 |
Partial |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
12/20/2021 |
Orthopedic |
11-385 |
Complete |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-354 |
Complete |
ASTM |
D7907-14 (Reapproved 2019) |
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
04/04/2016 |
Materials |
8-136 |
Complete |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
12/23/2016 |
Materials |
8-441 |
Complete |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
12/19/2022 |
Sterility |
14-581 |
Complete |
ASTM |
F2638-22 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
09/17/2018 |
Materials |
8-476 |
Complete |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
07/09/2014 |
Sterility |
14-435 |
Complete |
ASTM |
F2251-13 (Reapproved 2023) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
05/29/2023 |
Materials |
8-601 |
Complete |
ASTM |
F2516-22 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
07/15/2019 |
Materials |
8-506 |
Complete |
ASTM |
F2516-18 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
06/07/2018 |
Materials |
8-113 |
Complete |
ASTM |
F1147-05 (Reapproved 2017)e1 |
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
04/04/2016 |
Materials |
8-116 |
Complete |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
04/04/2016 |
Materials |
8-115 |
Complete |
ASTM |
F2256-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading |
04/04/2016 |
Materials |
8-114 |
Complete |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
08/21/2017 |
Orthopedic |
11-280 |
Complete |
ASTM |
F2624-12 (Reapproved 2020) |
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |