|
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 |
General I (QS/ RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
07/15/2019 |
Materials |
8-503 |
Complete |
ASTM |
F2042-18 |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication |
07/15/2019 |
Materials |
8-509 |
Complete |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
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 |
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 |
12/23/2019 |
Physical Medicine |
16-228 |
Complete |
RESNA ANSI |
WC-4:2017 Section 19 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles. |
07/15/2019 |
Materials |
8-504 |
Complete |
ASTM |
F561-19 |
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-126 |
Complete |
ISO CIE |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
07/06/2020 |
Cardiovascular |
3-167 |
Complete |
ISO |
TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |