|
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)
|
04/04/2016 |
Anesthesiology |
1-106 |
Partial |
ISO |
17510 First Edition 2015-08-01 |
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
09/17/2018 |
Ophthalmic |
10-56 |
Partial |
ANSI |
Z80.12-2007 (R2022) |
American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
12/21/2020 |
General Plastic Surgery/ General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
06/07/2021 |
Cardiovascular |
3-166 |
Partial |
ISO |
81060-2 Third edition 2018-11 |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
07/06/2020 |
Cardiovascular |
3-123 |
Partial |
IEC |
80601-2-30: Edition 2.0 2018-03 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
ANSI AAMI IEC |
80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-442 |
Partial |
ASTM |
D6977-19(2023) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
05/29/2024 |
InVitro Diagnostics |
7-321 |
Partial |
CLSI |
MM24 1st Edition |
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
09/21/2016 |
InVitro Diagnostics |
7-265 |
Partial |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |