|
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 |
Radiology |
12-295 |
Partial |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
06/07/2021 |
Ophthalmic |
10-125 |
Partial |
ISO |
11979-7 Fourth edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
05/29/2024 |
Anesthesiology |
1-173 |
Partial |
ISO |
18562-1 Second edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
05/29/2024 |
Anesthesiology |
1-179 |
Partial |
ISO |
26782 First edition 2009-07 |
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] |
05/29/2023 |
Dental/ ENT |
4-305 |
Partial |
ISO |
10637 Second edition 2018-05 |
Dentistry - Central suction source equipment |
ANSI ADA |
Standard No. 177-2020 |
Central Suction Source Equipment |
06/07/2018 |
Anesthesiology |
1-137 |
Partial |
ISO |
18562-4 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
12/23/2019 |
Cardiovascular |
3-163 |
Partial |
ISO |
18242 First edition 2016-09-01 |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
09/17/2018 |
Ophthalmic |
10-56 |
Partial |
ANSI |
Z80.12-2007 (R2022) |
American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
12/18/2023 |
Biocompatibility |
2-303 |
Partial |
ISO |
10993-17 Second edition 2023-09 |
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
12/18/2023 |
Cardiovascular |
3-126 |
Partial |
IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |