|
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)
|
01/14/2019 |
Cardiovascular |
3-159 |
Partial |
ISO |
5910 First edition 2018-06 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
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 |
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)] |
12/21/2020 |
Cardiovascular |
3-169 |
Partial |
IEC |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
ANSI AAMI IEC |
60601-2-4:2010/A1:2018 (Consolidated Text) |
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
01/14/2019 |
Cardiovascular |
3-44 |
Complete |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
07/06/2020 |
Cardiovascular |
3-155 |
Complete |
IEC |
60601-2-47 Edition 2.0 2012-02 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
ANSI AAMI IEC |
60601-2-47:2012/(R)2016 |
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
01/14/2019 |
Cardiovascular |
3-52 |
Partial |
ANSI AAMI |
EC12:2000/(R)2015 |
Disposable ECG electrodes |
05/29/2023 |
Cardiovascular |
3-185 |
Partial |
ANSI AAMI |
PC76:2021 |
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |