|
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 |
Cardiovascular |
3-161 |
Complete |
ISO |
14117 Second edition 2019-09 |
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
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 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
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 |
12/20/2021 |
Cardiovascular |
3-173 |
Complete |
ISO |
5840-3 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
12/19/2022 |
Cardiovascular |
3-183 |
Complete |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
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 |
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 |
05/29/2023 |
Cardiovascular |
3-186 |
Complete |
ISO |
14708-2 Third edition 2019-09 |
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |