|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/19/2022 |
Biocompatibility |
2-296 |
ISO |
10993-10 Fourth edition 2021-11 |
Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
07/26/2016 |
Biocompatibility |
2-174 |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
07/06/2020 |
Cardiovascular |
3-155 |
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 |
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 |
01/14/2019 |
Cardiovascular |
3-126 |
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 |
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)] |
07/06/2020 |
Cardiovascular |
3-123 |
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 |
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 |