|
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)
|
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
12/23/2016 |
Biocompatibility |
2-245 |
Complete |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
07/26/2016 |
Biocompatibility |
2-174 |
Complete |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
07/26/2016 |
Biocompatibility |
2-191 |
Partial |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |