|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard
|
07/26/2016 |
Biocompatibility |
2-191 |
Partial |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
12/23/2016 |
Biocompatibility |
2-245 |
Complete |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-423 |
Complete |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |