|
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)
|
01/30/2014 |
Sterility |
14-336 |
Partial |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
08/14/2015 |
Sterility |
14-460 |
Partial |
ISO |
11140-1 Third edition 2014-11-01 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
ANSI AAMI ISO |
11140-1:2014 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
12/23/2019 |
Software/ Informatics |
13-111 |
Complete |
IEEE |
Std 11073-10201-2018 |
Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
01/14/2019 |
Software/ Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
06/27/2016 |
Software/ Informatics |
13-84 |
Complete |
ISO IEEE |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |