|
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)
|
12/23/2016 |
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 |
08/14/2015 |
Sterility |
14-464 |
Complete |
ISO ASTM |
51649 Third edition 2015-03-15 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
08/14/2015 |
Sterility |
14-465 |
Complete |
ISO ASTM |
51707 Third edition 2015-03-15 |
Guide for estimating uncertainties in dosimetry for radiation processing |
07/15/2019 |
Sterility |
14-529 |
Complete |
ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
ANSI AAMI ISO |
11135:2014/A1:2018 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release |
05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
07/06/2020 |
Sterility |
14-543 |
Complete |
ISO |
11139 First edition 2018-08 |
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
07/06/2020 |
Sterility |
14-544 |
Complete |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
12/23/2019 |
Sterility |
14-538 |
Complete |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |