|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/21/2020 |
Sterility |
14-558 |
USP |
43-NF38:2020 |
<1229.5> Biological Indicators for Sterilization |
01/15/2013 |
Sterility |
14-313 |
ASTM |
F2475-11 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
07/06/2020 |
Sterility |
14-539 |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
07/15/2019 |
Sterility |
14-529 |
ANSI AAMI ISO |
11135:2014 |
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. |
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)] |
07/15/2019 |
Sterility |
14-530 |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
07/15/2019 |
Sterility |
14-531 |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
07/09/2014 |
Sterility |
14-432 |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
07/09/2014 |
Sterility |
14-433 |
ASTM |
F2227-13 |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method |
01/15/2013 |
Sterility |
14-212 |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-213 |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |