|
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)
|
07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
07/06/2020 |
Sterility |
14-544 |
Complete |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
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 |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
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 |
14-540 |
Complete |
ISO |
11737-2 Third edition 2019-12 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
ANSI AAMI ISO |
11737-2:2019 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
07/06/2020 |
Sterility |
14-539 |
Complete |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
12/23/2019 |
Sterility |
14-538 |
Complete |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |
07/15/2019 |
Sterility |
14-533 |
Complete |
ISO |
TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
07/15/2019 |
Sterility |
14-532 |
Complete |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |