|
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)
|
05/30/2022 |
Sterility |
14-573 |
Complete |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
12/18/2023 |
Sterility |
14-594 |
Complete |
ISO |
11607-1 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] |
07/15/2019 |
Sterility |
14-530 |
Complete |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
12/18/2023 |
Sterility |
14-597 |
Complete |
AAMI ANSI |
ST108:2023 |
Water for the processing of medical devices |
01/27/2015 |
Sterility |
14-456 |
Complete |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
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 |
05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
12/18/2023 |
Sterility |
14-589 |
Complete |
ISO |
14644-4 Second edition 2022-11 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
01/27/2015 |
Sterility |
14-141 |
Complete |
ISO |
14644-4 First edition 2001-04-01 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |