|
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)
|
12/18/2023 |
Sterility |
14-595 |
Complete |
ISO |
11607-2 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]. |
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)] |
12/18/2023 |
Sterility |
14-593 |
Complete |
ASTM |
F3039-23 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
12/18/2023 |
Sterility |
14-590 |
Complete |
ISO |
14644-8 Third edition 2022-06 |
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) |
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 |
05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
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 |