|
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 |
14-169 |
Complete |
ASTM |
F2391-05 (Reapproved 2016) |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
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 |
09/17/2018 |
Sterility |
14-516 |
Complete |
ASTM |
F3039-15 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
05/29/2023 |
Sterility |
14-585 |
Complete |
AAMI ISO |
TIR16775:2023 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 Second edition 2021-11 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
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 |
07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
08/21/2017 |
Sterility |
14-502 |
Complete |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |