|
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)
|
12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
12/20/2021 |
Sterility |
14-563 |
Complete |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
06/07/2021 |
Sterility |
14-562 |
Complete |
ANSI AAMI |
ST79:2017 & 2020 Amendments A1, A2, A3, A4 |
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
12/21/2020 |
Sterility |
14-554 |
Complete |
ASTM |
F17-20 |
Standard Terminology Relating to Flexible Barrier Packaging |
12/21/2020 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |