|
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)
|
06/07/2021 |
Tissue Engineering |
15-66 |
Complete |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
12/21/2020 |
Tissue Engineering |
15-64 |
Partial |
ISO |
22442-1 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
01/14/2019 |
Tissue Engineering |
15-56 |
Complete |
ASTM |
F3224-17 |
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging |
12/23/2016 |
Tissue Engineering |
15-48 |
Complete |
ASTM |
F2605-16 |
Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
05/29/2024 |
Sterility |
14-603 |
Complete |
AAMI |
TIR28:2016/(R)2020 |
Product adoption and process equivalence for ethylene oxide sterilization |
05/29/2024 |
Sterility |
14-602 |
Complete |
AAMI |
TIR12:2020/(R)2023 |
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
05/29/2024 |
Sterility |
14-601 |
Complete |
ISO |
17665 First edition 2024-03 |
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
05/29/2024 |
Sterility |
14-600 |
Complete |
ASTM |
F1929-23 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
05/29/2024 |
Sterility |
14-599 |
Complete |
ISO |
14644-9 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration |
05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |