|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
01/14/2019 |
Biocompatibility |
2-258 |
ANSI AAMI ISO |
10993-1: 2018 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
ISO |
10993-1 Fifth edition 2018-08 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
07/15/2019 |
Biocompatibility |
2-263 |
ASTM |
F1903-18 |
Standard Practice for Testing for Cellular Responses to Particles in vitro |
07/15/2019 |
Biocompatibility |
2-264 |
ASTM |
F2148-18 |
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). |
07/15/2019 |
Biocompatibility |
2-265 |
ASTM |
F2901-19 |
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
07/15/2019 |
Biocompatibility |
2-266 |
ASTM |
F2382-18 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
07/15/2019 |
Biocompatibility |
2-267 |
ASTM |
F2888-19 |
Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
07/15/2019 |
Biocompatibility |
2-268 |
ISO |
/TS 21726 First edition 2019-02 |
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents |
07/06/2020 |
Biocompatibility |
2-273 |
ISO |
10993-9 Third edition 2019-11 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
07/06/2020 |
Biocompatibility |
2-274 |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
07/06/2020 |
Biocompatibility |
2-275 |
ISO |
10993-7 Second edition 2008-10-15 |
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2020)] |