|
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)
|
07/06/2020 |
Biocompatibility |
2-276 |
Partial |
ISO |
10993-18 Second edition 2020-01 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process. |
12/18/2023 |
Biocompatibility |
2-303 |
Partial |
ISO |
10993-17 Second edition 2023-09 |
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
01/14/2019 |
Biocompatibility |
2-258 |
Partial |
ISO |
10993-1 Fifth edition 2018-08 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
ANSI AAMI ISO |
10993-1: 2018 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
07/26/2016 |
Biocompatibility |
2-169 |
Partial |
ISO |
10993-13 Second edition 2010-06-15 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
ANSI AAMI ISO |
10993-13:2010/(R)2014 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
06/07/2021 |
Biocompatibility |
2-290 |
Partial |
ISO |
TS 37137-1 First edition 2021-03 |
Biological evaluation of absorbable medical devices - Part 1: General requirements. |
07/26/2016 |
Biocompatibility |
2-240 |
Partial |
ANSI AAMI ISO |
TIR 10993-20:2006 |
Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
ISO |
TS 10993-20 First edition 2006-08-01 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
07/26/2016 |
Biocompatibility |
2-237 |
Partial |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
12/20/2021 |
Biocompatibility |
2-292 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/21/2020 |
Biocompatibility |
2-279 |
Complete |
ASTM |
F750-20 |
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |