|
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)
|
07/26/2016 |
Biocompatibility |
2-222 |
Complete |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
07/26/2016 |
Biocompatibility |
2-227 |
Complete |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
07/26/2016 |
Biocompatibility |
2-228 |
Partial |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
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 |
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 |
07/26/2016 |
Biocompatibility |
2-243 |
Partial |
ISO |
TR 10993-33 First Edition 2015-03-01 |
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 |
12/23/2016 |
Biocompatibility |
2-244 |
Partial |
ASTM |
F748-16 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
12/23/2016 |
Biocompatibility |
2-245 |
Complete |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
08/21/2017 |
Biocompatibility |
2-246 |
Complete |
ASTM |
F1877-16 |
Standard Practice for Characterization of Particles |
08/21/2017 |
Biocompatibility |
2-247 |
Complete |
ISO |
10993-6 Third edition 2016-12-01 |
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |