|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
01/30/2014 |
Biocompatibility |
2-205 |
ANSI AAMI ISO |
14155:2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)] |
ISO |
14155 Second edition 2011-02-01 |
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)] |
07/26/2016 |
Biocompatibility |
2-213 |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
07/26/2016 |
Biocompatibility |
2-214 |
ASTM |
F619-14 |
Standard Practice for Extraction of Medical Plastics |
07/26/2016 |
Biocompatibility |
2-222 |
ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
07/26/2016 |
Biocompatibility |
2-227 |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
07/26/2016 |
Biocompatibility |
2-228 |
ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
07/26/2016 |
Biocompatibility |
2-237 |
ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
07/26/2016 |
Biocompatibility |
2-238 |
ANSI AAMI |
BE83:2006/(R)2011 |
Biological evaluation of medical devices - Part 18: Chemical characterization of materials |
07/26/2016 |
Biocompatibility |
2-240 |
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 |
2-241 |
ANSI AAMI ISO |
/TR 37137:2014 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |
ISO |
/TR 37137 First edition 2014-05-15 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |