|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
07/26/2016 |
Biocompatibility |
2-133 |
ASTM |
F1408-97 (Reapproved 2013) |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
12/21/2020 |
Biocompatibility |
2-282 |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
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)] |
12/21/2020 |
Biocompatibility |
2-283 |
ASTM |
F619-20 |
Standard Practice for Extraction of Materials Used in Medical Devices |
07/26/2016 |
Biocompatibility |
2-214 |
ASTM |
F619-14 |
Standard Practice for Extraction of Medical Plastics |
12/21/2020 |
Biocompatibility |
2-284 |
USP |
43-NF38:2020 |
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/21/2020 |
Biocompatibility |
2-285 |
USP |
43-NF38:2020 |
<87> Biological Reactivity Test, In Vitro - Elution Test |
12/21/2020 |
Biocompatibility |
2-286 |
USP |
43-NF38:2020 |
<88> Biological Reactivity Tests, In Vivo |
12/21/2020 |
Biocompatibility |
2-287 |
USP |
43-NF38:2020 |
<151> Pyrogen Test (USP Rabbit Test) |
12/21/2020 |
Biocompatibility |
2-288 |
ISO |
10993-15 Second edition 2019-11 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |