|
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 |
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 |
06/07/2018 |
Biocompatibility |
2-249 |
Complete |
ISO |
10993-16 Third edition 2017-05 |
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
09/17/2018 |
Biocompatibility |
2-255 |
Complete |
ISO |
10993-11 Third edition 2017-09 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
ANSI AAMI ISO |
10993-11: 2017 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
05/29/2023 |
Biocompatibility |
2-299 |
Complete |
ASTM |
F1904-23 |
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
07/26/2016 |
Biocompatibility |
2-213 |
Complete |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
05/29/2023 |
Biocompatibility |
2-300 |
Complete |
ISO |
10993-2 Third edition 2022-11 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
06/07/2018 |
Biocompatibility |
2-250 |
Complete |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
12/20/2021 |
Biocompatibility |
2-293 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Elution Test |
08/21/2017 |
Biocompatibility |
2-155 |
Complete |
ASTM |
F2147-01 (Reapproved 2016) |
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |