|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
01/14/2019 |
Biocompatibility |
2-145 |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
08/21/2017 |
Biocompatibility |
2-155 |
ASTM |
F2147-01 (Reapproved 2016) |
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
07/26/2016 |
Biocompatibility |
2-167 |
ANSI AAMI ISO |
TIR 10993-19:2006 |
Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials |
ISO |
/TS 10993-19 First edition 2006-06-01 |
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials |
07/26/2016 |
Biocompatibility |
2-168 |
ANSI AAMI ISO |
10993-9:2009/(R)2014 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantitication of potential degradation products |
ISO |
10993-9 Second edition 2009-12-15 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
07/26/2016 |
Biocompatibility |
2-169 |
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 |
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 |
07/26/2016 |
Biocompatibility |
2-170 |
ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
07/26/2016 |
Biocompatibility |
2-174 |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
12/23/2016 |
Biocompatibility |
2-189 |
ASTM |
F895-11 (Reapproved 2016) |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
07/26/2016 |
Biocompatibility |
2-191 |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
07/26/2016 |
Biocompatibility |
2-197 |
ASTM |
F749-13 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |