|
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)
|
01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
06/27/2016 |
Software/ Informatics |
13-82 |
Complete |
ANSI AAMI ISO |
TIR 80001-2-6:2014 |
Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
12/21/2020 |
Biocompatibility |
2-277 |
Complete |
ASTM |
F813-20 |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-214 |
Complete |
ASTM |
D6355-07(2022) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
06/27/2016 |
Software/ Informatics |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
07/15/2019 |
Sterility |
14-528 |
Complete |
ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
12/23/2019 |
General I (QS/ RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |