|
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)
|
07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
07/06/2020 |
Radiology |
12-325 |
Complete |
NEMA |
Standards Publication XR 25 -2019 |
Computed Tomography Dose Check |
12/23/2019 |
Dental/ ENT |
4-261 |
Complete |
ISO |
7405 Third edition 2018-10 Corrected version 2018-12 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
12/23/2019 |
Orthopedic |
11-361 |
Complete |
ISO |
14243-5 First edition 2019-05 |
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
12/21/2020 |
Biocompatibility |
2-282 |
Complete |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-426 |
Complete |
ISO |
23907-1 First edition 2019-01 |
Sharps injury protection - Requirements and test methods - Sharps containers |
07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
07/06/2020 |
Cardiovascular |
3-155 |
Complete |
IEC |
60601-2-47 Edition 2.0 2012-02 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
ANSI AAMI IEC |
60601-2-47:2012/(R)2016 |
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
08/06/2013 |
Software/ Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |