|
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)
|
12/23/2016 |
InVitro Diagnostics |
7-268 |
Partial |
CLSI |
EP21 2nd Edition (Replaces EP21-A) |
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
08/14/2015 |
Neurology |
17-4 |
Partial |
ASTM |
F647-94 (Reapproved 2014) |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-443 |
Partial |
ASTM |
D3577-19 |
Standard Specification for Rubber Surgical Gloves |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-445 |
Partial |
ASTM |
D5250-19(2023) |
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
12/18/2023 |
General Plastic Surgery/ General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
12/18/2023 |
InVitro Diagnostics |
7-320 |
Partial |
CLSI |
H62 1st Edition |
Validation of Assays Performed by Flow Cytometry |
08/21/2017 |
Software/ Informatics |
13-92 |
Partial |
ISO IEEE |
11073-10421 First edition 2012-11-01 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
09/17/2018 |
Materials |
8-473 |
Partial |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
07/26/2016 |
Biocompatibility |
2-169 |
Partial |
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 |
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 |