|
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)
|
08/02/2011 |
Ophthalmic |
10-66 |
Complete |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
03/16/2012 |
Anesthesiology |
1-73 |
Complete |
ISO |
10651-4 First edition 2002-03-01 |
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
03/16/2012 |
Cardiovascular |
3-96 |
Complete |
ISO |
81060-1 First edition 2007-12-01 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
ANSI AAMI ISO |
81060-1:2007/(R)2013 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
03/16/2012 |
Radiology |
12-232 |
Complete |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
03/16/2012 |
Radiology |
12-242 |
Complete |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
08/20/2012 |
Cardiovascular |
3-104 |
Complete |
ASTM |
F2914-12 (Reapproved 2018) |
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
01/15/2013 |
InVitro Diagnostics |
7-235 |
Complete |
CLSI |
EP25-A (Replaces EP25-P) |
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |