|
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)
|
12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
12/21/2020 |
InVitro Diagnostics |
7-300 |
Complete |
CLSI |
MM13 2nd Edition |
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
12/21/2020 |
InVitro Diagnostics |
7-301 |
Complete |
CLSI |
GP42 7th Edition |
Collection of Capillary Blood Specimens |
12/21/2020 |
InVitro Diagnostics |
7-302 |
Complete |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
07/06/2020 |
Anesthesiology |
1-146 |
Complete |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
07/15/2019 |
Materials |
8-509 |
Complete |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
07/06/2020 |
Cardiovascular |
3-167 |
Complete |
ISO |
TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
07/15/2019 |
Biocompatibility |
2-267 |
Complete |
ASTM |
F2888-19 |
Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
06/07/2021 |
InVitro Diagnostics |
7-306 |
Complete |
CLSI |
EP06 2nd Edition |
Evaluation of the Linearity of Quantitative Measurement Procedures |
07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
10/04/2004 |
InVitro Diagnostics |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
03/31/2006 |
Radiology |
12-137 |
Complete |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
03/31/2006 |
Radiology |
12-138 |
Complete |
ISO |
5799 Second edition 1991-08-01 |
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
01/30/2014 |
General I (QS/ RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
11/08/2005 |
InVitro Diagnostics |
7-113 |
Complete |
CLSI |
I/LA23-A (Replaces I/LA23-P) |
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
07/15/2019 |
Dental/ ENT |
4-258 |
Complete |
ISO |
10139-2 Third edition 2016-06-15 |
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
ANSI ADA |
Standard No. 160-2020 |
Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use |
07/06/2020 |
Radiology |
12-332 |
Complete |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
03/18/2009 |
Software/ Informatics |
13-26 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-28 |
Complete |
CLSI |
AUTO9-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
03/18/2009 |
InVitro Diagnostics |
7-145 |
Complete |
CLSI |
H42-A2 (Replaces H42-A) |
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
09/09/2008 |
Radiology |
12-165 |
Complete |
NEMA |
XR 22-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography |
09/09/2008 |
Software/ Informatics |
13-9 |
Complete |
CLSI |
AUTO2-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification |
09/09/2008 |
Software/ Informatics |
13-10 |
Complete |
CLSI |
AUTO1-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
03/16/2012 |
Radiology |
12-143 |
Complete |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
03/16/2012 |
Radiology |
12-248 |
Complete |
ISO |
21254-3 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
03/16/2012 |
Radiology |
12-174 |
Complete |
ISO |
13697 First edition 2006-05-15 |
Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
03/16/2012 |
Radiology |
12-175 |
Complete |
ISO |
24013 First edition 2006-11-15 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
08/20/2012 |
Software/ Informatics |
13-31 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
08/20/2012 |
Cardiovascular |
3-102 |
Complete |
IEC |
60601-2-31 Edition 2.1 2011-09 |
Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
06/07/2021 |
Orthopedic |
11-379 |
Complete |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
07/06/2020 |
General I (QS/ RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |