|
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)
|
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
06/07/2018 |
Physical Medicine |
16-201 |
Complete |
ISO |
7176-19 Second Edition 2008-07-15 |
Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] |
08/06/2013 |
Software/ Informatics |
13-52 |
Complete |
ISO IEEE |
11073-10408 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
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 |
12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
05/29/2023 |
Dental/ ENT |
4-299 |
Complete |
ISO |
3107 Fifth edition 2022-09 |
Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements |
ANSI ADA |
Standard No. 30-2023 |
Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements |
01/30/2014 |
Dental/ ENT |
4-198 |
Complete |
ISO |
3107 Fourth edition 2011-03-01 |
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
ANSI ADA |
Standard No. 30-2013 (R2018) |
Dental Zinc Oxide-Eugenol and Zinc Oxide |
05/29/2023 |
Dental/ ENT |
4-300 |
Complete |
ISO |
22674 Third edition 2022-08 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
ANSI ADA |
Standard No. 134-2023 |
Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances |
07/15/2019 |
General Plastic Surgery/ General Hospital |
6-423 |
Complete |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
12/19/2007 |
Radiology |
12-176 |
Complete |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
09/09/2008 |
InVitro Diagnostics |
7-21 |
Complete |
CLSI |
C42-A |
Erythrocyte Protoporphyrin Testing; Approved Guideline |
09/09/2008 |
InVitro Diagnostics |
7-136 |
Complete |
CLSI |
I/LA2-A2 (Replaces I/LA2-A) |
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition. |
09/09/2008 |
InVitro Diagnostics |
7-159 |
Complete |
CLSI |
H21-A5 |
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
09/09/2008 |
InVitro Diagnostics |
7-163 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
04/04/2016 |
Dental/ ENT |
4-222 |
Complete |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
ANSI ADA |
Standard No. 39-2020 |
Pit and Fissure Sealants |
09/09/2008 |
ObGyn/ Gastroenterology/ Urology |
9-7 |
Complete |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
05/30/2022 |
Materials |
8-588 |
Complete |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
05/30/2022 |
Materials |
8-583 |
Complete |
ASTM |
F562-22 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
12/20/2021 |
Materials |
8-566 |
Complete |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
12/20/2021 |
Materials |
8-567 |
Complete |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
12/20/2021 |
Materials |
8-568 |
Complete |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
12/20/2021 |
Materials |
8-569 |
Complete |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
09/09/2008 |
Sterility |
14-142 |
Complete |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
09/08/2009 |
Software/ Informatics |
13-29 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
03/18/2009 |
InVitro Diagnostics |
7-170 |
Complete |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
03/18/2009 |
InVitro Diagnostics |
7-176 |
Complete |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-180 |
Complete |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-182 |
Complete |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
03/18/2009 |
InVitro Diagnostics |
7-185 |
Complete |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
03/18/2009 |
General Plastic Surgery/ General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
09/11/2023 |
Orthopedic |
11-400 |
Complete |
ISO |
21536 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
03/18/2009 |
InVitro Diagnostics |
7-71 |
Complete |
CLSI |
H15-A3 (Replaces H15-A2) |
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
03/18/2009 |
Software/ Informatics |
13-25 |
Complete |
CLSI |
AUTO8-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
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 |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
09/09/2008 |
Software/ Informatics |
13-12 |
Complete |
CLSI |
AUTO4-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-13 |
Complete |
CLSI |
AUTO5-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-14 |
Complete |
CLSI |
POCT1-A2 |
Point-of-Care Connectivity |
09/09/2008 |
Software/ Informatics |
13-17 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition |
09/09/2008 |
Software/ Informatics |
13-19 |
Complete |
CLSI |
LIS04-A |
Standard Guide for Documentation of Clinical Laboratory Computer Systems |
09/09/2008 |
Software/ Informatics |
13-20 |
Complete |
CLSI |
LIS05-A |
Standand Specification for Transferring Clinical Observations Between Independent Computer Systems |
09/09/2008 |
Software/ Informatics |
13-21 |
Complete |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
09/09/2008 |
Software/ Informatics |
13-22 |
Complete |
CLSI |
LIS07-A |
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
09/09/2008 |
Software/ Informatics |
13-23 |
Complete |
CLSI |
LIS08-A |
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems |
09/09/2008 |
Software/ Informatics |
13-24 |
Complete |
CLSI |
LIS09-A |
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
09/17/2018 |
Materials |
8-412 |
Complete |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
12/18/2023 |
Materials |
8-607 |
Complete |
ASTM |
F2082/F2082M-23 |
Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
12/23/2016 |
Materials |
8-437 |
Complete |
ASTM |
F2082/F2082M-16 |
Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
05/05/2010 |
InVitro Diagnostics |
7-207 |
Complete |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
10/04/2010 |
Radiology |
12-215 |
Complete |
IEC |
62494-1 Edition 1.0 (2008-08) |
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
03/14/2011 |
Radiology |
12-217 |
Complete |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
10/04/2010 |
InVitro Diagnostics |
7-212 |
Complete |
CLSI |
EP18-A2 |
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
03/14/2011 |
Radiology |
12-221 |
Complete |
IEC |
61223-3-4 First edition 2000-03 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
03/16/2012 |
Radiology |
12-142 |
Complete |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
01/27/2015 |
Sterility |
14-390 |
Complete |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
06/07/2018 |
Radiology |
12-315 |
Complete |
NEMA |
MS 8-2016 |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
08/21/2017 |
General I (QS/ RM) |
5-107 |
Complete |
IEC |
80369-5: Edition 1.0 2016-03 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] |
ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
06/07/2018 |
Nanotechnology |
18-10 |
Complete |
ISO |
29701 First edition 2010-09-15 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test. |
12/18/2023 |
Orthopedic |
11-403 |
Complete |
ASTM |
F3047M-23 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
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 |
08/20/2012 |
Cardiovascular |
3-104 |
Complete |
ASTM |
F2914-12 (Reapproved 2018) |
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
08/20/2012 |
General Plastic Surgery/ General Hospital |
6-278 |
Complete |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
08/06/2013 |
Software/ Informatics |
13-57 |
Complete |
ISO IEEE |
11073-10407 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-145 |
Complete |
ASTM |
D7661-18 |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-67 |
Complete |
ASTM |
D7661-10 (Reapproved 2017) |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-146 |
Complete |
ISO |
8600-4 Third Edition 2023-01 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
07/09/2014 |
ObGyn/ Gastroenterology/ Urology |
9-94 |
Complete |
ISO |
8600-4 Second Edition 2014-03-15 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
08/20/2012 |
Anesthesiology |
1-87 |
Complete |
IEC |
60601-2-23 Edition 3.0 2011-02 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
08/20/2012 |
InVitro Diagnostics |
7-197 |
Complete |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
07/09/2014 |
Dental/ ENT |
4-177 |
Complete |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
03/16/2012 |
InVitro Diagnostics |
7-150 |
Complete |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
03/16/2012 |
Radiology |
12-106 |
Complete |
ISO |
17526 First edition 2003-06-15 |
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers |
12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
09/17/2018 |
Materials |
8-475 |
Complete |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
03/16/2012 |
Radiology |
12-245 |
Complete |
ISO |
21254-1 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles |
08/20/2012 |
General Plastic Surgery/ General Hospital |
6-242 |
Complete |
ISO |
8536-2 Third edition 2010-03-15 |
Infusion equipment for medical use - Part 2: Closures for infusion bottles |
01/15/2013 |
Sterility |
14-359 |
Complete |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |