|
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)
|
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 |
Radiology |
12-166 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
06/07/2021 |
Sterility |
14-562 |
Complete |
ANSI AAMI |
ST79:2017 & 2020 Amendments A1, A2, A3, A4 |
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
12/20/2021 |
Sterility |
14-567 |
Complete |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
12/20/2021 |
Biocompatibility |
2-295 |
Partial |
USP-NF |
M98900_01_01 |
<151> Pyrogen Test (USP Rabbit Test) |
12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
12/20/2021 |
Sterility |
14-568 |
Complete |
USP-NF |
M98800_01_01 |
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
12/20/2021 |
Biocompatibility |
2-292 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/20/2021 |
Biocompatibility |
2-293 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Elution Test |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
12/20/2021 |
Biocompatibility |
2-294 |
Partial |
USP-NF |
M98834_01_01 |
<88> Biological Reactivity Tests, In Vivo |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
07/15/2019 |
General II (ES/ EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
03/08/2004 |
InVitro Diagnostics |
7-89 |
Complete |
CLSI |
C39-A (Replaces C39-P) |
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
09/21/2016 |
InVitro Diagnostics |
7-266 |
Complete |
CLSI |
EP19 2nd Edition (Replaces EP19-R) |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
12/23/2019 |
InVitro Diagnostics |
7-293 |
Complete |
CLSI |
QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
A Quality Management System Model for Laboratory Services. |
08/20/2012 |
InVitro Diagnostics |
7-197 |
Complete |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
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 |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
12/23/2019 |
Cardiovascular |
3-161 |
Complete |
ISO |
14117 Second edition 2019-09 |
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
01/25/2013 |
Cardiovascular |
3-89 |
Complete |
ISO |
27186 First edition 2010-03-15 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
ANSI AAMI ISO |
27186:2010 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
05/29/2023 |
Cardiovascular |
3-185 |
Partial |
ANSI AAMI |
PC76:2021 |
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
07/06/2020 |
Materials |
8-534 |
Complete |
ISO ASTM |
52911-1: First Edition 2019-07 |
Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
07/06/2020 |
Materials |
8-535 |
Complete |
ISO ASTM |
52911-2: First Edition 2019-09 |
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers |
01/14/2019 |
Materials |
8-487 |
Complete |
ISO ASTM |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
07/06/2020 |
Materials |
8-533 |
Complete |
ISO ASTM |
52907: First Edition 2019-11 |
Additive Manufacturing - Feedstock materials - Methods to characterize metal powders |
06/07/2021 |
Materials |
8-561 |
Complete |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
12/23/2016 |
Materials |
8-444 |
Complete |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
06/07/2021 |
Materials |
8-562 |
Complete |
ISO ASTM |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
06/27/2016 |
Materials |
8-434 |
Complete |
ISO ASTM |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
07/06/2020 |
Materials |
8-536 |
Complete |
ISO ASTM |
52902:First Edition 2019-07 |
Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems |
12/20/2021 |
General II (ES/ EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
08/14/2015 |
Dental/ ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2019) |
American National Standard For an Occluded Ear Simulator |
12/23/2019 |
Dental/ ENT |
4-260 |
Complete |
ANSI ASA |
S12.2-2019 |
American National Standard for Criteria for Evaluating Room Noise |
03/16/2012 |
Dental/ ENT |
4-173 |
Complete |
ANSI ASA |
S3.44-1996 (Reaffirmed 2006) |
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment |
12/19/2022 |
General II (ES/ EMC) |
19-48 |
Complete |
IEEE ANSI |
USEMCSC C63.27-2021 |
American National Standard for Evaluation of Wireless Coexistence |
07/15/2019 |
Ophthalmic |
10-89 |
Partial |
ANSI |
Z80.7-2013 (R2023) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
08/21/2017 |
Ophthalmic |
10-103 |
Complete |
ANSI |
Z80.18-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology |
08/21/2017 |
Ophthalmic |
10-104 |
Partial |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |