|
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)
|
01/14/2019 |
Radiology |
12-321 |
Complete |
ANSI IES |
RP-27.3-17 |
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
01/27/2015 |
Neurology |
17-13 |
Complete |
IEEE |
Std 2010-2012 |
Recommended Practice for Neurofeedback Systems |
01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
12/20/2021 |
InVitro Diagnostics |
7-309 |
Complete |
ISO |
17099 First edition 2014-11-15 |
Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
01/15/2013 |
InVitro Diagnostics |
7-238 |
Complete |
CLSI |
MM06-A2 (Replaces MM06-A) |
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition |
01/30/2014 |
InVitro Diagnostics |
7-220 |
Partial |
CLSI |
H59-A (Replaces H59-P) |
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
08/21/2017 |
Radiology |
12-306 |
Complete |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
01/30/2014 |
InVitro Diagnostics |
7-223 |
Complete |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
01/27/2015 |
InVitro Diagnostics |
7-250 |
Partial |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
01/14/2019 |
InVitro Diagnostics |
7-178 |
Complete |
CLSI |
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; 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. |
08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
08/21/2017 |
Materials |
8-459 |
Complete |
SAE |
AMS2750 Rev. E 2012-07 |
Pyrometry |
06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
07/09/2014 |
Sterility |
14-286 |
Complete |
ANSI AAMI |
ST65:2008/(R)2018 |
Processing of reusable surgical textiles for use in health care facilities |
05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
05/30/2022 |
Sterility |
14-578 |
Partial |
ISO |
17664-1 First edition 2021-07 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
08/20/2012 |
InVitro Diagnostics |
7-148 |
Complete |
CLSI |
M28-A2 (Replaces M28-A) |
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. |
07/09/2014 |
InVitro Diagnostics |
7-213 |
Complete |
CLSI |
GP44-A4 (Formerly H18-A4) |
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
10/04/2004 |
InVitro Diagnostics |
7-105 |
Complete |
CLSI |
H30-A2 |
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
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. |
06/27/2016 |
Software/ Informatics |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
12/23/2019 |
Software/ Informatics |
13-112 |
Complete |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
08/14/2015 |
InVitro Diagnostics |
7-257 |
Complete |
CLSI |
M56-A |
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
03/18/2009 |
InVitro Diagnostics |
7-189 |
Complete |
CLSI |
M47-A (Replaces M47-P) |
Principles and Procedures for Blood Cultures; Approved Guideline |
01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
08/21/2017 |
General II (ES/ EMC) |
19-24 |
Complete |
IEC |
60086-5 Edition 4.0 2016-07 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte |
06/07/2021 |
General II (ES/ EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
03/08/2004 |
InVitro Diagnostics |
7-88 |
Complete |
CLSI |
C37-A |
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
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 |
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 |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
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 |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-464 |
Complete |
ISO |
11040-4 Third edition 2015-04-01 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
01/30/2014 |
Sterility |
14-429 |
Complete |
ISO ASTM |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
08/14/2015 |
Sterility |
14-463 |
Complete |
ISO ASTM |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
08/14/2015 |
Sterility |
14-464 |
Complete |
ISO ASTM |
51649 Third edition 2015-03-15 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
08/06/2013 |
Sterility |
14-381 |
Complete |
ISO ASTM |
51261 Second edition 2013-04-15 |
Practice for calibration of routine dosimetry systems for radiation processing |
09/09/2008 |
Software/ Informatics |
13-14 |
Complete |
CLSI |
POCT1-A2 |
Point-of-Care Connectivity |
12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
07/09/2014 |
Dental/ ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
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 |
03/31/2006 |
Radiology |
12-136 |
Complete |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
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 |
08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
06/07/2021 |
InVitro Diagnostics |
7-292 |
Partial |
CLSI |
M62 1st Edition |
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes |
05/29/2023 |
InVitro Diagnostics |
7-317 |
Partial |
CLSI |
M100, 33rd Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
09/17/2018 |
InVitro Diagnostics |
7-280 |
Complete |
CLSI |
M02 13th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
12/19/2022 |
InVitro Diagnostics |
7-314 |
Partial |
CLSI |
M27M44S, 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Yeasts |
06/07/2021 |
InVitro Diagnostics |
7-307 |
Complete |
CLSI |
POCT05 2nd Edition |
Performance Metrics for Continuous Interstitial Glucose Monitoring |
07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
06/07/2021 |
Radiology |
12-337 |
Complete |
NEMA |
NU 1-2018 |
Performance Measurements of Gamma Cameras |
06/07/2021 |
Dental/ ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
12/18/2023 |
Sterility |
14-595 |
Complete |
ISO |
11607-2 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]. |
07/15/2019 |
Sterility |
14-531 |
Complete |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
12/18/2023 |
Sterility |
14-594 |
Complete |
ISO |
11607-1 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] |
07/15/2019 |
Sterility |
14-530 |
Complete |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
01/27/2015 |
Sterility |
14-456 |
Complete |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
05/29/2023 |
Sterility |
14-585 |
Complete |
AAMI ISO |
TIR16775:2023 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 Second edition 2021-11 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
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 |
07/06/2020 |
General I (QS/ RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
12/20/2021 |
Dental/ ENT |
4-287 |
Complete |
ANSI ADA |
Standard No. 116-2020 |
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
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 |
12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
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 |
08/02/2011 |
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 |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
06/07/2018 |
Radiology |
12-314 |
Complete |
ISO |
11554 Fourth edition 2017-07 |
Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics |
01/14/2019 |
Radiology |
12-324 |
Complete |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
12/23/2019 |
Radiology |
12-327 |
Complete |
ISO |
11551 Third eidtion 2019-10 |
Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components |
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 |
01/14/2019 |
Ophthalmic |
10-85 |
Partial |
ISO |
11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
09/17/2018 |
Ophthalmic |
10-112 |
Complete |
ISO |
11986 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
09/17/2018 |
Ophthalmic |
10-111 |
Complete |
ISO |
11981 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
08/06/2013 |
Ophthalmic |
10-77 |
Complete |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
09/21/2016 |
Ophthalmic |
10-101 |
Complete |
ISO |
18189 First edition 2016-06-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
06/07/2018 |
Ophthalmic |
10-107 |
Complete |
ISO |
18369-4 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
06/07/2018 |
Ophthalmic |
10-106 |
Complete |
ISO |
18369-3 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
01/14/2019 |
Ophthalmic |
10-108 |
Partial |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
06/07/2018 |
Ophthalmic |
10-109 |
Complete |
ISO |
18369-1 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications |
01/14/2019 |
Ophthalmic |
10-86 |
Partial |
ISO |
14729 First edition 2001-04-15 |
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
04/04/2016 |
Ophthalmic |
10-100 |
Complete |
ISO |
18259 First Edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
08/14/2015 |
Ophthalmic |
10-97 |
Complete |
ISO |
13212 Third edition 2014-09-01 |
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |