|
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)
|
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)] |
05/29/2024 |
General Plastic Surgery/ General Hospital |
6-501 |
Complete |
ISO |
15747 Third edition 2018-09 |
Plastic containers for intravenous injections |
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 |
05/29/2024 |
General I (QS/ RM) |
5-142 |
Complete |
ISO |
780 Fifth edition 2015-12-01 |
Packaging - Distribution packaging - Graphical symbols for handling and storage of packages |
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 |