|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/23/2019 |
Physical Medicine |
16-227 |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
12/23/2019 |
Physical Medicine |
16-229 |
ANSI RESNA |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
06/07/2021 |
Orthopedic |
11-383 |
ASTM |
F3143-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-124 |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
12/23/2019 |
Materials |
8-505 |
ISO |
6474-2 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
12/23/2019 |
Materials |
8-507 |
ASTM |
F688-19 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
08/14/2015 |
Software/ Informatics |
13-76 |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
03/16/2012 |
Radiology |
12-177 |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
03/16/2012 |
Radiology |
12-241 |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
08/06/2013 |
Radiology |
12-253 |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
08/06/2013 |
Radiology |
12-255 |
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 |
07/15/2019 |
Sterility |
14-531 |
ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
07/06/2020 |
Sterility |
14-542 |
ASTM ISO |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
09/09/2008 |
Software/ Informatics |
13-18 |
CLSI |
LIS03-A |
Standard Guide for Selection of a Clinical Laboratory Information Management System |
01/14/2019 |
InVitro Diagnostics |
7-139 |
CLSI |
QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 |
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
07/06/2020 |
Materials |
8-532 |
ASTM |
F3335-20 |
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion |
07/06/2020 |
Materials |
8-533 |
ASTM ISO |
52907: First Edition 2019-11 |
Additive Manufacturing - Feedstock materials - Methods to characterize metal powders |
12/21/2020 |
Biocompatibility |
2-282 |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
07/15/2019 |
Anesthesiology |
1-126 |
ISO |
11712 First edition 2009-05-15 |
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
07/15/2019 |
Materials |
8-518 |
ASTM |
F3306-19 |
Standard Test Method for Ion Release Evaluation of Medical Implants |
08/06/2013 |
Software/ Informatics |
13-49 |
IEEE ISO |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
01/30/2014 |
Radiology |
12-228 |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
01/30/2014 |
Radiology |
12-261 |
IEC ISO |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
01/30/2014 |
Radiology |
12-267 |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
01/14/2019 |
Anesthesiology |
1-138 |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
06/07/2021 |
Radiology |
12-339 |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
01/14/2019 |
Dental/ ENT |
4-250 |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
01/14/2019 |
Dental/ ENT |
4-251 |
ANSI ADA |
Standard No. 69-2017 |
Dental Ceramic |
ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-125 |
CIE ISO |
11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 |
Colorimetry - Part 2: CIE standard illuminants |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-127 |
CIE ISO |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
08/06/2013 |
Software/ Informatics |
13-56 |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
08/21/2017 |
Software/ Informatics |
13-67 |
IEEE ISO |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
07/15/2019 |
Materials |
8-503 |
ASTM |
F2042-18 |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication |
07/15/2019 |
Materials |
8-509 |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
10/04/2010 |
Radiology |
12-213 |
IEC |
62220-1-2 Edition 1.0 2007-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
10/04/2010 |
Radiology |
12-214 |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
07/09/2014 |
Radiology |
12-280 |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
08/14/2015 |
Radiology |
12-290 |
IEC |
61910-1 Edition 1.0 2014-09 |
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
07/15/2019 |
Materials |
8-493 |
ISO |
13779-2 Third edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite |
07/15/2019 |
Materials |
8-506 |
ASTM |
F2516-18 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-68 |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-111 |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
01/14/2019 |
Orthopedic |
11-342 |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
07/06/2020 |
Tissue Engineering |
15-59 |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
12/21/2020 |
Dental/ ENT |
4-268 |
ANSI ADA |
Standard No. 32-2017 |
Orthodontic Wires |
ISO |
15841 Second edition 2014-08 |
Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
07/15/2019 |
Sterility |
14-529 |
ANSI AAMI ISO |
11135:2014 |
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. |
ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
12/23/2019 |
Materials |
8-522 |
ASTM |
F2129-19a |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
07/15/2019 |
Sterility |
14-530 |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
07/06/2020 |
Materials |
8-534 |
ASTM ISO |
52911-1: First Edition 2019-07 |
Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
07/15/2019 |
Orthopedic |
11-357 |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
07/06/2020 |
Sterility |
14-545 |
ASTM ISO |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
07/06/2020 |
Sterility |
14-549 |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
08/21/2017 |
Biocompatibility |
2-246 |
ASTM |
F1877-16 |
Standard Practice for Characterization of Particles |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-296 |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-306 |
ASTM |
F1671/F1671M-13 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
07/06/2020 |
Materials |
8-535 |
ASTM ISO |
52911-2: First Edition 2019-09 |
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers |
07/06/2020 |
Materials |
8-536 |
ASTM ISO |
52902:First Edition 2019-07 |
Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems |
07/06/2020 |
Tissue Engineering |
15-61 |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
12/23/2019 |
Materials |
8-523 |
ASTM |
F3275-19 |
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device |
07/09/2014 |
Radiology |
12-275 |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
07/09/2014 |
Radiology |
12-281 |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-121 |
ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
12/23/2019 |
Radiology |
12-328 |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
01/14/2019 |
Ophthalmic |
10-114 |
ANSI |
Z80.28-2017 |
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes |
01/14/2019 |
Ophthalmic |
10-115 |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
01/14/2019 |
Software/ Informatics |
13-106 |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
01/14/2019 |
Software/ Informatics |
13-107 |
IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices |
ISO |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
09/17/2018 |
Sterility |
14-513 |
ASTM |
F2825-18 |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery |
01/30/2014 |
Materials |
8-358 |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
07/15/2019 |
Tissue Engineering |
15-57 |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
12/23/2019 |
Orthopedic |
11-360 |
ASTM |
F1378-18e1 |
Standard Specification for Shoulder Prostheses |
12/23/2019 |
Radiology |
12-329 |
IEC |
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
07/09/2014 |
Radiology |
12-283 |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
03/14/2011 |
Radiology |
12-226 |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
03/16/2012 |
Radiology |
12-105 |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
01/14/2019 |
Cardiovascular |
3-158 |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
01/14/2019 |
Dental/ ENT |
4-255 |
ANSI ADA |
Standard No. 131-2015 |
Dental CAD/CAM Machinable Zirconia Blanks |
07/06/2020 |
Nanotechnology |
18-15 |
ASTM |
E3025-16 |
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles |
07/15/2019 |
Orthopedic |
11-355 |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
12/23/2019 |
Physical Medicine |
16-228 |
ANSI RESNA |
WC-4:2017 Section 19 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles. |
07/15/2019 |
Materials |
8-504 |
ASTM |
F561-19 |
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
09/17/2018 |
Orthopedic |
11-327 |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
06/07/2018 |
Biocompatibility |
2-249 |
ISO |
10993-16 Third edition 2017-05 |
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
09/17/2018 |
Orthopedic |
11-340 |
ASTM |
F3018-17 |
Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-126 |
CIE ISO |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
07/06/2020 |
Cardiovascular |
3-167 |
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 |
07/06/2020 |
Cardiovascular |
3-164 |
ASTM |
F1830-19 |
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps |
03/16/2012 |
Radiology |
12-115 |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
12/23/2016 |
Radiology |
12-303 |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
12/23/2016 |
Radiology |
12-304 |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
06/27/2016 |
Materials |
8-426 |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
04/04/2016 |
Orthopedic |
11-299 |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
06/07/2021 |
Radiology |
12-337 |
NEMA |
NU 1-2018 |
Performance Measurements of Gamma Cameras |
12/23/2019 |
Cardiovascular |
3-162 |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
12/21/2020 |
Sterility |
14-554 |
ASTM |
F17-20 |
Standard Terminology Relating to Flexible Barrier Packaging |
12/23/2019 |
Materials |
8-521 |
ASTM |
F2313-18 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
07/06/2020 |
Sterility |
14-539 |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
07/06/2020 |
Materials |
8-529 |
ASTM |
F2633-19 |
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
12/23/2019 |
Materials |
8-508 |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
12/23/2019 |
Sterility |
14-538 |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |