|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 04/04/2016 |
General I (QS/
RM) |
5-98 |
ANSI ESD |
S20.20-2014 |
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) |
| 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 |
| 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 |
8-503 |
ASTM |
F2042-18 |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication |
| 07/15/2019 |
Materials |
8-506 |
ASTM |
F2516-18 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
| 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 |
| 07/15/2019 |
Materials |
8-509 |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
| 12/23/2019 |
Physical Medicine |
16-226 |
ANSI RESNA |
WC-4:2017 Section 10 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers. |
| 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 |
| 08/21/2017 |
Tissue Engineering |
15-49 |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| 04/04/2016 |
Materials |
8-415 |
ASTM |
F2778-09 (Reapproved 2020) |
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-390 |
ANSI AAMI IEC |
80601-2-35:2009/A1:2016 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use |
| IEC |
80601-2-35 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)] |
| 08/21/2017 |
Software/
Informatics |
13-88 |
IEEE ISO |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
| 07/06/2020 |
Sterility |
14-542 |
ASTM ISO |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 07/15/2019 |
Anesthesiology |
1-126 |
ISO |
11712 First edition 2009-05-15 |
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| 07/15/2019 |
Anesthesiology |
1-142 |
ISO |
10079-1 Third Edition 2015-11-01 |
Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)] |
| 12/23/2019 |
Materials |
8-480 |
ASTM |
F2063-18 |
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| 12/23/2019 |
Radiology |
12-317 |
IEC |
60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 07/15/2019 |
Tissue Engineering |
15-58 |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| 07/06/2020 |
Software/
Informatics |
13-114 |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 07/06/2020 |
Software/
Informatics |
13-115 |
IEC IEEE ISO |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
| 12/23/2019 |
Materials |
8-481 |
ASTM |
F1314-18 |
Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
| 12/23/2019 |
Materials |
8-484 |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 01/14/2019 |
Cardiovascular |
3-158 |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 08/21/2017 |
Cardiovascular |
3-149 |
ISO |
25539-1 Second edition 2017-02 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 07/15/2019 |
Materials |
8-513 |
ISO |
20160 First edition 2006-05-01 |
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars |
| 07/15/2019 |
General II (ES/
EMC) |
19-35 |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
| 01/14/2019 |
Software/
Informatics |
13-105 |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
| 12/23/2019 |
Software/
Informatics |
13-111 |
IEEE |
Std 11073-10201-2018 |
Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-255 |
ANSI ADA |
Standard No. 131-2015 |
Dental CAD/CAM Machinable Zirconia Blanks |
| 01/14/2019 |
Cardiovascular |
3-126 |
ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
| 07/15/2019 |
Biocompatibility |
2-265 |
ASTM |
F2901-19 |
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| 01/14/2019 |
Nanotechnology |
18-7 |
ASTM |
E2834-12 (Reapproved 2018) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) |
| 12/23/2019 |
Orthopedic |
11-362 |
ISO |
22622 First edition 2019-07 |
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-424 |
ASTM |
D5151-19 |
Standard Test Method for Detection of Holes in Medical Gloves |
| 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 |
General I (QS/
RM) |
5-124 |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 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 |
Radiology |
12-102 |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
| 12/23/2016 |
Biocompatibility |
2-94 |
ASTM |
F981-04 (Reapproved 2016) |
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| 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 |
Radiology |
12-270 |
IEC |
61223-3-5 First edition 2004-08 |
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)] |
| 07/15/2019 |
Materials |
8-510 |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
| 01/14/2019 |
InVitro Diagnostics |
7-232 |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| 08/06/2013 |
Software/
Informatics |
13-38 |
ANSI AAMI IEC |
80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC |
80001-1 Edition 1.0 2010-10 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| 01/30/2014 |
Software/
Informatics |
13-63 |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
| IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-421 |
ISO |
80601-2-56 Second edition 2017-03 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
| 07/26/2016 |
Biocompatibility |
2-213 |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
| 01/14/2019 |
Neurology |
17-14 |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 01/14/2019 |
Physical Medicine |
16-204 |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs |
| 01/14/2019 |
Cardiovascular |
3-79 |
ASTM |
F2079-09 (Reapproved 2017) |
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| 07/15/2019 |
Sterility |
14-527 |
ASTM |
F2638-18 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
| 12/21/2020 |
Dental/
ENT |
4-266 |
ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| 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)] |
| 06/07/2021 |
Biocompatibility |
2-289 |
ISO |
10993-12 Fifth edition 2021-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| 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 |
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 |
| 12/23/2019 |
Materials |
8-524 |
ASTM |
F3276-19 |
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device |
| 12/23/2016 |
General I (QS/
RM) |
5-114 |
ANSI AAMI IEC |
62366-1:2015 |
Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC |
62366-1 Edition 1.0 2015-02 |
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] |
| 08/21/2017 |
Software/
Informatics |
13-93 |
IEEE |
Std 11073-10422-2016 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| 08/21/2017 |
Materials |
8-453 |
ASTM |
F1295-16 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 08/21/2017 |
Dental/
ENT |
4-233 |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 08/21/2017 |
Software/
Informatics |
13-90 |
IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
| 08/21/2017 |
Sterility |
14-501 |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
| 09/17/2018 |
Sterility |
14-517 |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| 01/14/2019 |
Dental/
ENT |
4-163 |
ANSI ASA |
S3.5-1997 (Reaffirmed 2020) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-120 |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
| 09/17/2018 |
Physical Medicine |
16-202 |
ISO |
7176-2 Third edition 2017-10 |
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| 09/17/2018 |
Physical Medicine |
16-203 |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 09/17/2018 |
Cardiovascular |
3-156 |
ISO |
14708-1 Second edition 2014-08-15 |
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| 09/17/2018 |
Cardiovascular |
3-154 |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| 09/17/2018 |
Sterility |
14-294 |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
| 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 |
| 09/17/2018 |
General II (ES/
EMC) |
19-31 |
ANSI IEEE |
C63.15-2017 (Revision of ANSI C63.15-2010) |
American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment |
| 09/17/2018 |
Radiology |
12-319 |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 09/17/2018 |
General I (QS/
RM) |
5-42 |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
| 09/17/2018 |
Ophthalmic |
10-57 |
ANSI |
Z80.13-2007 (R2017) |
American National Standard for Ophthalmics - Phakic Intraocular Lenses |
| 09/17/2018 |
Ophthalmic |
10-111 |
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 |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-124 |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 08/21/2017 |
Software/
Informatics |
13-94 |
IEEE ISO |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
| 01/14/2019 |
Nanotechnology |
18-11 |
ISO |
/TR 13121 First edition 2011-05-15 |
Nanotechnologies - Nanomaterial risk evaluation |
| 01/14/2019 |
Radiology |
12-322 |
NEMA |
MS 5-2018 |
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
| 07/06/2020 |
Tissue Engineering |
15-63 |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| 07/06/2020 |
Orthopedic |
11-365 |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| 07/06/2020 |
Orthopedic |
11-366 |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 01/14/2019 |
General I (QS/
RM) |
5-120 |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
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