|
|
|
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)
|
| 05/29/2024 |
Materials |
8-616 |
Complete |
ISO ASTM |
52926-2 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB |
| 05/29/2024 |
Materials |
8-617 |
Complete |
ISO ASTM |
52926-3 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB |
| 05/29/2024 |
Neurology |
17-18 |
Complete |
IEEE |
Std 2010-2023 |
Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems |
| 05/29/2024 |
Neurology |
17-19 |
Partial |
ISO |
80601-2-85 Edition 1.0 2021-03 |
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment |
| 05/29/2024 |
Ophthalmic |
10-134 |
Partial |
ISO |
10943 Fourth edition 2023-01 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 05/29/2024 |
Ophthalmic |
10-135 |
Partial |
ISO |
11979-7 Fifth edition 2024-01 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
| 05/29/2024 |
Ophthalmic |
10-136 |
Complete |
IEC |
80601-2-58 Edition 3.0 2024-03 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| ANSI AAMI IEC |
80601-2-58:2024 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| 05/29/2024 |
Radiology |
12-354 |
Complete |
NEMA |
MS 4-2023 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 05/29/2024 |
Radiology |
12-355 |
Complete |
IEC |
60601-2-57 Edition 2.0 2023-07 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use |
| 05/29/2024 |
Radiology |
12-356 |
Complete |
IEC |
60601-2-22 Edition 4.0 2019-11 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| 05/29/2024 |
Radiology |
12-357 |
Complete |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties |
| 05/29/2024 |
Radiology |
12-358 |
Complete |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display - Part 20-20: Fundamental measurement methods - Image quality |
| 05/29/2024 |
Radiology |
12-359 |
Complete |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties |
| 05/29/2024 |
Radiology |
12-360 |
Complete |
IEC |
63145-10 Edition 1.0 2023-09 |
Eyewear display - Part 10: Specifications |
| 05/29/2024 |
Radiology |
12-361 |
Complete |
ICDM |
IDMS Version 1.2 May 2023 |
Information Display Measurements Standard |
| 05/29/2024 |
Software/
Informatics |
13-132 |
Complete |
ISO IEEE |
11073-10408 Second edition 2022-12 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| IEEE |
Std 11073-10408-2019 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| 05/29/2024 |
Software/
Informatics |
13-133 |
Complete |
ISO IEEE |
11073-10415 Second edition 2022-12 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
| IEEE |
Std 11073-10415-2019 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
| 05/29/2024 |
Software/
Informatics |
13-134 |
Complete |
ISO IEEE |
11073-10404 Second edition 2022-12 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
| IEEE |
Std 11073-10404-2020 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
| 05/29/2024 |
Software/
Informatics |
13-135 |
Complete |
ISO IEEE |
11073-10407 Second edition 2022-12 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| IEEE |
Std 11073-10407-2020 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| 05/29/2024 |
Software/
Informatics |
13-136 |
Complete |
ISO IEEE |
11073-20601 Third Edition 2022-12 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol |
| ISO IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol |
| 05/29/2024 |
Software/
Informatics |
13-137 |
Complete |
IEEE |
Std 11073-10101b-2023 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 05/29/2024 |
Software/
Informatics |
13-138 |
Complete |
ISO IEEE |
11073-10700 First Edition 2024-09 |
Health informatics - Device interoperability Part 10700: Point-of-care medical device communication - Standard for base requirements for participants in a Service-oriented Device Connectivity (SDC) system |
| IEEE |
Std 11073-10700-2022 |
Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System |
| 05/29/2024 |
Software/
Informatics |
13-139 |
Complete |
ISO IEEE |
11073-10206:2024 |
Health informatics - Device interoperability Part 10206: Personal health device communication - Abstract content information model |
| IEEE |
Std 11073-10206-2022 |
Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model |
| 05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 05/29/2024 |
Sterility |
14-599 |
Complete |
ISO |
14644-9 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration |
| 05/29/2024 |
Sterility |
14-600 |
Complete |
ASTM |
F1929-23 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| 05/29/2024 |
Sterility |
14-601 |
Complete |
ISO |
17665 First edition 2024-03 |
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 05/29/2024 |
Sterility |
14-602 |
Complete |
AAMI |
TIR12:2020/(R)2023 |
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| 05/29/2024 |
Sterility |
14-603 |
Complete |
AAMI |
TIR28:2016/(R)2020 |
Product adoption and process equivalence for ethylene oxide sterilization |
| 12/18/2023 |
Anesthesiology |
1-162 |
Complete |
ISO |
10651-4 Second edition 2023-03 |
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators |
| 12/18/2023 |
Anesthesiology |
1-163 |
Complete |
ISO |
80601-2-72 Second edition 2023-06 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| 12/18/2023 |
Anesthesiology |
1-164 |
Complete |
ISO |
5361 Fourth edition 2023-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| 12/18/2023 |
Anesthesiology |
1-165 |
Complete |
ISO |
80601-2-13 Second edition 2022-04 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| 12/18/2023 |
Anesthesiology |
1-166 |
Complete |
ISO |
11195 Second edition 2018-01 |
Gas mixers for medical use - Stand-alone gas mixers |
| 12/18/2023 |
Biocompatibility |
2-302 |
Complete |
ASTM |
F981-23 |
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
| 12/18/2023 |
Biocompatibility |
2-303 |
Partial |
ISO |
10993-17 Second edition 2023-09 |
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
| 12/18/2023 |
Cardiovascular |
3-105 |
Partial |
IEC |
60601-2-25 Edition 2.0 2011-10 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| ANSI AAMI IEC |
60601-2-25:2011/(R)2016 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| 12/18/2023 |
Cardiovascular |
3-126 |
Partial |
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)] |
| 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 |
| 12/18/2023 |
Cardiovascular |
3-189 |
Complete |
ASTM |
F2942-19 |
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
| 12/18/2023 |
Cardiovascular |
3-190 |
Complete |
ISO |
PAS 7020 First edition 2023-05 |
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
| 12/18/2023 |
Dental/
ENT |
4-309 |
Complete |
ISO |
6877 Third edition 2021-09 |
Dentistry - Endodontic obturating materials |
| ANSI ADA |
Standard No. 78-2022 |
Dentistry - Endodontic Obturating Materials |
| 12/18/2023 |
Dental/
ENT |
4-310 |
Complete |
ISO |
22112 Second edition 2017-08 |
Dentistry - Artificial teeth for dental prostheses |
| ANSI ADA |
Standard No. 15-2021 |
Artificial Teeth for Dental Prostheses |
| 12/18/2023 |
Dental/
ENT |
4-311 |
Complete |
ISO |
9917-2 Third edition 2017-09 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 12/18/2023 |
Dental/
ENT |
4-312 |
Complete |
ANSI ASA |
S3.35-2021 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/18/2023 |
Dental/
ENT |
4-313 |
Complete |
ISO |
27020 Second edition 2019-06 |
Dentistry - Brackets and tubes for use in orthodontics |
| ANSI ADA |
Standard No.100-2020 |
Orthodontic Brackets and Tubes |
| 12/18/2023 |
Dental/
ENT |
4-314 |
Complete |
ISO |
7494-2 Third edition 2022-07 |
Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems |
| 12/18/2023 |
Dental/
ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
| 12/18/2023 |
Dental/
ENT |
4-316 |
Complete |
ISO |
20127 Second edition 2020-08 |
Dentistry - Physical properties of powered toothbrushes |
| ANSI ADA |
Standard No.120-2022 |
Dentistry - Physical Properties of Powered Toothbrushes |
| 12/18/2023 |
Dental/
ENT |
4-317 |
Complete |
ISO |
8325 Third edition 2023-03 |
Dentistry - Test methods for rotary instruments |
| 12/18/2023 |
Dental/
ENT |
4-318 |
Complete |
ISO |
20749 Second edition 2023-06 |
Dentistry - Pre-capsulated dental amalgam |
| 12/18/2023 |
Dental/
ENT |
4-319 |
Partial |
ISO |
17730 Second edition 2020-09 |
Dentistry - Fluoride varnishes |
| ANSI ADA |
Standard No. 117-2022 |
Dentistry - Fluoride Varnishes |
| 12/18/2023 |
Dental/
ENT |
4-320 |
Complete |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| 12/18/2023 |
Dental/
ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 12/18/2023 |
Dental/
ENT |
4-322 |
Complete |
ISO |
18675 First edition 2022-05 |
Dentistry - Machinable ceramic blanks |
| 12/18/2023 |
Dental/
ENT |
4-323 |
Complete |
ISO |
5139 First edition 2023-05 |
Dentistry - Polymer-based composite machinable blanks |
| 12/18/2023 |
Dental/
ENT |
4-324 |
Complete |
ISO |
TS 16506 First edition 2017-07 Corrected version 2018-03 |
Dentistry - Polymer-based luting materials containing adhesive components |
| 12/18/2023 |
General Plastic Surgery/
General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 12/18/2023 |
InVitro Diagnostics |
7-318 |
Complete |
CLSI |
EP25 2nd Edition |
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents |
| 12/18/2023 |
InVitro Diagnostics |
7-319 |
Complete |
CLSI |
M23 6th Edition |
Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
| 12/18/2023 |
InVitro Diagnostics |
7-320 |
Partial |
CLSI |
H62 1st Edition |
Validation of Assays Performed by Flow Cytometry |
| 12/18/2023 |
Materials |
8-605 |
Complete |
ASTM |
F1609-23 |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
| 12/18/2023 |
Materials |
8-606 |
Complete |
ASTM |
F2537-23 |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 12/18/2023 |
Materials |
8-607 |
Complete |
ASTM |
F2082/F2082M-23 |
Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
| 12/18/2023 |
Materials |
8-608 |
Complete |
ASTM |
F2214-23 |
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| 12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 12/18/2023 |
Materials |
8-610 |
Complete |
ASTM |
F601-23 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 12/18/2023 |
Nanotechnology |
18-24 |
Partial |
ASTM |
E2524-22 |
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
| 12/18/2023 |
ObGyn/
Gastroenterology/
Urology |
9-150 |
Complete |
ISO |
7439 Fourth edition 2023-04 |
Copper-bearing contraceptive intrauterine devices - Requirements and tests |
| 12/18/2023 |
Orthopedic |
11-402 |
Complete |
ASTM |
F1798-21 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 12/18/2023 |
Orthopedic |
11-403 |
Complete |
ASTM |
F3047M-23 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
| 12/18/2023 |
Orthopedic |
11-404 |
Complete |
ASTM |
F2887-23 |
Standard Specification for Total Elbow Prostheses |
| 12/18/2023 |
Orthopedic |
11-405 |
Complete |
ASTM |
F1829-23 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 12/18/2023 |
Orthopedic |
11-406 |
Complete |
ASTM |
F3141-23 |
Standard Guide for Total Knee Replacement Loading Profiles |
| 12/18/2023 |
Orthopedic |
11-407 |
Complete |
ASTM |
F3140-23 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| 12/18/2023 |
Orthopedic |
11-408 |
Complete |
ASTM |
F2777-23 |
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
| 12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
| 12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
| 12/18/2023 |
Sterility |
14-589 |
Complete |
ISO |
14644-4 Second edition 2022-11 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
| 12/18/2023 |
Sterility |
14-590 |
Complete |
ISO |
14644-8 Third edition 2022-06 |
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) |
| 12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
| 12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
| 12/18/2023 |
Sterility |
14-593 |
Complete |
ASTM |
F3039-23 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| 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)] |
| 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)]. |
| 12/18/2023 |
Sterility |
14-596 |
Complete |
ASTM |
F88/F88M-23 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 12/18/2023 |
Sterility |
14-597 |
Complete |
AAMI ANSI |
ST108:2023 |
Water for the processing of medical devices |
| 10/09/2023 |
Software/
Informatics |
13-129 |
Complete |
ISO IEC IEEE |
29119-1 Second edition 2022-01 |
Software and systems engineering - Software testing - Part 1: General concepts |
| 10/09/2023 |
Software/
Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
| 10/09/2023 |
Software/
Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
| 09/11/2023 |
Orthopedic |
11-400 |
Complete |
ISO |
21536 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants |
| 09/11/2023 |
Orthopedic |
11-401 |
Complete |
ISO |
21535 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants |
| 05/29/2023 |
Anesthesiology |
1-161 |
Complete |
ISO |
16628 Second edition 2022-06 |
Anaesthetic and respiratory equipment - Tracheobronchial tubes |
| 05/29/2023 |
Biocompatibility |
2-299 |
Complete |
ASTM |
F1904-23 |
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
| 05/29/2023 |
Biocompatibility |
2-300 |
Complete |
ISO |
10993-2 Third edition 2022-11 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| 05/29/2023 |
Biocompatibility |
2-301 |
Complete |
ASTM |
F1983-23 |
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
| 05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 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 |
| 05/29/2023 |
Cardiovascular |
3-186 |
Complete |
ISO |
14708-2 Third edition 2019-09 |
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |
| 05/29/2023 |
Cardiovascular |
3-187 |
Complete |
ISO |
14708-6 Second edition 2019-09 |
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
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