|
|
|
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)
|
| 12/22/2025 |
Anesthesiology |
1-197 |
Complete |
ISO |
17510 Second Edition 2025-11 |
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories |
| 12/22/2025 |
Anesthesiology |
1-198 |
Complete |
ISO |
7376 Third edition 2020-08 [Including AMD1:2025] |
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)] |
| 12/22/2025 |
Anesthesiology |
1-199 |
Complete |
ISO |
80601-2-70 Third edition 2025-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 12/22/2025 |
Anesthesiology |
1-200 |
Complete |
ISO |
7376-2 First edition 2025-09 |
Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes |
| 12/22/2025 |
Anesthesiology |
1-201 |
Complete |
ISO |
19223-2 First edition 2025-04 |
Lung ventilators and related equipment - Vocabulary and semantics - Part 2: High frequency and jet ventilation. |
| 12/22/2025 |
Anesthesiology |
1-202 |
Complete |
ISO |
19223-3 First edition 2025-09 |
Lung ventilators and related equipment - Vocabulary and semantics - Part 3: Respiratory care |
| 12/22/2025 |
Biocompatibility |
2-308 |
Complete |
ASTM |
F1984-25 |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 12/22/2025 |
Biocompatibility |
2-309 |
Complete |
ASTM |
F895-25 |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
| 12/22/2025 |
Biocompatibility |
2-310 |
Complete |
ASTM |
F748-25 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 12/22/2025 |
Biocompatibility |
2-311 |
Complete |
ISO |
10993-4 Third edition 2017-04 [Including AMD1:2025] |
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)] |
| 12/22/2025 |
Biocompatibility |
2-312 |
Complete |
ASTM |
F720-24 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
| 12/22/2025 |
Cardiovascular |
3-201 |
Complete |
IEC |
60601-2-31 Edition 3.0 2020-01 |
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| 12/22/2025 |
Cardiovascular |
3-202 |
Complete |
IEC |
60601-2-34 Edition 4.0 2024-10 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| 12/22/2025 |
Cardiovascular |
3-203 |
Partial |
IEC |
80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 12/22/2025 |
Dental/
ENT |
4-348 |
Complete |
ISO |
9917-1 Third Edition 2025-05 |
Dentistry - Water-based cements - Part 1: Acid-base cements |
| 12/22/2025 |
Dental/
ENT |
4-349 |
Complete |
ANSI ADA |
Standard No. 34-2025 |
Dental Cartridge Syringes |
| 12/22/2025 |
Dental/
ENT |
4-350 |
Complete |
ANSI ASA |
S3.6-2025 |
American National Standard Specification for Audiometers |
| 12/22/2025 |
Dental/
ENT |
4-351 |
Complete |
ISO |
6877 Fourth edition 2025-08 |
Dentistry - Endodontic obturating materials |
| 12/22/2025 |
Dental/
ENT |
4-352 |
Complete |
ANSI ASA |
S3.35-2025 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/22/2025 |
Dental/
ENT |
4-353 |
Complete |
ISO |
20127 Third edition 2025-05 |
Dentistry - Physical properties of powered toothbrushes |
| 12/22/2025 |
Dental/
ENT |
4-354 |
Partial |
ISO |
17730 Third edition 2025-09 |
Dentistry - Fluoride varnishes |
| ANSI ADA |
Standard No. 117-2022 |
Dentistry - Fluoride Varnishes |
| 12/22/2025 |
Dental/
ENT |
4-355 |
Complete |
ISO |
18397 Second edition 2025-07 |
Dentistry - Powered scaler |
| 12/22/2025 |
Dental/
ENT |
4-356 |
Complete |
ANSI ADA |
Standard No. 32-2024 |
Dentistry - Orthodontic Wires |
| 12/22/2025 |
Dental/
ENT |
4-357 |
Complete |
ANSI ADA |
Standard No. 54-1986 (R2024) |
Double-Pointed, Parenteral, Single Use Needles for Dentistry |
| 12/22/2025 |
Dental/
ENT |
4-358 |
Complete |
ANSI ADA |
Standard No. 95-2020 |
Endodontics Instruments - Enlargers |
| 12/22/2025 |
Dental/
ENT |
4-359 |
Complete |
ANSI ADA |
Standard No. 159-2024 |
Dentistry - Coiled Springs for Use in Orthodontics |
| 12/22/2025 |
Dental/
ENT |
4-360 |
Complete |
ISO |
3630-1 Third edition 2019-08 |
Dentistry - Endodontic instruments - Part 1: General requirements |
| ANSI ADA |
Standard No. 101-2021 |
Endodontic Instruments - General Requirements |
| 12/22/2025 |
Dental/
ENT |
4-361 |
Complete |
ISO |
3630-2 Fourth edition 2023-02 |
Dentistry - Endodontic instruments - Part 2: Enlargers |
| 12/22/2025 |
Dental/
ENT |
4-362 |
Complete |
ISO |
3630-3 Third edition 2021-06 Corrected version 2023-05 |
Dentistry - Endodontic instruments - Part 3: Compactors |
| ANSI ADA |
Standard No. 71-2022 |
Dentistry - Endodontic Instruments: Compactors |
| 12/22/2025 |
Dental/
ENT |
4-363 |
Complete |
ISO |
3630-5 Second edition 2020-08 |
Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments |
| ANSI ADA |
Standard No. 28-2021 |
Endodontic Instruments - Shaping and Cleaning Instruments |
| 12/22/2025 |
Dental/
ENT |
4-364 |
Complete |
ISO |
3990 First edition 2023-07 |
Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials |
| 12/22/2025 |
Dental/
ENT |
4-365 |
Complete |
ISO |
6873 Third edition 2013-04 |
Dentistry - Gypsum products |
| ANSI ADA |
Standards No. 25-2015 (R2021) |
Dental Gypsum Products |
| 12/22/2025 |
Dental/
ENT |
4-366 |
Complete |
ISO |
7551 Second edition 2023-05 |
Dentistry - Endodontic absorbent points |
| ANSI ADA |
Standard No. 73-2024 |
Dentistry - Endodontic Absorbent Points |
| 12/22/2025 |
Dental/
ENT |
4-367 |
Complete |
ISO |
9997 Third edition 2020-01 |
Dentistry - Cartridge Syringes |
| 12/22/2025 |
General I (QS/
RM) |
5-146 |
Complete |
ISO |
80369-6 Second edition 2025-05 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications |
| 12/22/2025 |
General I (QS/
RM) |
5-147 |
Complete |
ISO |
80369-1 Third edition 2025-10 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 12/22/2025 |
General I (QS/
RM) |
5-148 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 [Including AMD1: 2025] |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)] |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-439 |
Partial |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-514 |
Complete |
ISO |
1135-4 Seventh edition 2025-05 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-515 |
Complete |
ASTM |
D6499-24 |
Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-516 |
Partial |
ASTM |
F2407/F2407M-23a |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-517 |
Complete |
ASTM |
F3502-25 |
Standard Specification for Barrier Face Coverings |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-518 |
Complete |
ASTM |
F1670/F1670M-24a |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-519 |
Complete |
ASTM |
F2101-25 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-520 |
Complete |
ASTM |
F3352/F3352M-23b |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 12/22/2025 |
InVitro Diagnostics |
7-346 |
Complete |
CLSI |
EP32 2nd Edition |
Implementation of Metrological Traceability in Laboratory Medicine |
| 12/22/2025 |
InVitro Diagnostics |
7-347 |
Complete |
CLSI |
EP21 3rd Edition |
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| 12/22/2025 |
InVitro Diagnostics |
7-348 |
Complete |
CLSI |
EP37 2nd Edition |
Supplemental Tables for Interference Testing in Clinical Chemistry |
| 12/22/2025 |
InVitro Diagnostics |
7-349 |
Complete |
CLSI |
EP35 2nd Edition |
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| 12/22/2025 |
InVitro Diagnostics |
7-351 |
Complete |
CLSI |
EP46 1st Edition |
Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures |
| 12/22/2025 |
Materials |
8-628 |
Complete |
ASTM |
F754-24 |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| 12/22/2025 |
Materials |
8-629 |
Complete |
ASTM |
F67-24 |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
| 12/22/2025 |
Materials |
8-630 |
Complete |
ASTM |
F90-24 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| 12/22/2025 |
Materials |
8-631 |
Complete |
ASTM |
F1854-25 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Using Digital Images |
| 12/22/2025 |
Materials |
8-632 |
Complete |
ASTM |
F1058-25 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
| 12/22/2025 |
Materials |
8-633 |
Complete |
ASTM |
F2902-24 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 12/22/2025 |
Materials |
8-634 |
Complete |
ASTM |
F2066-23 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 12/22/2025 |
Materials |
8-635 |
Complete |
ASTM |
F75-23 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 12/22/2025 |
Materials |
8-636 |
Complete |
ASTM |
F688-25 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 12/22/2025 |
Materials |
8-637 |
Complete |
ASTM |
F2579-24 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 12/22/2025 |
Materials |
8-638 |
Complete |
ASTM |
F2313-24 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
| 12/22/2025 |
Materials |
8-639 |
Complete |
ASTM |
F1091-25 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/22/2025 |
Materials |
8-640 |
Complete |
ASTM |
F961-25 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/22/2025 |
Materials |
8-641 |
Complete |
ASTM |
F629-24 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 12/22/2025 |
Materials |
8-642 |
Complete |
ASTM |
F2895-24 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/22/2025 |
Materials |
8-643 |
Complete |
ASTM |
F2820-24 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 12/22/2025 |
Materials |
8-644 |
Complete |
ASTM |
F2848-25 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/22/2025 |
Materials |
8-645 |
Complete |
ASTM |
F1925-24 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/22/2025 |
Materials |
8-646 |
Complete |
ASTM |
F624-25 |
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications |
| 12/22/2025 |
Ophthalmic |
10-139 |
Complete |
ISO |
11980 Fourth edition 2025-06 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 12/22/2025 |
Ophthalmic |
10-140 |
Complete |
ANSI |
Z80.1-2020 |
American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations |
| 12/22/2025 |
Ophthalmic |
10-141 |
Complete |
ISO |
11978 Third edition 2017-08 [Including AMD1:2020] |
Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)] |
| 12/22/2025 |
Orthopedic |
11-423 |
Complete |
ASTM |
F2267-24 |
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 12/22/2025 |
Orthopedic |
11-424 |
Complete |
ASTM |
F983-24 |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| 12/22/2025 |
Orthopedic |
11-425 |
Complete |
ASTM |
F565-21 |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 12/22/2025 |
Orthopedic |
11-426 |
Complete |
ASTM |
F2943-25 |
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants |
| 12/22/2025 |
Orthopedic |
11-427 |
Complete |
ASTM |
F1264-24 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-428 |
Complete |
ASTM |
F1541-24 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-429 |
Complete |
ASTM |
F366-24 |
Standard Specification for Fixation Pins and Wires |
| 12/22/2025 |
Orthopedic |
11-430 |
Complete |
ASTM |
F564-24 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 12/22/2025 |
Orthopedic |
11-431 |
Complete |
ASTM |
F384-24 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-432 |
Complete |
ASTM |
F2180-24 |
Standard Specification for Metallic Implantable Strands and Cables |
| 12/22/2025 |
Orthopedic |
11-433 |
Partial |
ASTM |
F2028-25a |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening |
| 12/22/2025 |
Orthopedic |
11-434 |
Complete |
ASTM |
F3018-25 |
Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement |
| 12/22/2025 |
Orthopedic |
11-435 |
Complete |
ASTM |
F3292-25 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 12/22/2025 |
Orthopedic |
11-436 |
Complete |
ISO |
7207-2 Third edition 2025-08 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
| 12/22/2025 |
Orthopedic |
11-437 |
Complete |
ASTM |
F2033-25 |
Standard Specification for Hip Joint Replacement Bearing Surfaces |
| 12/22/2025 |
Orthopedic |
11-438 |
Complete |
ASTM |
F2502-24 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/22/2025 |
Orthopedic |
11-439 |
Complete |
ASTM |
F3437-23 |
Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
| 12/22/2025 |
Orthopedic |
11-440 |
Complete |
ASTM |
F3738-25 |
Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles |
| 12/22/2025 |
Physical Medicine |
16-237 |
Complete |
ASME |
A18.1-2023 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 12/22/2025 |
Physical Medicine |
16-238 |
Complete |
ISO |
11199-1 Second edition 2021-05 |
Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames |
| 12/22/2025 |
Physical Medicine |
16-239 |
Complete |
ISO |
11199-2 Third edition 2021-07 [Including AMD1:2024] |
Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]. |
| 12/22/2025 |
Radiology |
12-384 |
Complete |
ICDM |
IDMS Version 1.3 May 31 2025 |
Information Display Measurements Standard |
| 12/22/2025 |
Radiology |
12-385 |
Complete |
NEMA |
PS 3.1 - 3.20 2025d |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 12/22/2025 |
Software/
Informatics |
13-150 |
Complete |
ISO IEEE |
11073-10472 Second edition 2024-09 |
Health informatics - Device Interoperability - Part 10472: Personal health device communication - Device specialization - Medication monitor |
| IEEE |
Std 11073-10472-2023 |
Health informatics - Device Interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor |
| 12/22/2025 |
Software/
Informatics |
13-151 |
Complete |
ISO IEEE |
11073-10421 Second Edition 2024-08 |
Health informatics - Device Interoperability - Part 10421: Personal health device communication - Device specialization - Peak expiratory flow monitor (peak flow) |
| IEEE |
Std 11073-10421-2023 |
Health Informatics-Device Interoperability - Part 10421: Personal Health Device Communication - Device Specialization - Peak expiratory flow monitor (peak flow) |
| 12/22/2025 |
Software/
Informatics |
13-152 |
Complete |
ISO |
TS 5615:2025 |
Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics |
| 12/22/2025 |
Software/
Informatics |
13-153 |
Complete |
AAMI |
CR515:2025 |
Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices |
| 12/22/2025 |
Software/
Informatics |
13-154 |
Complete |
IEEE |
Std 11073-10429-2022 |
Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry |
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