|
|
|
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 |
| 12/22/2025 |
Software/
Informatics |
13-155 |
Complete |
IEEE |
Std 11073-10442-2023 |
Health informatics - Device Interoperability Part 10442: Personal health device communication - Device specialization - Strength fitness equipment |
| 12/22/2025 |
Software/
Informatics |
13-156 |
Complete |
ISO IEEE |
11073-10471 Second Edition 2024-09 |
Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub |
| IEEE |
Std 11073-10471-2023 |
Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub |
| 12/22/2025 |
Sterility |
14-612 |
Complete |
USP-NF |
M16015_02_01 |
<86> Bacterial Endotoxins Test Using Recombinant Reagents |
| 12/22/2025 |
Tissue Engineering |
15-68 |
Complete |
ASTM |
F2212-25 |
Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| 12/22/2025 |
Tissue Engineering |
15-69 |
Complete |
ASTM |
F2944-20 |
Standard Practice for Automated Colony Forming Unit (CFU) Assays - Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture |
| 07/28/2025 |
General II (ES/
EMC) |
19-57 |
Complete |
IEC |
61326-2-6 Edition 4.0 2025-06 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 05/26/2025 |
Anesthesiology |
1-193 |
Complete |
ISO |
18190 Second edition 2025-02 |
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| 05/26/2025 |
Anesthesiology |
1-194 |
Complete |
ISO |
27427 Fourth edition 2023-07 |
Anaesthetic and respiratory equipment - Nebulizing systems and components |
| 05/26/2025 |
Anesthesiology |
1-195 |
Complete |
ISO |
80369-2 First edition 2024-09 |
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications |
| 05/26/2025 |
Anesthesiology |
1-196 |
Complete |
ISO |
80601-2-90 First edition 2021-08 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
| 05/26/2025 |
Biocompatibility |
2-305 |
Complete |
ASTM |
E1262-24 |
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 05/26/2025 |
Biocompatibility |
2-306 |
Complete |
ASTM |
F1439-24 |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 05/26/2025 |
Biocompatibility |
2-307 |
Complete |
ASTM |
F1877-24 |
Standard Practice for Characterization of Particles |
| 05/26/2025 |
Cardiovascular |
3-198 |
Complete |
ISO |
25539-3 Second edition 2024-10 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| 05/26/2025 |
Cardiovascular |
3-199 |
Complete |
ASTM |
F1841-25 |
Standard Practice for Assessment of Hemolysis in Blood Pumps |
| 05/26/2025 |
Cardiovascular |
3-200 |
Complete |
ASTM |
F2477-24 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 05/26/2025 |
Dental/
ENT |
4-339 |
Complete |
ANSI ADA |
Standard No. 119-2023 |
Dentistry-Manual Toothbrushes |
| 05/26/2025 |
Dental/
ENT |
4-340 |
Complete |
ANSI ADA |
Standard No. 46-2016 |
Dental Patient Chair |
| 05/26/2025 |
Dental/
ENT |
4-341 |
Complete |
ANSI ADA |
Standard No. 47-1-2021 |
Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
| 05/26/2025 |
Dental/
ENT |
4-342 |
Complete |
ANSI ADA |
Standard No. 47-2-2021 |
Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems |
| 05/26/2025 |
Dental/
ENT |
4-343 |
Complete |
ANSI ADA |
Standard No. 105-2024 |
Elastomeric Auxiliaries for Use in Orthodontics |
| 05/26/2025 |
Dental/
ENT |
4-344 |
Complete |
ANSI ADA |
Standard No. 186-2024 |
Dentistry - Polymer-based Machinable Blanks |
| 05/26/2025 |
Dental/
ENT |
4-345 |
Complete |
ANSI ADA |
Standard No. 187-2024 |
Dentistry - Dental CAD/CAM Machinable Ceramic Blanks |
| 05/26/2025 |
Dental/
ENT |
4-346 |
Complete |
ISO |
9680 Fourth edition 2021-11 |
Dentistry - Operating lights |
| ANSI ADA |
Standard No. 89-2023 |
Dentistry - Dental Operating Lights |
| 05/26/2025 |
Dental/
ENT |
4-347 |
Complete |
ISO |
22254 First edition 2005-08 |
Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 05/26/2025 |
General I (QS/
RM) |
5-144 |
Complete |
ISO |
80369-20 Second edition 2024-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 05/26/2025 |
General I (QS/
RM) |
5-145 |
Complete |
IEC |
60417:2025 DB |
Graphical symbols for use on equipment |
| 05/26/2025 |
General II (ES/
EMC) |
19-54 |
Complete |
IEC |
60086-5 Edition 5.0 2021-09 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)] |
| 05/26/2025 |
General II (ES/
EMC) |
19-55 |
Complete |
IEC |
62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
| 05/26/2025 |
General II (ES/
EMC) |
19-56 |
Complete |
IEC |
60086-4 Edition 6.0 2025-01 |
Primary batteries - Part 4: Safety of lithium batteries |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-505 |
Complete |
ISO |
21649 Second Edition 2023-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-506 |
Complete |
ISO |
8536-2 Fourth edition 2023-01 |
Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-507 |
Complete |
ISO |
23908 Second Edition 2024-12 |
Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-508 |
Complete |
IEC |
80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-509 |
Complete |
ASTM |
F3186-24 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-510 |
Complete |
IEC |
80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-511 |
Complete |
ISO |
11040-4 Fourth edition 2024-06 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-512 |
Complete |
IEC |
60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-513 |
Partial |
ISO |
14607 Fourth edition 2024-12 |
Non-active surgical implants - Mammary implants - Specific requirements |
| 05/26/2025 |
InVitro Diagnostics |
7-328 |
Partial |
CLSI |
M100 35th Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 05/26/2025 |
InVitro Diagnostics |
7-329 |
Complete |
CLSI |
EP06-EG 2nd Edition |
Developer Validation of Linearity, Establishment Guide |
| 05/26/2025 |
InVitro Diagnostics |
7-330 |
Partial |
CLSI |
M38M51S 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi |
| 05/26/2025 |
InVitro Diagnostics |
7-331 |
Complete |
CLSI |
AUTO02-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-332 |
Complete |
CLSI |
AUTO01-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-333 |
Complete |
CLSI |
AUTO04-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-334 |
Complete |
CLSI |
AUTO05-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-335 |
Complete |
CLSI |
POCT01-A2 |
Point-of-Care Connectivity - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-336 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. |
| 05/26/2025 |
InVitro Diagnostics |
7-337 |
Complete |
CLSI |
AUTO08-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
| 05/26/2025 |
InVitro Diagnostics |
7-338 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| 05/26/2025 |
InVitro Diagnostics |
7-339 |
Complete |
CLSI |
AUTO09-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-340 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition. |
| 05/26/2025 |
InVitro Diagnostics |
7-341 |
Complete |
CLSI |
AUTO03-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-342 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-343 |
Complete |
CLSI |
AUTO07-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-344 |
Complete |
CLSI |
AUTO11-A2 |
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-345 |
Complete |
CLSI |
AUTO13-A2 (Formerly GP19-A2) |
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
| 05/26/2025 |
Neurology |
17-20 |
Complete |
IEC |
60601-2-40 Third edition 2024-12 |
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| 05/26/2025 |
Neurology |
17-21 |
Partial |
ASTM |
F647-22 |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 05/26/2025 |
Neurology |
17-22 |
Complete |
IEC |
60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 05/26/2025 |
ObGyn/
Gastroenterology/
Urology |
9-151 |
Complete |
ASTM |
F1828-22 |
Standard Specification for Ureteral Stents |
| 05/26/2025 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| 05/26/2025 |
Ophthalmic |
10-137 |
Complete |
ISO |
11979-2 Third edition 2024-10 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| 05/26/2025 |
Ophthalmic |
10-138 |
Partial |
ISO |
16971-1 First edition 2024-11 |
Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye |
| 05/26/2025 |
Orthopedic |
11-420 |
Complete |
ASTM |
F2580-24 |
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses |
| 05/26/2025 |
Orthopedic |
11-421 |
Complete |
ASTM |
F2077-24 |
Standard Test Methods for Intervertebral Body Fusion Devices |
| 05/26/2025 |
Orthopedic |
11-422 |
Complete |
ASTM |
F1798-24 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 05/26/2025 |
Radiology |
12-367 |
Complete |
ISO |
13695 Second edition 2024-11 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 05/26/2025 |
Radiology |
12-368 |
Complete |
ISO |
13696 Second edition 2022-06 |
Optics and photonics - Test methods for radiation scattered by optical components |
| 05/26/2025 |
Radiology |
12-369 |
Complete |
ISO |
11146-1 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 05/26/2025 |
Radiology |
12-370 |
Complete |
ISO |
11146-2 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 05/26/2025 |
Radiology |
12-371 |
Complete |
ISO |
14880-2 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 05/26/2025 |
Radiology |
12-372 |
Complete |
ISO |
14880-3 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 05/26/2025 |
Radiology |
12-373 |
Complete |
ISO |
14880-4 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 05/26/2025 |
Radiology |
12-374 |
Complete |
ISO |
24013 Second edition 2023-06 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
| 05/26/2025 |
Radiology |
12-375 |
Complete |
ANSI UL |
122-2019 |
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019] |
| 05/26/2025 |
Radiology |
12-376 |
Complete |
IEC |
61689 Edition 4.0 2022-03 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| 05/26/2025 |
Radiology |
12-377 |
Complete |
IEC |
62127-03 Edition 2.0 2022-12 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-378 |
Complete |
ISO |
12609-1 Second edition 2021-10 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 05/26/2025 |
Radiology |
12-379 |
Complete |
IEC |
62127-2 Edition 2.0 2025-01 |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-380 |
Complete |
IEC |
60601-2-37 Edition 3.0 2024-07 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 05/26/2025 |
Radiology |
12-381 |
Complete |
IEC |
60601-2-68 Edition 2.0 2025-02 |
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 |
| 05/26/2025 |
Radiology |
12-382 |
Complete |
NEMA |
NU 2-2024 |
Performance Measurements of Positron Emission Tomographs |
| 05/26/2025 |
Radiology |
12-383 |
Complete |
NEMA |
NU 1-2023 |
Performance Measurements of Gamma Cameras |
| 05/26/2025 |
Software/
Informatics |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 05/26/2025 |
Software/
Informatics |
13-142 |
Complete |
FIRST |
CVSS v3.1 |
Common Vulnerability Scoring System version 3.1 |
| 05/26/2025 |
Software/
Informatics |
13-143 |
Complete |
AAMI |
TIR45:2023 |
Guidance on the use of AGILE practices in the development of medical device software |
| 05/26/2025 |
Software/
Informatics |
13-144 |
Complete |
ISO IEEE |
11073-10425 Edition 3, 2024-09 |
Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM) |
| IEEE |
Std 11073-10425-2023 |
Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM) |
| 05/26/2025 |
Software/
Informatics |
13-145 |
Complete |
IEEE |
Std 11073-10419:2023 |
Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump |
| 05/26/2025 |
Software/
Informatics |
13-146 |
Complete |
IEEE |
11073-10103 Second edition 2023 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| 05/26/2025 |
Software/
Informatics |
13-147 |
Complete |
IEEE |
Std 11073-10406-2023 |
Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 05/26/2025 |
Software/
Informatics |
13-148 |
Complete |
IEEE |
Std 11073-10417-2023 |
Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter |
| 05/26/2025 |
Sterility |
14-610 |
Complete |
ISO |
11138-7 First edition 2019-03 |
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results |
| 05/26/2025 |
Sterility |
14-611 |
Complete |
ISO |
11137-1 Second edition 2025-04 |
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 12/23/2024 |
Anesthesiology |
1-182 |
Complete |
ISO |
5362 Fifth edition 2024-07 |
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags |
| 12/23/2024 |
Anesthesiology |
1-183 |
Complete |
ASTM |
G175-24 |
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| 12/23/2024 |
Anesthesiology |
1-184 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 [Including AMD1:2023] |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)]. |
| 12/23/2024 |
Anesthesiology |
1-185 |
Complete |
ISO |
80601-2-79 Second edition 2024-08 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 12/23/2024 |
Anesthesiology |
1-186 |
Complete |
ISO |
80601-2-80 Second edition 2024-08 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
| 12/23/2024 |
Anesthesiology |
1-187 |
Complete |
ISO |
80601-2-12 Third edition 2023-11 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 12/23/2024 |
Anesthesiology |
1-188 |
Complete |
ISO |
80601-2-84 Second edition 2023-11 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 12/23/2024 |
Anesthesiology |
1-189 |
Complete |
ISO |
4135 Fourth edition 2022-01 |
Anaesthetic and respiratory equipment - Vocabulary |
| 12/23/2024 |
Anesthesiology |
1-190 |
Complete |
ISO |
9360-1 First edition 2000-03 |
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| 12/23/2024 |
Anesthesiology |
1-191 |
Complete |
ISO |
9360-2 First edition 2001-07 |
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml |
| 12/23/2024 |
Anesthesiology |
1-192 |
Complete |
ISO |
23371 First edition 2022-05 |
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices |
| 12/23/2024 |
Biocompatibility |
2-304 |
Partial |
ASTM |
F2382-24 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 12/23/2024 |
Cardiovascular |
3-193 |
Complete |
ISO |
12417-1 Second edition 2024-02 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 12/23/2024 |
Cardiovascular |
3-194 |
Complete |
ISO |
7199 Fourth edition 2024-09 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| 12/23/2024 |
Cardiovascular |
3-195 |
Partial |
ISO |
5910 Second edition 2024-07 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 12/23/2024 |
Cardiovascular |
3-196 |
Partial |
ISO |
81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)] |
| 12/23/2024 |
Cardiovascular |
3-197 |
Complete |
ISO |
25539-4 First edition 2021-11 |
Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices |
| 12/23/2024 |
Dental/
ENT |
4-328 |
Complete |
ANSI ADA |
Standard No. 57-2021 |
Endodontic Sealing Materials |
| 12/23/2024 |
Dental/
ENT |
4-329 |
Complete |
ISO |
6872 Fifth edition 2024-08 |
Dentistry - Ceramic materials |
| 12/23/2024 |
Dental/
ENT |
4-330 |
Complete |
ANSI ADA |
Standard No. 63-2020 |
Endodontic Instruments - Auxillary |
| 12/23/2024 |
Dental/
ENT |
4-331 |
Complete |
ISO |
28399 Third edition 2021-03 |
Dentistry - External tooth bleaching products |
| ANSI ADA |
Standard No. 136-2022 |
Dentistry - External Tooth Bleaching Products |
| 12/23/2024 |
Dental/
ENT |
4-332 |
Complete |
ANSI ADA |
Standard No. 206-2024 |
Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
| 12/23/2024 |
Dental/
ENT |
4-333 |
Complete |
ISO |
3630-4 Second edition 2023-08 |
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
| 12/23/2024 |
Dental/
ENT |
4-334 |
Complete |
ISO |
11143 Second edition 2008-07 |
Dentistry - Amalgam separators |
| ANSI ADA |
Standard No. 108-2009, Addendum (R2022) |
Amalgam Separators |
| 12/23/2024 |
Dental/
ENT |
4-335 |
Complete |
ISO |
11499 Third edition 2014-06 |
Dentistry - Single-use cartridges for local anaesthetics |
| ANSI ADA |
Standard No. 190-2020 |
Single-Use Dental Cartridges for Local Anesthetics |
| 12/23/2024 |
Dental/
ENT |
4-336 |
Complete |
ISO |
18397 First edition 2016-01 |
Dentistry - Powered scaler |
| ANSI ADA |
Standard No. 157-2020 |
Powered Dental Scaler Handpieces and Tips |
| 12/23/2024 |
Dental/
ENT |
4-337 |
Complete |
ISO |
20608 First edition 2018-04 |
Dentistry - Powder jet handpieces and powders |
| 12/23/2024 |
Dental/
ENT |
4-338 |
Complete |
ISO |
22683 First edition 2022-05 |
Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems |
| 12/23/2024 |
General I (QS/
RM) |
5-143 |
Complete |
ISO |
14630 Fffth edition 2024-09 |
Non-active surgical implants -- General requirements |
| 12/23/2024 |
General II (ES/
EMC) |
19-51 |
Complete |
UL |
1642 Sixth Edition September 29, 2020 |
Standard For Safety Lithium Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-52 |
Complete |
UL |
2054 Third Edition November 17, 2021 |
Standard For Safety Household and Commercial Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-53 |
Complete |
IEC |
TS 60601-4-6 Edition 1.0 2024-04 |
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-503 |
Complete |
ISO |
16571 Second edition 2024-03 |
Systems for evacuation of plume generated by medical device |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-504 |
Complete |
ASTM |
F1862/F1862M-24 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 12/23/2024 |
InVitro Diagnostics |
7-322 |
Complete |
CLSI |
M47 2nd Edition |
Principles and Procedures for Blood Cultures |
| 12/23/2024 |
InVitro Diagnostics |
7-323 |
Complete |
CLSI |
EP19 3rd Edition |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
| 12/23/2024 |
InVitro Diagnostics |
7-324 |
Complete |
CLSI |
M07 12th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| 12/23/2024 |
InVitro Diagnostics |
7-325 |
Partial |
CLSI |
M02 14th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
| 12/23/2024 |
InVitro Diagnostics |
7-326 |
Partial |
CLSI |
M24S 2nd Edition |
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes |
| 12/23/2024 |
InVitro Diagnostics |
7-327 |
Partial |
CLSI |
M100 34th Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 12/23/2024 |
Materials |
8-618 |
Complete |
ASTM |
F1350-24 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
| 12/23/2024 |
Materials |
8-619 |
Complete |
ISO |
5832-4 Fourth edition 2024-04 |
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy |
| 12/23/2024 |
Materials |
8-620 |
Complete |
ISO |
5832-11 Third edition 2024-03 |
Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 12/23/2024 |
Materials |
8-621 |
Complete |
ISO |
5832-1 Sixth edition 2024-04 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| 12/23/2024 |
Materials |
8-622 |
Complete |
ASTM |
F2004-24 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
| 12/23/2024 |
Materials |
8-623 |
Complete |
ASTM |
F1314-24 |
Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
| 12/23/2024 |
Materials |
8-624 |
Complete |
ASTM |
F2129-24 |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| 12/23/2024 |
Materials |
8-625 |
Complete |
ASTM |
F1295-24 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 12/23/2024 |
Materials |
8-626 |
Complete |
ASTM |
E2948-24 |
Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire |
| 12/23/2024 |
Materials |
8-627 |
Complete |
ASTM |
F3604-23 |
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion. |
| 12/23/2024 |
Orthopedic |
11-410 |
Complete |
ASTM |
F3161-24 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 12/23/2024 |
Orthopedic |
11-411 |
Complete |
ASTM |
F1611-20 (Reapproved 2024) |
Standard Specification for Intramedullary Reamers |
| 12/23/2024 |
Orthopedic |
11-412 |
Complete |
ASTM |
F3129-24 |
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
| 12/23/2024 |
Orthopedic |
11-413 |
Complete |
ASTM |
F543-23 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
| 12/23/2024 |
Orthopedic |
11-414 |
Complete |
ASTM |
F382-24 |
Standard Specification and Test Method for Metallic Bone Plates |
| 12/23/2024 |
Orthopedic |
11-415 |
Complete |
ASTM |
F2554-22 |
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems |
| 12/23/2024 |
Orthopedic |
11-416 |
Complete |
ASTM |
F2996-24 |
Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 12/23/2024 |
Orthopedic |
11-417 |
Complete |
ASTM |
F3090-24 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements |
| 12/23/2024 |
Orthopedic |
11-418 |
Complete |
ASTM |
F3631-24 |
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
|
| 12/23/2024 |
Orthopedic |
11-419 |
Complete |
ASTM |
F3690-24 |
Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance |
| 12/23/2024 |
Radiology |
12-362 |
Complete |
IEC |
61674 Edition 3.0 2024-07 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 12/23/2024 |
Radiology |
12-363 |
Complete |
NEMA |
PS 3.1 - 3.20 2024e |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 12/23/2024 |
Radiology |
12-364 |
Complete |
IEC |
61223-3-8 Edition 1.0 2024-03 |
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
|
| 12/23/2024 |
Radiology |
12-365 |
Complete |
IEC |
60627 Edition 3.0 2013-07 |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| 12/23/2024 |
Radiology |
12-366 |
Complete |
IEC |
61223-3-6 Edition 1.0 2020-02 |
Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation |
| 12/23/2024 |
Software/
Informatics |
13-141 |
Complete |
ISO IEEE |
11073-10701 First Edition, 2024-09 |
Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System |
| IEEE |
Std 11073-10701-2022 |
Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system |
| 12/23/2024 |
Sterility |
14-606 |
Complete |
ANSI AAMI |
ST24:2024 |
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
|
| 12/23/2024 |
Sterility |
14-607 |
Complete |
ANSI AAMI |
ST58:2024 |
Chemical sterilization and high-level disinfection in health care facilities |
| 12/23/2024 |
Sterility |
14-608 |
Complete |
AAMI |
TIR106:2024 |
Microbiological methods - Understanding and use of product bioburden data |
| 12/23/2024 |
Sterility |
14-609 |
Complete |
AAMI |
TIR17:2024 |
Compatibility of materials subjected to sterilization |
| 10/07/2024 |
Anesthesiology |
1-180 |
Complete |
NFPA |
99:2024 |
Health Care Facilities Code |
| 10/07/2024 |
Anesthesiology |
1-181 |
Complete |
ASME |
PVHO-1-2023 |
Safety Standard for Pressure Vessels for Human Occupancy |
| 09/09/2024 |
Sterility |
14-460 |
Complete |
ISO |
11140-1 Third edition 2014-11-01 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
| ANSI AAMI ISO |
11140-1:2014 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
| 09/09/2024 |
Sterility |
14-604 |
Complete |
ISO |
11737-3 First Edition 2023-06 |
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing |
| 09/09/2024 |
Sterility |
14-605 |
Complete |
ISO |
13004 First edition 2022-10 |
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD |
| ANSI AAMI ISO |
13004:2022 |
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD |
| 05/29/2024 |
Anesthesiology |
1-167 |
Complete |
CGA |
V-5:2019 |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
| 05/29/2024 |
Anesthesiology |
1-168 |
Complete |
CGA |
V-7.1:2021 |
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases |
| 05/29/2024 |
Anesthesiology |
1-169 |
Complete |
CGA |
V-1:2021 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
| 05/29/2024 |
Anesthesiology |
1-170 |
Complete |
CGA |
C-9:2019 |
Standard Color Marking of Compressed Gas Containers for Medical Use |
| 05/29/2024 |
Anesthesiology |
1-171 |
Complete |
ISO |
5367 Sixth edition 2023-07 |
Anaesthetic and respiratory equipment - Breathing sets and connectors |
| 05/29/2024 |
Anesthesiology |
1-172 |
Complete |
ISO |
11712 Second edition 2023-11 |
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| 05/29/2024 |
Anesthesiology |
1-173 |
Partial |
ISO |
18562-1 Second edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| 05/29/2024 |
Anesthesiology |
1-174 |
Complete |
ISO |
18562-2 Second edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
| 05/29/2024 |
Anesthesiology |
1-175 |
Complete |
ISO |
18562-3 Second Edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
| 05/29/2024 |
Anesthesiology |
1-176 |
Complete |
ISO |
18562-4 Second Edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| 05/29/2024 |
Anesthesiology |
1-177 |
Complete |
ISO |
80601-2-74 Second edition 2021-07 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 05/29/2024 |
Anesthesiology |
1-178 |
Complete |
ISO |
23747 Second edition 2015-08 |
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| 05/29/2024 |
Anesthesiology |
1-179 |
Partial |
ISO |
26782 First edition 2009-07 |
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] |
| 05/29/2024 |
Cardiovascular |
3-191 |
Complete |
ISO |
18242 First edition 2016-09-01 [Including AMD1:2023] |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)] |
| 05/29/2024 |
Cardiovascular |
3-192 |
Complete |
ISO |
22679 First edition 2021-11 |
Cardiovascular implants - Transcatheter cardiac occluders
|
| 05/29/2024 |
Dental/
ENT |
4-325 |
Complete |
ANSI ADA |
Standard No. 96-2020 |
Dental Water-based Cements |
| 05/29/2024 |
Dental/
ENT |
4-326 |
Complete |
ISO |
9687 Second edition 2015-02 |
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
| 05/29/2024 |
Dental/
ENT |
4-327 |
Complete |
ISO |
21531 First edition 2009-02 |
Dentistry - Graphical symbols for dental instruments |
| 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 |
| 05/29/2024 |
General II (ES/
EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-498 |
Complete |
ISO |
10555-4 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-499 |
Complete |
ISO |
10555-1 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-500 |
Complete |
IEC |
63045 Edition 1.0 2020-05 |
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-501 |
Complete |
ISO |
15747 Third edition 2018-09 |
Plastic containers for intravenous injections |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-502 |
Complete |
ISO |
23217 First Edition 2024-02 |
Injection systems for self-administration by paediatric patients - Requirements and guidelines for design |
| 05/29/2024 |
InVitro Diagnostics |
7-321 |
Partial |
CLSI |
MM24 1st Edition |
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
| 05/29/2024 |
Materials |
8-611 |
Complete |
ISO |
9584 Second edition 2023-10 |
Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants |
| 05/29/2024 |
Materials |
8-612 |
Complete |
ASTM |
F899-23 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| 05/29/2024 |
Materials |
8-613 |
Complete |
ASTM |
F2527-24 |
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants |
| 05/29/2024 |
Materials |
8-614 |
Complete |
ASTM |
F3456-22 |
Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials |
| 05/29/2024 |
Materials |
8-615 |
Complete |
ISO ASTM |
52926-1 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators |
| 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) |
| 05/29/2023 |
Cardiovascular |
3-188 |
Partial |
ISO |
81060-3 First edition 2022-12 |
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
| 05/29/2023 |
Dental/
ENT |
4-298 |
Complete |
ISO |
4049 Fifth edition 2019-05 |
Dentistry - Polymer-based restorative materials |
| ANSI ADA |
Standard No. 27-2022 |
Polymer-based Restorative Materials |
| 05/29/2023 |
Dental/
ENT |
4-299 |
Complete |
ISO |
3107 Fifth edition 2022-09 |
Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements |
| ANSI ADA |
Standard No. 30-2023 |
Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements |
| 05/29/2023 |
Dental/
ENT |
4-300 |
Complete |
ISO |
22674 Third edition 2022-08 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA |
Standard No. 134-2023 |
Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances |
| 05/29/2023 |
Dental/
ENT |
4-301 |
Complete |
ISO |
21563 Second edition 2021-08 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2022 |
Hydrocolloid Impression Materials |
| 05/29/2023 |
Dental/
ENT |
4-302 |
Complete |
ISO |
10477 Fourth edition 2020-10 |
Dentistry - Polymer-based crown and veneering materials |
| ANSI ADA |
Standard No. 53-2022 |
Polymer-Based Crown and Veneering Materials |
| 05/29/2023 |
Dental/
ENT |
4-303 |
Complete |
ISO |
9333 Third edition 2022-08 |
Dentistry - Brazing materials |
| 05/29/2023 |
Dental/
ENT |
4-304 |
Complete |
ISO |
21606 Second edition 2022-08 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 05/29/2023 |
Dental/
ENT |
4-305 |
Partial |
ISO |
10637 Second edition 2018-05 |
Dentistry - Central suction source equipment |
| ANSI ADA |
Standard No. 177-2020 |
Central Suction Source Equipment |
| 05/29/2023 |
Dental/
ENT |
4-306 |
Partial |
ISO |
22052 First edition 2020-06 |
Dentistry - Compressed air source equipment |
| ANSI ADA |
Standard No. 94-2021 |
Central Compressed Air Source Equipment |
| 05/29/2023 |
Dental/
ENT |
4-307 |
Complete |
ISO |
13504 First edition 2012-07 |
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
| 05/29/2023 |
Dental/
ENT |
4-308 |
Complete |
ISO |
14708-7 Second edition 2019-12 |
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-486 |
Complete |
ISO |
10535 Third edition 2021-10 |
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-487 |
Partial |
ANSI AAMI |
PB70:2022 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-488 |
Complete |
ASTM |
F1671/F1671M-22 |
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 |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-489 |
Complete |
IEC |
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
|
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-490 |
Complete |
ISO |
10555-6 First edition 2015-04-15 [Including AMD1:2019] |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-491 |
Complete |
ASTM |
F1670/F1670M-17a |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-492 |
Complete |
ASTM |
F2100-23 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-493 |
Complete |
ASTM |
F2101-23 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-495 |
Complete |
ISO |
20698 First Edition 2018-07 |
Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-496 |
Partial |
ASTM |
F739-20 |
Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |
| 05/29/2023 |
InVitro Diagnostics |
7-315 |
Complete |
CLSI |
EP12 3rd Edition |
Evaluation of Qualitative, Binary Output Examination Performance |
| 05/29/2023 |
InVitro Diagnostics |
7-316 |
Complete |
CLSI |
NBS01 7th Edition |
Dried Blood Spot Specimen Collection for Newborn Screening |
| 05/29/2023 |
InVitro Diagnostics |
7-317 |
Partial |
CLSI |
M100 33rd, Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 05/29/2023 |
Materials |
8-599 |
Complete |
ASTM |
F1295-22 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 05/29/2023 |
Materials |
8-600 |
Complete |
ASTM |
F1978-22 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
| 05/29/2023 |
Materials |
8-601 |
Complete |
ASTM |
F2516-22 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
| 05/29/2023 |
Materials |
8-602 |
Complete |
ASTM |
F2503-23 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 05/29/2023 |
Materials |
8-603 |
Complete |
ASTM |
F1472-23 |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 05/29/2023 |
Materials |
8-604 |
Complete |
ASTM |
F2257-22 |
Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673) |
| 05/29/2023 |
Nanotechnology |
18-23 |
Complete |
ASTM |
E3025-22 |
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-145 |
Complete |
ASTM |
D7661-18 |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-146 |
Complete |
ISO |
8600-4 Third Edition 2023-01 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-148 |
Complete |
ISO CIE |
11664-6 Second edition 2022-08 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-149 |
Complete |
IEC |
60601-2-39 Edition 3.0 2018-04 |
Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
|
| 05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
| 05/29/2023 |
Physical Medicine |
16-234 |
Complete |
ISO |
7176-14 Third Edition 2022 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
| 05/29/2023 |
Physical Medicine |
16-235 |
Complete |
ISO |
7176-25 Second Edition 2022 |
Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
| 05/29/2023 |
Physical Medicine |
16-236 |
Complete |
ISO |
7176-19 Third Edition 2022 |
Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles |
| 05/29/2023 |
Radiology |
12-347 |
Complete |
IEC |
60601-2-33 Edition 4.0 2022-08 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| 05/29/2023 |
Radiology |
12-350 |
Complete |
IEC |
60806 Edition 2.0 2022-11 |
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
| 05/29/2023 |
Radiology |
12-351 |
Complete |
IEC |
60601-2-43 Edition 3.0 2022-12 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
| 05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
| 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 |
| 05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| 05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
| 04/03/2023 |
General II (ES/
EMC) |
19-34 |
Complete |
IEC |
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section |
| 04/03/2023 |
General II (ES/
EMC) |
19-49 |
Complete |
IEC |
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
| 02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 12/19/2022 |
Anesthesiology |
1-153 |
Complete |
NFPA |
99:2021 |
Health Care Facilities Code |
| 12/19/2022 |
Anesthesiology |
1-154 |
Complete |
ASME |
PVHO-1-2019 |
Safety Standard for Pressure Vessels for Human Occupancy |
| 12/19/2022 |
Anesthesiology |
1-155 |
Complete |
ISO |
10079-2 Fourth edition 2022-03 |
Medical suction equipment - Part 2: Manually powered suction equipment |
| 12/19/2022 |
Anesthesiology |
1-156 |
Complete |
ISO |
10079-3 Fourth edition 2022-03 |
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| 12/19/2022 |
Anesthesiology |
1-157 |
Complete |
ISO |
10079-1 Fourth edition 2022-03 |
Medical suction equipment - Part 1: Electrically powered suction equipment |
| 12/19/2022 |
Anesthesiology |
1-158 |
Complete |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
| 12/19/2022 |
Anesthesiology |
1-159 |
Complete |
ISO |
18778 Second edition 2022-06 |
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors |
| 12/19/2022 |
Anesthesiology |
1-160 |
Complete |
ISO |
80601-2-84 First edition 2020-07 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 12/19/2022 |
Biocompatibility |
2-289 |
Complete |
ISO |
10993-12 Fifth edition 2021-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| 12/19/2022 |
Biocompatibility |
2-296 |
Partial |
ISO |
10993-10 Fourth edition 2021-11 |
Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| 12/19/2022 |
Biocompatibility |
2-297 |
Complete |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| 12/19/2022 |
Biocompatibility |
2-298 |
Partial |
ISO |
10993-18 Second edition 2020-01 Amendment 1 2022-05 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]. |
| 12/19/2022 |
Cardiovascular |
3-183 |
Complete |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 12/19/2022 |
Dental/
ENT |
4-294 |
Complete |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
| 12/19/2022 |
Dental/
ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 12/19/2022 |
Dental/
ENT |
4-296 |
Complete |
ISO |
9873 Fourth edition 2019-03 |
Dentistry - Intra-oral mirrors |
| ANSI ADA |
Standard No. 191-2020 |
Intra-Oral Mirrors |
| 12/19/2022 |
Dental/
ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
| 12/19/2022 |
General I (QS/
RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
| 12/19/2022 |
General I (QS/
RM) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
| 12/19/2022 |
General I (QS/
RM) |
5-138 |
Complete |
AAMI |
TIR66: 2017/(R)2025 |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 12/19/2022 |
General I (QS/
RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 12/19/2022 |
General I (QS/
RM) |
5-141 |
Complete |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 12/19/2022 |
General II (ES/
EMC) |
19-48 |
Complete |
IEEE ANSI |
USEMCSC C63.27-2021 |
American National Standard for Evaluation of Wireless Coexistence |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-483 |
Complete |
IEC |
60601-2-35 Edition 2.0 2020-09 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-485 |
Complete |
ISO |
7886-4 Second Edition 2018-11 |
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| 12/19/2022 |
InVitro Diagnostics |
7-313 |
Complete |
CLSI |
EP27 2nd Edition |
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| 12/19/2022 |
InVitro Diagnostics |
7-314 |
Partial |
CLSI |
M27M44S, 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| 12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
| 12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 12/19/2022 |
Nanotechnology |
18-21 |
Complete |
ISO |
TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
| 12/19/2022 |
Nanotechnology |
18-22 |
Complete |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-140 |
Partial |
ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-142 |
Complete |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
| 12/19/2022 |
Ophthalmic |
10-132 |
Partial |
ISO |
10942 Third edition 2022-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
| 12/19/2022 |
Ophthalmic |
10-133 |
Complete |
ISO |
11979-10 Second edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
| 12/19/2022 |
Orthopedic |
11-394 |
Complete |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| 12/19/2022 |
Orthopedic |
11-395 |
Complete |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| 12/19/2022 |
Orthopedic |
11-396 |
Complete |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
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