|
|
|
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)
|
| 07/06/2020 |
Orthopedic |
11-363 |
Complete |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| 07/06/2020 |
Orthopedic |
11-364 |
Complete |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 07/06/2020 |
Orthopedic |
11-365 |
Complete |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| 07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 07/06/2020 |
Orthopedic |
11-367 |
Complete |
ISO |
14243-3 Second edition 2014-11-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 07/06/2020 |
Orthopedic |
11-368 |
Complete |
ASTM |
F3334-19 |
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| 07/06/2020 |
Orthopedic |
11-369 |
Complete |
ASTM |
F3292-19 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 07/06/2020 |
Radiology |
12-325 |
Complete |
NEMA |
Standards Publication XR 25 -2019 |
Computed Tomography Dose Check |
| 07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 (R2023) |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| 07/06/2020 |
Radiology |
12-332 |
Complete |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
| 07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
| 07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
| 07/06/2020 |
Software/
Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
| 07/06/2020 |
Software/
Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 07/06/2020 |
Software/
Informatics |
13-115 |
Complete |
ISO IEC IEEE |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
| 07/06/2020 |
Sterility |
14-539 |
Complete |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| 07/06/2020 |
Sterility |
14-540 |
Complete |
ISO |
11737-2 Third edition 2019-12 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ANSI AAMI ISO |
11737-2:2019 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| 07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
| 07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 07/06/2020 |
Sterility |
14-543 |
Complete |
ISO |
11139 First edition 2018-08 |
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
| 07/06/2020 |
Sterility |
14-544 |
Complete |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
| 07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
| 07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
| 07/06/2020 |
Tissue Engineering |
15-59 |
Complete |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
| 07/06/2020 |
Tissue Engineering |
15-61 |
Complete |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| 07/06/2020 |
Tissue Engineering |
15-62 |
Complete |
ASTM |
F2602-18 |
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
| 07/06/2020 |
Tissue Engineering |
15-63 |
Complete |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| 10/19/2020 |
Software/
Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
| 12/21/2020 |
Anesthesiology |
1-147 |
Complete |
ISO |
26825 Second edition 2020-10 |
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance |
| 12/21/2020 |
Anesthesiology |
1-148 |
Complete |
ISO |
80601-2-69 Second edition 2020-11 |
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
| 12/21/2020 |
Anesthesiology |
1-149 |
Complete |
ISO |
7376 Third edition 2020-08 |
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation |
| 12/21/2020 |
Anesthesiology |
1-150 |
Complete |
ISO |
8836 Fifth edition 2019-12 |
Suction catheters for use in the respiratory tract |
| 12/21/2020 |
Biocompatibility |
2-277 |
Complete |
ASTM |
F813-20 |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| 12/21/2020 |
Biocompatibility |
2-278 |
Complete |
ASTM |
F719-20 e1 |
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation |
| 12/21/2020 |
Biocompatibility |
2-279 |
Complete |
ASTM |
F750-20 |
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
| 12/21/2020 |
Biocompatibility |
2-280 |
Complete |
ASTM |
F1408-20a |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
| 12/21/2020 |
Biocompatibility |
2-281 |
Complete |
ISO |
TS 10993-19 Second edition 2020-03 |
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
| 12/21/2020 |
Biocompatibility |
2-282 |
Complete |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
| 12/21/2020 |
Biocompatibility |
2-283 |
Complete |
ASTM |
F619-20 |
Standard Practice for Extraction of Materials Used in Medical Devices |
| 12/21/2020 |
Biocompatibility |
2-288 |
Partial |
ISO |
10993-15 Second edition 2019-11 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
| 12/21/2020 |
Cardiovascular |
3-169 |
Partial |
IEC |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ANSI AAMI IEC |
60601-2-4:2010/A1:2018 (Consolidated Text) |
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
| 12/21/2020 |
Dental/
ENT |
4-265 |
Complete |
ISO |
10271 Third edition 2020-08 |
Dentistry - Corrosion test methods for metallic materials |
| ANSI ADA |
Standard No. 97-2020 |
Corrosion Test Methods for Metallic Materials |
| 12/21/2020 |
Dental/
ENT |
4-266 |
Complete |
ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| 12/21/2020 |
Dental/
ENT |
4-268 |
Complete |
ISO |
15841 Second edition 2014-08 |
Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| ANSI ADA |
Standard No. 32-2017 |
Orthodontic Wires |
| 12/21/2020 |
Dental/
ENT |
4-269 |
Complete |
ISO |
3964 Third edition 11-2016 |
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| ANSI ADA |
Standard No. 158-2020 |
Coupling Dimensions for Dental Handpiece Connectors |
| 12/21/2020 |
Dental/
ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
| 12/21/2020 |
Dental/
ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
| 12/21/2020 |
Dental/
ENT |
4-272 |
Complete |
ANSI ADA |
Standard No. 63-2013 |
Root Canal Barbed Broaches and Rasps |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)] |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/21/2020 |
General I (QS/
RM) |
5-133 |
Complete |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| 12/21/2020 |
General II (ES/
EMC) |
19-36 |
Partial |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
| 12/21/2020 |
General II (ES/
EMC) |
19-37 |
Complete |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
| 12/21/2020 |
General II (ES/
EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 12/21/2020 |
General II (ES/
EMC) |
19-39 |
Complete |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)] |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-449 |
Partial |
ASTM |
F1169-19 |
Standard Consumer Safety Specification for Full-Size Baby Cribs |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-450 |
Complete |
IEC |
60601-2-50 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 12/21/2020 |
InVitro Diagnostics |
7-300 |
Complete |
CLSI |
MM13 2nd Edition |
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| 12/21/2020 |
InVitro Diagnostics |
7-301 |
Complete |
CLSI |
GP42 7th Edition |
Collection of Capillary Blood Specimens |
| 12/21/2020 |
InVitro Diagnostics |
7-302 |
Complete |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| 12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| 12/21/2020 |
Materials |
8-537 |
Complete |
ASTM |
F620-20 |
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
| 12/21/2020 |
Materials |
8-538 |
Complete |
ASTM |
F2759-19 |
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
| 12/21/2020 |
Materials |
8-539 |
Complete |
ASTM |
F139-19 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
Materials |
8-541 |
Complete |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/21/2020 |
Materials |
8-542 |
Complete |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Materials |
8-543 |
Partial |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
| 12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| 12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 12/21/2020 |
Materials |
8-548 |
Complete |
ISO ASTM |
52915 Third edition 2020-03 |
Specification for additive manufacturing file format (AMF) Version 1.2 |
| 12/21/2020 |
Materials |
8-549 |
Complete |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 12/21/2020 |
Materials |
8-550 |
Complete |
ASTM |
F2181-20 |
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
| 12/21/2020 |
Materials |
8-551 |
Complete |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/21/2020 |
Materials |
8-552 |
Complete |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 12/21/2020 |
Nanotechnology |
18-17 |
Complete |
ISO |
21363 First edition 2020-06 |
Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy |
| 12/21/2020 |
Nanotechnology |
18-18 |
Complete |
ASTM |
E3247-20 |
Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering |
| 12/21/2020 |
Neurology |
17-17 |
Complete |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder Devices |
| 12/21/2020 |
ObGyn/
Gastroenterology/
Urology |
9-130 |
Complete |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 12/21/2020 |
Ophthalmic |
10-120 |
Complete |
ISO |
TR 22979 Second Edition 2017-05 |
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| 12/21/2020 |
Ophthalmic |
10-121 |
Complete |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
| 12/21/2020 |
Orthopedic |
11-330 |
Partial |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 12/21/2020 |
Orthopedic |
11-371 |
Complete |
ASTM |
F2009-20 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/21/2020 |
Orthopedic |
11-374 |
Complete |
ISO |
7207-2 Second edition 2011-07-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)] |
| 12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| 12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
| 12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
| 12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
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