|
|
|
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)
|
| 12/23/2024 |
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 |
ADA ANSI |
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 |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 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 |
11073-10701-2022 |
IEEE Standard for 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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. 78-2021 |
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 |
12-352 |
Complete |
NEMA |
PS 3.1 - 3.20 2023e |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 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)2020 |
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)] |
| 12/19/2022 |
Orthopedic |
11-397 |
Complete |
ASTM |
F3210-22e1 |
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
| 12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
| 12/19/2022 |
Physical Medicine |
16-233 |
Complete |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
| 12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 12/19/2022 |
Software/
Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
| 12/19/2022 |
Software/
Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
| 12/19/2022 |
Software/
Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| 12/19/2022 |
Software/
Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
| 12/19/2022 |
Software/
Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
| 12/19/2022 |
Software/
Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
| 12/19/2022 |
Software/
Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
| 12/19/2022 |
Software/
Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| 12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
| 12/19/2022 |
Sterility |
14-581 |
Complete |
ASTM |
F2638-22 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
| 12/19/2022 |
Sterility |
14-582 |
Complete |
AAMI ISO |
TIR11137-4:2022 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
| ISO |
TS 11137-4 First edition 2020-06 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
| 12/19/2022 |
Sterility |
14-583 |
Complete |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| 05/30/2022 |
Anesthesiology |
1-152 |
Complete |
ISO |
80601-2-87 First edition 2021-04 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
| 05/30/2022 |
Cardiovascular |
3-181 |
Complete |
ISO |
25539-2 Third edition 2020-09 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| 05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 05/30/2022 |
Dental/
ENT |
4-293 |
Complete |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 05/30/2022 |
General II (ES/
EMC) |
19-46 |
Complete |
ANSI AAMI |
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] |
| 05/30/2022 |
General II (ES/
EMC) |
19-47 |
Complete |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)] |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-475 |
Complete |
ISO |
11608-4:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-476 |
Complete |
ISO |
11608-2:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-477 |
Complete |
ISO |
11608-3:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-478 |
Complete |
ISO |
11608-1:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-479 |
Complete |
ISO |
11608-5:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-480 |
Complete |
ISO |
11608-6:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-481 |
Complete |
ANSI AAMI |
CN27:2021 |
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-482 |
Complete |
AAMI |
TIR101:2021 |
Fluid delivery performance testing for infusion pumps |
| 05/30/2022 |
InVitro Diagnostics |
7-312 |
Complete |
CLSI |
M39 5th Edition |
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| 05/30/2022 |
Materials |
8-583 |
Complete |
ASTM |
F562-22 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| 05/30/2022 |
Materials |
8-584 |
Complete |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 05/30/2022 |
Materials |
8-585 |
Complete |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| 05/30/2022 |
Materials |
8-586 |
Complete |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 05/30/2022 |
Materials |
8-587 |
Complete |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 05/30/2022 |
Materials |
8-588 |
Complete |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 05/30/2022 |
Materials |
8-591 |
Complete |
ASTM |
F2229-21 |
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) |
| 05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-593 |
Complete |
ISO |
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
Implants for surgery - Hydroxyapatite - Part 6: Powders |
| 05/30/2022 |
ObGyn/
Gastroenterology/
Urology |
9-139 |
Complete |
CIE ISO |
11664-5:2016 |
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
| 05/30/2022 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
| 05/30/2022 |
Physical Medicine |
16-166 |
Partial |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 05/30/2022 |
Radiology |
12-343 |
Complete |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| 05/30/2022 |
Radiology |
12-344 |
Complete |
IEC |
62563-2 Edition 1.0 2021-11 |
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
| 05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| 05/30/2022 |
Sterility |
14-572 |
Partial |
ANSI AAMI |
ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
| 05/30/2022 |
Sterility |
14-573 |
Complete |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 05/30/2022 |
Sterility |
14-576 |
Complete |
ASTM |
D4169-22 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
| 05/30/2022 |
Sterility |
14-577 |
Complete |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
| 05/30/2022 |
Sterility |
14-578 |
Partial |
ISO |
17664-1 First edition 2021-07 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| 05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
| 02/07/2022 |
General II (ES/
EMC) |
19-45 |
Complete |
AIM |
Standard 7351731 Rev. 3.00 2021-06-04 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
| 12/20/2021 |
Biocompatibility |
2-292 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
| 12/20/2021 |
Biocompatibility |
2-293 |
Complete |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Elution Test |
| 12/20/2021 |
Biocompatibility |
2-294 |
Partial |
USP-NF |
M98834_01_01 |
<88> Biological Reactivity Tests, In Vivo |
| 12/20/2021 |
Biocompatibility |
2-295 |
Partial |
USP-NF |
M98900_01_01 |
<151> Pyrogen Test (USP Rabbit Test) |
| 12/20/2021 |
Cardiovascular |
3-171 |
Complete |
ASTM |
F2514-21 |
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 12/20/2021 |
Cardiovascular |
3-173 |
Complete |
ISO |
5840-3 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 12/20/2021 |
Cardiovascular |
3-174 |
Partial |
ISO |
5840-1 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 12/20/2021 |
Cardiovascular |
3-175 |
Complete |
ISO |
5840-2 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
| 12/20/2021 |
Cardiovascular |
3-176 |
Complete |
ISO |
18193 First edition 2021-08 |
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
| 12/20/2021 |
Cardiovascular |
3-177 |
Complete |
ASTM |
F2606-08 (Reapproved 2021) |
Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
| 12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| 12/20/2021 |
Cardiovascular |
3-179 |
Complete |
ASTM |
F3172-15 (Reapproved 2021) |
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| 12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
| 12/20/2021 |
Dental/
ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
| 12/20/2021 |
Dental/
ENT |
4-285 |
Complete |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
| 12/20/2021 |
Dental/
ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
| 12/20/2021 |
Dental/
ENT |
4-287 |
Complete |
ANSI ADA |
Standard No. 116-2020 |
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
| 12/20/2021 |
Dental/
ENT |
4-288 |
Complete |
ISO |
7488 Second edition 2018-04 |
Dentistry - Mixing machines for dental amalgam |
| ANSI ADA |
Standard No. 43-2020 |
Electrically Powered Dental Amalgamators |
| 12/20/2021 |
Dental/
ENT |
4-289 |
Complete |
ISO |
18556 Frist edition 2016-04 |
Dentistry - Intraoral spatulas |
| 12/20/2021 |
Dental/
ENT |
4-290 |
Complete |
ISO |
28158 Second edition 2018-09 |
Dentistry - Integrated dental floss and handles |
| ANSI ADA |
Standard No. 185-2020 |
Integrated Dental Floss and Handles |
| 12/20/2021 |
Dental/
ENT |
4-291 |
Complete |
ISO |
28399 First edition 2011-01 |
Dentistry - Products for external tooth bleaching |
| ANSI ADA |
Standard No. 136-2015 (R2020) |
Products for External Tooth Bleaching |
| 12/20/2021 |
Dental/
ENT |
4-292 |
Complete |
ISO |
28888 First edition 2013-10 |
Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues |
| ANSI ADA |
Standard No. 151-2015 (R2020) |
Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues |
| 12/20/2021 |
General I (QS/
RM) |
5-134 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 12/20/2021 |
General II (ES/
EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
| 12/20/2021 |
General II (ES/
EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
| 12/20/2021 |
General II (ES/
EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 12/20/2021 |
General II (ES/
EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-464 |
Complete |
ISO |
11040-4 Third edition 2015-04-01 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-466 |
Complete |
USP-NF |
M76070_03_01 |
Sodium Chloride Injection |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-474 |
Partial |
ASTM |
F3352-19 |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 12/20/2021 |
InVitro Diagnostics |
7-309 |
Complete |
ISO |
17099 First edition 2014-11-15 |
Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
| 12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/20/2021 |
Materials |
8-565 |
Complete |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
| 12/20/2021 |
Materials |
8-566 |
Complete |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
| 12/20/2021 |
Materials |
8-567 |
Complete |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
| 12/20/2021 |
Materials |
8-568 |
Complete |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
| 12/20/2021 |
Materials |
8-569 |
Complete |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 12/20/2021 |
Materials |
8-570 |
Complete |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 12/20/2021 |
Materials |
8-571 |
Complete |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 12/20/2021 |
Materials |
8-572 |
Complete |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-573 |
Complete |
ASTM |
F2695-12(2020) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-575 |
Complete |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| 12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
| 12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| 12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
| 12/20/2021 |
Nanotechnology |
18-19 |
Complete |
ISO |
19749 First edition 2021-07 |
Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy |
| 12/20/2021 |
Nanotechnology |
18-20 |
Complete |
ASTM |
E3275-21 |
Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis |
| 12/20/2021 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 12/20/2021 |
Ophthalmic |
10-129 |
Complete |
ASTM |
D790-17 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| 12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
| 12/20/2021 |
Orthopedic |
11-385 |
Complete |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| 12/20/2021 |
Orthopedic |
11-386 |
Complete |
ASTM |
F2665-21 |
Standard Specification for Total Ankle Replacement Prosthesis |
| 12/20/2021 |
Orthopedic |
11-387 |
Complete |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| 12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| 12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
| 12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| 12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| 12/20/2021 |
Orthopedic |
11-393 |
Complete |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
| 12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 12/20/2021 |
Radiology |
12-341 |
Complete |
IEC |
62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION |
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
| 12/20/2021 |
Software/
Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| 12/20/2021 |
Sterility |
14-563 |
Complete |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
| 12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
| 12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
| 12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
| 12/20/2021 |
Sterility |
14-567 |
Complete |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
| 12/20/2021 |
Sterility |
14-568 |
Complete |
USP-NF |
M98800_01_01 |
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
| 12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
| 12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
| 12/20/2021 |
Sterility |
14-571 |
Complete |
ISO |
11138-8 First edition 2021-07 |
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator |
| 06/07/2021 |
Anesthesiology |
1-151 |
Complete |
ISO |
80601-2-70 Second edition 2020-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 06/07/2021 |
Biocompatibility |
2-290 |
Partial |
ISO |
TS 37137-1 First edition 2021-03 |
Biological evaluation of absorbable medical devices - Part 1: General requirements. |
| 06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
| 06/07/2021 |
Cardiovascular |
3-129 |
Partial |
ANSI AAMI |
EC53:2013/(R)2020 |
ECG trunk cables and patient leadwires |
| 06/07/2021 |
Cardiovascular |
3-166 |
Partial |
ISO |
81060-2 Third edition 2018-11 [Including AMD1:2020] |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
| 06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| 06/07/2021 |
Dental/
ENT |
4-273 |
Complete |
ANSI ASA |
S3.7-2016 (Reaffirmed 2023) |
American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 |
Dental/
ENT |
4-274 |
Complete |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 06/07/2021 |
Dental/
ENT |
4-275 |
Complete |
ANSI ASA |
S3.6-2018 (Reaffirmed 2023) |
American National Standard for Specification for Audiometers |
| 06/07/2021 |
Dental/
ENT |
4-276 |
Partial |
ISO |
14457 Second edition 2017-10 |
Dentistry - Handpieces and motors |
| ANSI ADA |
Standard No. 35-2019 |
Dental Handpieces and Motors |
| 06/07/2021 |
Dental/
ENT |
4-277 |
Complete |
ANSI IEEE |
C63.19-2019 |
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids |
| 06/07/2021 |
Dental/
ENT |
4-278 |
Complete |
ISO |
4823 Fifth edition 2021-02 |
Dentistry - Elastomeric impression and bite registration materials |
| ANSI ADA |
Standard No. 19-2022 |
Elastomeric Impression and Bite Registration |
| 06/07/2021 |
Dental/
ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 06/07/2021 |
Dental/
ENT |
4-280 |
Partial |
ANSI ADA |
Standard No. 117-2018 |
Fluoride varnishes |
| 06/07/2021 |
Dental/
ENT |
4-281 |
Complete |
ISO |
1797 Third Edition 2017-05 |
Dentistry - Shanks for rotary and oscillating instruments |
| ANSI ADA |
Standard No. 179-2020 |
Shanks for Rotary and Oscillating Instruments |
| 06/07/2021 |
Dental/
ENT |
4-283 |
Complete |
ISO |
16409 Second edition 2016-10 |
Dentistry - Oral care products - Manual interdental brushes |
| ANSI ADA |
Standard No. 125-2018 |
Manual Interdental Brushes |
| 06/07/2021 |
General II (ES/
EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-389 |
Partial |
IEC |
60601-2-2 Edition 6.0 2017-03 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ANSI AAMI IEC |
60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-461 |
Complete |
IEC |
60601-2-19 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-463 |
Complete |
IEC |
60601-2-21 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| 06/07/2021 |
InVitro Diagnostics |
7-236 |
Partial |
CLSI |
M43-A October 2011 |
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline |
| 06/07/2021 |
InVitro Diagnostics |
7-262 |
Partial |
CLSI |
M45 3rd Edition |
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria |
| 06/07/2021 |
InVitro Diagnostics |
7-292 |
Partial |
CLSI |
M62 1st Edition |
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes |
| 06/07/2021 |
InVitro Diagnostics |
7-306 |
Complete |
CLSI |
EP06 2nd Edition |
Evaluation of the Linearity of Quantitative Measurement Procedures |
| 06/07/2021 |
InVitro Diagnostics |
7-307 |
Complete |
CLSI |
POCT05 2nd Edition |
Performance Metrics for Continuous Interstitial Glucose Monitoring |
| 06/07/2021 |
Materials |
8-555 |
Complete |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 06/07/2021 |
Materials |
8-558 |
Complete |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 06/07/2021 |
Materials |
8-562 |
Complete |
ISO ASTM |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 06/07/2021 |
Ophthalmic |
10-122 |
Partial |
ISO |
10939 Third edition 2017-05 |
Ophthalmic instruments - Slit-lamp microscopes |
| 06/07/2021 |
Ophthalmic |
10-123 |
Partial |
ISO |
15004-1 Second edition 2020-5 |
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
| 06/07/2021 |
Ophthalmic |
10-124 |
Complete |
ISO |
11979-1 Fourth edition 2018-11 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| 06/07/2021 |
Ophthalmic |
10-125 |
Partial |
ISO |
11979-7 Fourth edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
| 06/07/2021 |
Ophthalmic |
10-126 |
Complete |
IEC |
80601-2-58 Edition 2.0 2014-09 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| ANSI AAMI IEC |
80601-2-58:2014 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| 06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| 06/07/2021 |
Orthopedic |
11-377 |
Complete |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
| 06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
![Sort by Date [Old to new]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Date [New to old]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
