|
|
|
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)
|
| 08/14/2015 |
Materials |
8-389 |
Complete |
ISO |
15309 First edition 2013-12-01 |
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
| 08/14/2015 |
Radiology |
12-292 |
Complete |
IEEE |
Std 3333.2.1-2015 |
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
| 12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 09/17/2018 |
Materials |
8-475 |
Complete |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 08/06/2013 |
Software/
Informatics |
13-61 |
Complete |
IEC |
62443-2-1 Edition 1.0 2010-11 |
Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
| 01/14/2019 |
Anesthesiology |
1-117 |
Complete |
ISO |
5366 First edition 2016-10-01 |
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
| 07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 07/15/2019 |
Orthopedic |
11-357 |
Complete |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| 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 |
| 08/06/2013 |
Cardiovascular |
3-87 |
Complete |
ASTM |
F2477-07 (Reapproved 2013) |
Standard Test Methods for in vitro Pulsatile Durability |
| 05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| 01/14/2019 |
Sterility |
14-518 |
Complete |
AAMI ANSI |
ST55:2016/(R)2023 |
Table-top steam sterilizers |
| 07/26/2016 |
Biocompatibility |
2-170 |
Complete |
ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
| ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
| 01/14/2019 |
Neurology |
17-14 |
Complete |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 01/14/2019 |
Physical Medicine |
16-204 |
Complete |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
| 01/14/2019 |
Cardiovascular |
3-79 |
Complete |
ASTM |
F2079-09 (Reapproved 2017) |
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| 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 |
Anesthesiology |
1-164 |
Complete |
ISO |
5361 Fourth edition 2023-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
Complete |
ISO |
23908 First edition 2011-06-11 |
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 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 |
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 |
Materials |
8-569 |
Complete |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 07/15/2019 |
Sterility |
14-529 |
Complete |
ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
| ANSI AAMI ISO |
11135:2014/A1:2018 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release |
| 12/23/2019 |
Materials |
8-522 |
Complete |
ASTM |
F2129-19a |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| 07/06/2020 |
Materials |
8-534 |
Complete |
ISO ASTM |
52911-1: First Edition 2019-07 |
Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
| 07/06/2020 |
Materials |
8-535 |
Complete |
ISO ASTM |
52911-2: First Edition 2019-09 |
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
| 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 |
| 12/23/2016 |
InVitro Diagnostics |
7-267 |
Complete |
CLSI |
C24 4th Edition (Replaces C24-A3) |
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
| 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 |
| 12/20/2021 |
Materials |
8-570 |
Complete |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 12/23/2019 |
Physical Medicine |
16-223 |
Complete |
RESNA ANSI |
WC-1:2019 Section 22 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures |
| 12/23/2019 |
Physical Medicine |
16-224 |
Complete |
RESNA ANSI |
WC-2:2019 Section 21 |
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters |
| 12/21/2020 |
Biocompatibility |
2-279 |
Complete |
ASTM |
F750-20 |
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
| 12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
| 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 |
| 12/23/2019 |
Physical Medicine |
16-211 |
Complete |
RESNA ANSI |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
| 12/23/2019 |
Physical Medicine |
16-219 |
Complete |
RESNA ANSI |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
| 07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| 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 |
| 12/20/2021 |
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 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 |
| 12/19/2022 |
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
|
| 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 |
| 12/19/2022 |
Biocompatibility |
2-297 |
Complete |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| 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 |
| 12/19/2022 |
Anesthesiology |
1-157 |
Complete |
ISO |
10079-1 Fourth edition 2022-03 |
Medical suction equipment - Part 1: Electrically powered suction equipment |
| 12/18/2023 |
Dental/
ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
| 12/18/2023 |
InVitro Diagnostics |
7-318 |
Complete |
CLSI |
EP25 2nd Edition |
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents |
| 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 |
| 01/14/2019 |
InVitro Diagnostics |
7-285 |
Complete |
CLSI |
M48-A 2nd Edition |
Laboratory Detection and Identification of Mycobacteria |
| 07/06/2020 |
InVitro Diagnostics |
7-297 |
Complete |
ISO |
TS 20914 First edition 2019-07 |
Medical laboratories - Practical guidance for the estimation of measurement uncertainty |
| 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) |
| 12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| 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 |
| 04/04/2016 |
Dental/
ENT |
4-221 |
Complete |
ISO |
7494-2 Second edition 2015-04-01 |
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
| 12/18/2023 |
Materials |
8-610 |
Complete |
ASTM |
F601-23 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 01/14/2019 |
Materials |
8-483 |
Complete |
ASTM |
F601-18 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 01/15/2013 |
InVitro Diagnostics |
7-235 |
Complete |
CLSI |
EP25-A (Replaces EP25-P) |
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 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 |
| 12/23/2016 |
Biocompatibility |
2-93 |
Complete |
ASTM |
F763-04 (Reapproved 2016) |
Standard Practice for Short-Term Screening of Implant Materials |
| 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 |
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) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 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 |
InVitro Diagnostics |
7-313 |
Complete |
CLSI |
EP27 2nd Edition |
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| 03/31/2006 |
Radiology |
12-136 |
Complete |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
| 08/02/2011 |
Ophthalmic |
10-66 |
Complete |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
| 01/30/2014 |
Sterility |
14-429 |
Complete |
ISO ASTM |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
| 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 |
General Plastic Surgery/
General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
| 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 |
Software/
Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
| 04/04/2016 |
Materials |
8-394 |
Complete |
ASTM |
F1472-14 |
Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 06/07/2021 |
Radiology |
12-340 |
Complete |
IEC |
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
| 08/06/2013 |
Radiology |
12-205 |
Complete |
IEC |
60601-2-5: Edition 3.0 2009-07 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-466 |
Complete |
USP-NF |
M76070_03_01 |
Sodium Chloride Injection |
| 01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| 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 |
| 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 |
6-475 |
Complete |
ISO |
11608-4:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics |
| 01/14/2019 |
Dental/
ENT |
4-254 |
Complete |
ANSI ADA |
Standard No. 99-2001 (R2013) |
Athletic Mouth Protectors and Materials |
| 12/23/2019 |
Physical Medicine |
16-225 |
Complete |
RESNA ANSI |
WC-1:2019 Section 26 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
| 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 |
| 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) |
| 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)] |
| 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 |
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 |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
| 12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| 01/30/2014 |
Dental/
ENT |
4-181 |
Complete |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
| 06/27/2016 |
Dental/
ENT |
4-227 |
Complete |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
| 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) |
5-138 |
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 |
| 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 |
| 06/07/2018 |
Dental/
ENT |
4-240 |
Complete |
ISO |
21563 First edition 2013-08-15 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2015 |
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 |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 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 |
| 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 |
| 12/20/2021 |
Dental/
ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
| 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 |
| 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 |
Dental/
ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
| 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 |
| 06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Software/
Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 08/06/2013 |
Ophthalmic |
10-77 |
Complete |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| 12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| 12/23/2016 |
Sterility |
14-497 |
Complete |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 01/14/2019 |
Anesthesiology |
1-141 |
Complete |
ISO |
80601-2-13 First edition 2011-08-11 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
| 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 |
| 05/30/2022 |
Cardiovascular |
3-181 |
Complete |
ISO |
25539-2 Third edition 2020-09 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| 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 |
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 |
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 |
| 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 |
| 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 |
| 12/19/2022 |
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 |
| 12/20/2021 |
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 |
| 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 |
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 |
| 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 |
General Plastic Surgery/
General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 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. |
| 06/07/2021 |
Materials |
8-555 |
Complete |
ASTM |
F1472-20a |
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) |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 12/21/2020 |
Orthopedic |
11-371 |
Complete |
ASTM |
F2009-20 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 06/07/2021 |
Sterility |
14-562 |
Complete |
ANSI AAMI |
ST79:2017 & 2020 Amendments A1, A2, A3, A4 |
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| 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 |
| 05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 01/27/2015 |
Dental/
ENT |
4-219 |
Complete |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 01/30/2014 |
Materials |
8-344 |
Complete |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| 01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
| 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 2018-03 |
Dentistry - Polymer-based luting materials containing adhesive components |
| 12/18/2023 |
Anesthesiology |
1-166 |
Complete |
ISO |
11195 Second edition 2018-01 |
Gas mixers for medical use - Stand-alone gas mixers |
| 12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| 12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
| 07/06/2020 |
General I (QS/
RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 04/04/2016 |
Materials |
8-200 |
Complete |
ASTM |
F2003-02 (Reapproved 2015) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 06/07/2021 |
Tissue Engineering |
15-67 |
Complete |
ASTM |
F2212-20 |
Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| 01/30/2014 |
Cardiovascular |
3-118 |
Complete |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
| 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 |
| 12/23/2016 |
Anesthesiology |
1-118 |
Complete |
ISO |
5361 Third edition 2016-09-01 |
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 |
| 12/23/2019 |
Anesthesiology |
1-145 |
Complete |
ISO |
19223 First edition 2019-07 |
Lung ventilators and related equipment - Vocabulary and semantics. |
| 05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 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 |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 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 |
| 05/30/2022 |
Sterility |
14-576 |
Complete |
ASTM |
D4169-22 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
| 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 |
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 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 07/15/2019 |
Biocompatibility |
2-266 |
Complete |
ASTM |
F2382-18 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
| 12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
| 12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
| 12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
| 07/15/2019 |
Sterility |
14-533 |
Complete |
ISO |
TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| 07/06/2020 |
Nanotechnology |
18-16 |
Complete |
ISO |
TS 21362 First edition 2018-06 |
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation |
| 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 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
| 04/04/2016 |
Sterility |
14-340 |
Complete |
ISO |
20857 First edition 2010-08-15 |
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
20857:2010/(R)2015 |
(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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)] |
| 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)] |
| 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 |
Dental/
ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/20/2021 |
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 |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-381 |
Complete |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
| 07/15/2019 |
Orthopedic |
11-358 |
Complete |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-450 |
Complete |
IEC |
60601-2-50 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| 07/06/2020 |
General I (QS/
RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
| 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 |
| 07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
| 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 |
| 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 |
| 12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/21/2020 |
Ophthalmic |
10-120 |
Complete |
ISO |
TR 22979 Second Edition 2017-05 |
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
| 12/21/2020 |
InVitro Diagnostics |
7-300 |
Complete |
CLSI |
MM13 2nd Edition |
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| 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 |
| 12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
| 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 |
| 01/14/2019 |
Cardiovascular |
3-44 |
Complete |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
| 06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| 07/15/2019 |
Orthopedic |
11-354 |
Complete |
ASTM |
F3295-18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
| 12/21/2020 |
Orthopedic |
11-374 |
Complete |
ISO |
7207-2 Second edition 2011-07-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)] |
| 06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| 01/14/2019 |
Dental/
ENT |
4-250 |
Complete |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-251 |
Complete |
ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| 12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 07/06/2020 |
Materials |
8-526 |
Complete |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 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 |
| 07/15/2019 |
Materials |
8-495 |
Complete |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| 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 |
4-283 |
Complete |
ISO |
16409 Second edition 2016-10 |
Dentistry - Oral care products - Manual interdental brushes |
| ANSI ADA |
Standard No. 125-2018 |
Manual Interdental Brushes |
| 04/04/2016 |
Anesthesiology |
1-115 |
Complete |
ISO |
80601-2-70 First Edition 2015-01-15 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 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 |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)] |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 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 |
| 12/21/2020 |
General II (ES/
EMC) |
19-39 |
Complete |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)] |
| 07/15/2019 |
Materials |
8-516 |
Complete |
ISO |
13779-4 Second edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength |
| 01/14/2019 |
Materials |
8-485 |
Complete |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 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 |
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 |
| 01/30/2014 |
Cardiovascular |
3-54 |
Complete |
ANSI AAMI ISO |
7198:2016 Second edition |
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
| 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 |
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 |
Dental/
ENT |
4-285 |
Complete |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
| 12/21/2020 |
Materials |
8-548 |
Complete |
ISO ASTM |
52915 Third edition 2020-03 |
Specification for additive manufacturing file format (AMF) Version 1.2 |
| 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 |
4-275 |
Complete |
ANSI ASA |
S3.6-2018 |
American National Standard for Specification for Audiometers |
| 12/21/2020 |
Biocompatibility |
2-277 |
Complete |
ASTM |
F813-20 |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| 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)] |
| 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 |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 05/30/2022 |
InVitro Diagnostics |
7-312 |
Complete |
CLSI |
M39 5th Edition |
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| 07/06/2020 |
Biocompatibility |
2-273 |
Complete |
ISO |
10993-9 Third edition 2019-11 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
| 12/20/2021 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 12/21/2020 |
InVitro Diagnostics |
7-301 |
Complete |
CLSI |
GP42 7th Edition |
Collection of Capillary Blood Specimens |
| 12/21/2020 |
InVitro Diagnostics |
7-302 |
Complete |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| 12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| 07/15/2019 |
Biocompatibility |
2-268 |
Complete |
ISO |
TS 21726 First edition 2019-02 |
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents |
| 12/21/2020 |
Nanotechnology |
18-17 |
Complete |
ISO |
21363 First edition 2020-06 |
Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy |
| 12/21/2020 |
Biocompatibility |
2-278 |
Complete |
ASTM |
F719-20 e1 |
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation |
| 12/21/2020 |
Materials |
8-549 |
Complete |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
| 09/17/2018 |
Materials |
8-479 |
Complete |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
| 01/14/2019 |
InVitro Diagnostics |
7-139 |
Complete |
CLSI |
QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 |
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
| 12/23/2019 |
Materials |
8-519 |
Complete |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| 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 |
| 07/15/2019 |
Biocompatibility |
2-267 |
Complete |
ASTM |
F2888-19 |
Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
| 12/23/2019 |
Physical Medicine |
16-215 |
Complete |
RESNA ANSI |
WC-2:2019 Section 9 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs |
| 07/06/2020 |
Biocompatibility |
2-274 |
Complete |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| 09/17/2018 |
Orthopedic |
11-185 |
Complete |
ASTM |
F2267-04 (Reapproved 2018) |
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 06/07/2018 |
Anesthesiology |
1-135 |
Complete |
ISO |
18562-2 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
| 07/15/2019 |
InVitro Diagnostics |
7-288 |
Complete |
CLSI |
M24 3rd Edition |
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
| 07/15/2019 |
Sterility |
14-532 |
Complete |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| 12/21/2020 |
Biocompatibility |
2-281 |
Complete |
ISO |
TS 10993-19 Second edition 2020-03 |
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
| 09/17/2018 |
Radiology |
12-319 |
Complete |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 12/23/2019 |
Physical Medicine |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
| 12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
| 06/27/2016 |
Orthopedic |
11-307 |
Complete |
ASTM |
F2385-15 (Reapproved 2019) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
| 12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
| 06/07/2021 |
Radiology |
12-338 |
Complete |
IEC |
60601-2-1 Edition 4.0 2020-10 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| 12/23/2019 |
Physical Medicine |
16-218 |
Complete |
RESNA ANSI |
WC-1:2019 Section 13 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces |
| 06/07/2021 |
Orthopedic |
11-381 |
Complete |
ASTM |
F2582-20 |
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
| 01/14/2019 |
Dental/
ENT |
4-162 |
Complete |
ANSI ASA |
S3.4-2007 (Reaffirmed 2020) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| 07/09/2014 |
Dental/
ENT |
4-160 |
Complete |
ANSI ASA |
S3.1-1999 (Reaffirmed 2023) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
| 12/23/2019 |
Physical Medicine |
16-222 |
Complete |
RESNA ANSI |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
| 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 |
| 12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 01/14/2019 |
Dental/
ENT |
4-252 |
Complete |
ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| 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 |
| 04/04/2016 |
ObGyn/
Gastroenterology/
Urology |
9-113 |
Complete |
CEN |
EN 1618:1997 |
Catheters other than intravascular catheters - Test methods for common properties |
| 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 |
| 01/14/2019 |
Anesthesiology |
1-138 |
Complete |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 01/14/2019 |
Dental/
ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
| 01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
| 04/04/2016 |
Radiology |
12-195 |
Complete |
NEMA |
MS 6-2008 (R2014, R2020) |
Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging |
| 07/09/2014 |
Radiology |
12-273 |
Complete |
IEC |
60825-1 Edition 2.0 2007-03 |
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| 12/21/2020 |
Dental/
ENT |
4-269 |
Complete |
ISO |
3964 Third edition 11-2016 |
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| 12/23/2019 |
Physical Medicine |
16-207 |
Complete |
RESNA ANSI |
WC-1:2019 Section 1 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability |
| 12/23/2019 |
Physical Medicine |
16-209 |
Complete |
RESNA ANSI |
WC-1:2019 Section 3 |
American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes |
| 12/23/2019 |
Physical Medicine |
16-210 |
Complete |
RESNA ANSI |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
| 12/21/2020 |
General I (QS/
RM) |
5-133 |
Complete |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| 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)] |
| 03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-127 |
Complete |
ISO CIE |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
| 01/14/2019 |
Nanotechnology |
18-6 |
Complete |
ASTM |
E2865-12 (Reapproved 2022) |
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials |
| 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 |
| 06/07/2021 |
InVitro Diagnostics |
7-306 |
Complete |
CLSI |
EP06 2nd Edition |
Evaluation of the Linearity of Quantitative Measurement Procedures |
| 12/21/2020 |
Materials |
8-538 |
Complete |
ASTM |
F2759-19 |
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
| 07/15/2019 |
Orthopedic |
11-353 |
Complete |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| 07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
| 12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 12/21/2020 |
Materials |
8-537 |
Complete |
ASTM |
F620-20 |
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
| 12/21/2020 |
Anesthesiology |
1-147 |
Complete |
ISO |
26825 Second edition 2020-10 |
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance |
| 12/21/2020 |
Anesthesiology |
1-149 |
Complete |
ISO |
7376 Third edition 2020-08 |
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation |
| 06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/21/2020 |
Anesthesiology |
1-150 |
Complete |
ISO |
8836 Fifth edition 2019-12 |
Suction catheters for use in the respiratory tract |
| 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 |
10-126 |
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)] |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
Complete |
ASTM |
D7103-19(2023) |
Standard Guide for Assessment of Medical Gloves |
| 07/06/2020 |
Anesthesiology |
1-146 |
Complete |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 12/23/2019 |
Cardiovascular |
3-162 |
Complete |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| 12/23/2019 |
InVitro Diagnostics |
7-295 |
Complete |
CLSI |
M52, 1st ed. August 2015 (Reaffirmed: January 2020) |
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/23/2019 |
InVitro Diagnostics |
7-293 |
Complete |
CLSI |
QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
A Quality Management System Model for Laboratory Services. |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
Materials |
8-541 |
Complete |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/21/2020 |
Materials |
8-542 |
Complete |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Tissue Engineering |
15-65 |
Complete |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| 06/07/2021 |
Tissue Engineering |
15-66 |
Complete |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
| 12/21/2020 |
Materials |
8-550 |
Complete |
ASTM |
F2181-20 |
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
| 12/21/2020 |
Materials |
8-551 |
Complete |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
| 01/14/2019 |
Nanotechnology |
18-7 |
Complete |
ASTM |
E2834-12 (Reapproved 2022) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) |
| 12/23/2019 |
Orthopedic |
11-362 |
Complete |
ISO |
22622 First edition 2019-07 |
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
| 01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
| 07/15/2019 |
Ophthalmic |
10-89 |
Partial |
ANSI |
Z80.7-2013 (R2023) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
| 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 |
| 12/23/2019 |
Cardiovascular |
3-163 |
Partial |
ISO |
18242 First edition 2016-09-01 |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps. |
| 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 |
| 01/14/2019 |
Cardiovascular |
3-159 |
Partial |
ISO |
5910 First edition 2018-06 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 01/14/2019 |
Ophthalmic |
10-93 |
Partial |
ANSI |
Z80.27-2014 (R2019) |
American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| 07/15/2019 |
InVitro Diagnostics |
7-289 |
Partial |
CLSI |
MM17 2nd Edition |
Verification and Validation of Multiplex Nucleic Acid Assays |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-178 |
Partial |
ASTM |
D6124-06(2022) |
Standard Test Method for Residual Powder on Medical Gloves |
| 01/14/2019 |
Ophthalmic |
10-74 |
Partial |
ISO |
10940 Second edition 2009-08-01 |
Ophthalmic instruments - Fundus cameras |
| 01/14/2019 |
Ophthalmic |
10-85 |
Partial |
ISO |
11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 01/14/2019 |
Ophthalmic |
10-86 |
Partial |
ISO |
14729 First edition 2001-04-15 |
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
| 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 |
| 01/14/2019 |
Ophthalmic |
10-108 |
Partial |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| 04/04/2016 |
Anesthesiology |
1-106 |
Partial |
ISO |
17510 First Edition 2015-08-01 |
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-445 |
Partial |
ASTM |
D5250-19(2023) |
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
| 07/15/2019 |
InVitro Diagnostics |
7-290 |
Partial |
CLSI |
EP34 1st Edition |
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking |
| 07/15/2019 |
Dental/
ENT |
4-259 |
Partial |
ISO |
14801 Third edition 2016-11-01 |
Dentistry - Implants - Dynamic loading test for endosseous dental implants |
| ANSI ADA |
Standard No. 127-2018 |
Dynamic Loading Test for Endosseous Dental Implants |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-446 |
Partial |
ASTM |
D6319-19(2023) |
Standard Specification for Nitrile Examination Gloves for Medical Application |
| 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. |
| 07/26/2016 |
Biocompatibility |
2-240 |
Partial |
ANSI AAMI ISO |
TIR 10993-20:2006 |
Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO |
TS 10993-20 First edition 2006-08-01 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| 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 |
Cardiovascular |
3-166 |
Partial |
ISO |
81060-2 Third edition 2018-11 |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
| 06/07/2021 |
Cardiovascular |
3-129 |
Partial |
ANSI AAMI |
EC53:2013/(R)2020 |
ECG trunk cables and patient leadwires |
| 01/14/2019 |
Biocompatibility |
2-258 |
Partial |
ISO |
10993-1 Fifth edition 2018-08 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ANSI AAMI ISO |
10993-1: 2018 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 01/14/2019 |
Cardiovascular |
3-86 |
Partial |
ASTM |
F2394-07 (Reapproved 2017) |
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| 01/14/2019 |
Orthopedic |
11-184 |
Partial |
ISO |
8827 First edition 1988-10-15 |
Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
| 04/04/2016 |
InVitro Diagnostics |
7-259 |
Partial |
CLSI |
GP23-A2 (Replaces GP23-A) |
Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
| 01/14/2019 |
Orthopedic |
11-348 |
Partial |
ISO |
19227 First edition 2018-03 |
Implants for surgery - Cleanliness of orthopedic implants - General requirements |
| 07/06/2020 |
Cardiovascular |
3-123 |
Partial |
IEC |
80601-2-30: Edition 2.0 2018-03 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ANSI AAMI IEC |
80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers |
| 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 |
| 04/04/2016 |
Tissue Engineering |
15-44 |
Partial |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
| 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 |
| 07/06/2020 |
Biocompatibility |
2-276 |
Partial |
ISO |
10993-18 Second edition 2020-01 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process. |
| 06/27/2016 |
General I (QS/
RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-442 |
Partial |
ASTM |
D6977-19(2023) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
| 12/23/2016 |
Materials |
8-439 |
Partial |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
| 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 |
| 01/30/2014 |
InVitro Diagnostics |
7-220 |
Partial |
CLSI |
H59-A (Replaces H59-P) |
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
| 01/14/2019 |
Nanotechnology |
18-2 |
Partial |
ASTM |
E2535-07 (Reapproved 2018) |
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-443 |
Partial |
ASTM |
D3577-19 |
Standard Specification for Rubber Surgical Gloves |
| 12/23/2016 |
Biocompatibility |
2-244 |
Partial |
ASTM |
F748-16 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 12/18/2023 |
Nanotechnology |
18-24 |
Partial |
ASTM |
E2524-22 |
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
| 07/26/2016 |
Biocompatibility |
2-169 |
Partial |
ISO |
10993-13 Second edition 2010-06-15 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ANSI AAMI ISO |
10993-13:2010/(R)2014 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 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 |
| 01/14/2019 |
InVitro Diagnostics |
7-269 |
Partial |
CLSI |
MM23-1st Edition |
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) |
| 01/14/2019 |
Cardiovascular |
3-52 |
Partial |
ANSI AAMI |
EC12:2000/(R)2015 |
Disposable ECG electrodes |
| 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 |
| 09/17/2018 |
Anesthesiology |
1-139 |
Partial |
ISO |
80601-2-61 Second edition 2017-12 (Corrected version 2018-02) |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| 08/14/2015 |
Anesthesiology |
1-103 |
Partial |
ISO |
5367 Fifth edition 2014-10-15 |
Anaesthetic and respiratory equipment - Breathing sets and connectors |
| 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 |
| 07/26/2016 |
Biocompatibility |
2-237 |
Partial |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| 01/30/2014 |
Sterility |
14-334 |
Partial |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
| ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
| 01/30/2014 |
Sterility |
14-336 |
Partial |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
| 06/07/2018 |
Anesthesiology |
1-137 |
Partial |
ISO |
18562-4 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| 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 |
InVitro Diagnostics |
7-317 |
Partial |
CLSI |
M100, 33rd Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 06/07/2018 |
Neurology |
17-1 |
Partial |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
| 08/21/2017 |
Software/
Informatics |
13-92 |
Partial |
ISO IEEE |
11073-10421 First edition 2012-11-01 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 04/04/2016 |
Materials |
8-409 |
Partial |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
| 06/07/2021 |
Dental/
ENT |
4-280 |
Partial |
ANSI ADA |
Standard No. 117-2018 |
Fluoride varnishes |
| 01/30/2014 |
InVitro Diagnostics |
7-210 |
Partial |
CLSI |
H26-A2 |
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
| 06/27/2016 |
Cardiovascular |
3-143 |
Partial |
ISO |
12417 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products |
| 09/17/2018 |
Materials |
8-473 |
Partial |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
| 06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
| 08/14/2015 |
Neurology |
17-4 |
Partial |
ASTM |
F647-94 (Reapproved 2014) |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 09/17/2018 |
General II (ES/
EMC) |
19-19 |
Partial |
IEC |
TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 06/27/2016 |
Radiology |
12-295 |
Partial |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| 12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-359 |
Partial |
ISO |
8536-9 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-361 |
Partial |
ISO |
8536-11 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion 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 |
| 07/26/2016 |
Biocompatibility |
2-228 |
Partial |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
| 01/14/2019 |
Materials |
8-179 |
Partial |
ASTM |
F754-08 (Reapproved 2015) |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| 08/14/2015 |
InVitro Diagnostics |
7-255 |
Partial |
CLSI |
MM09-A2 (Replaces MM09-A) |
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition |
| 08/06/2013 |
InVitro Diagnostics |
7-234 |
Partial |
CLSI |
EP24-A2 (Replaces GP 10-A) |
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition |
| 08/06/2013 |
Software/
Informatics |
13-54 |
Partial |
ISO IEEE |
11073-10404 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
| 08/06/2013 |
InVitro Diagnostics |
7-243 |
Partial |
CLSI |
M51-A (Replaces M51-P) |
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
| 01/27/2015 |
InVitro Diagnostics |
7-250 |
Partial |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
| 08/21/2017 |
InVitro Diagnostics |
7-272 |
Partial |
CLSI |
C57 1st Edition (Reaffirmed: January 2020) |
Mass Spectrometry for Androgen and Estrogen Measurements in Serum |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-257 |
Partial |
ISO |
17730 First edition 2014-11-01 |
Dentistry - Fluoride varnishes |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-118 |
Partial |
ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 06/27/2016 |
InVitro Diagnostics |
7-264 |
Partial |
CLSI |
MM21-1st Edition (Reaffirmed: January 2020) |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
| 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 |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-358 |
Partial |
ISO |
8536-8 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-360 |
Partial |
ISO |
8536-10 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment |
| 12/23/2016 |
InVitro Diagnostics |
7-268 |
Partial |
CLSI |
EP21 2nd Edition (Replaces EP21-A) |
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| 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 |
| 07/26/2016 |
Biocompatibility |
2-191 |
Partial |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| 08/14/2015 |
Sterility |
14-460 |
Partial |
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 |
| 08/21/2017 |
Ophthalmic |
10-104 |
Partial |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-449 |
Partial |
ASTM |
F1169-19 |
Standard Consumer Safety Specification for Full-Size Baby Cribs |
| 01/27/2015 |
Nanotechnology |
18-3 |
Partial |
ISO |
TS 14101 First edition 2012-11-01 |
Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method |
| 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 |
| 12/18/2023 |
General Plastic Surgery/
General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 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 |
| 08/14/2015 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| 08/14/2015 |
Software/
Informatics |
13-73 |
Partial |
IHTSDO |
SNOMED-CT RF2 Release 2015 |
Systematized Nomenclature of Medicine - Clinical Terms |
| 06/07/2018 |
Anesthesiology |
1-134 |
Partial |
ISO |
18562-1 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| 12/18/2023 |
InVitro Diagnostics |
7-320 |
Partial |
CLSI |
H62 1st Edition |
Validation of Assays Performed by Flow Cytometry |
| 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)]. |
| 12/20/2021 |
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) |
| 12/21/2020 |
Orthopedic |
11-330 |
Partial |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
| 12/21/2020 |
Tissue Engineering |
15-64 |
Partial |
ISO |
22442-1 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| 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 |
| 07/15/2019 |
InVitro Diagnostics |
7-291 |
Partial |
CLSI |
EP27-A |
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition |
| 12/19/2022 |
InVitro Diagnostics |
7-314 |
Partial |
CLSI |
M27M44S, 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| 09/21/2016 |
InVitro Diagnostics |
7-265 |
Partial |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
| 12/19/2022 |
Ophthalmic |
10-132 |
Partial |
ISO |
10942 Third edition 2022-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
| 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 |
| 06/07/2021 |
Software/
Informatics |
13-117 |
Partial |
IEEE |
Std 11073-40101-2020 |
Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment. |
| 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 |
| 12/20/2021 |
Cardiovascular |
3-174 |
Partial |
ISO |
5840-1 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 01/27/2015 |
Software/
Informatics |
13-71 |
Partial |
RII |
Version 2.48 |
Logical Observation Identifiers Names and Codes (LOINC) |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-440 |
Partial |
ASTM |
D3578-19(2023) |
Standard Specification for Rubber Examination Gloves |
| 07/15/2019 |
Ophthalmic |
10-116 |
Partial |
ANSI |
Z80.35-2018 (R2023) |
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
| 12/21/2020 |
Materials |
8-543 |
Partial |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 09/17/2018 |
Ophthalmic |
10-56 |
Partial |
ANSI |
Z80.12-2007 (R2022) |
American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
| 12/21/2020 |
Cardiovascular |
3-169 |
Partial |
IEC |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ANSI AAMI IEC |
60601-2-4:2010/A1:2018 (Consolidated Text) |
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
| 12/21/2020 |
Biocompatibility |
2-288 |
Partial |
ISO |
10993-15 Second edition 2019-11 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
| 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 |
10-122 |
Partial |
ISO |
10939 Third edition 2017-05 |
Ophthalmic instruments - Slit-lamp microscopes |
| 12/21/2020 |
General II (ES/
EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 05/30/2022 |
Sterility |
14-572 |
Partial |
ANSI AAMI |
ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
| 07/15/2019 |
Nanotechnology |
18-14 |
Partial |
ISO |
TR 11360 First edition 2010-07-15 |
Nanotechnologies - Methodology for the classification and categorization of nanomaterials |
| 06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
| 07/15/2019 |
Nanotechnology |
18-13 |
Partial |
ISO |
TS 18827 First edition 2017-06 |
Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials |
| 12/21/2020 |
General II (ES/
EMC) |
19-36 |
Partial |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-408 |
Partial |
ISO |
10555-1 Second edition 2013-06-15 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
| 06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
| 07/26/2016 |
Biocompatibility |
2-243 |
Partial |
ISO |
TR 10993-33 First Edition 2015-03-01 |
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 |
| 10/17/2014 |
ObGyn/
Gastroenterology/
Urology |
9-95 |
Partial |
CEN |
EN 1615:2000 |
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing |
| 06/07/2021 |
InVitro Diagnostics |
7-236 |
Partial |
CLSI |
M43-A October 2011 |
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 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 |
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 |
| 12/23/2019 |
ObGyn/
Gastroenterology/
Urology |
9-123 |
Partial |
ISO |
8600-3 Second edition 2019-08 |
Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
| 07/06/2020 |
InVitro Diagnostics |
7-296 |
Partial |
CLSI |
EP09c 3rd Edition |
Measurement Procedure Comparison and Bias Estimation Using Patient Samples |
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