|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/21/2020 |
Materials |
8-554 |
ASTM ISO |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
12/21/2020 |
Materials |
8-537 |
ASTM |
F620-20 |
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
06/27/2016 |
Materials |
8-217 |
ASTM |
F620-11 (Reapproved 2015) |
Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
12/21/2020 |
Anesthesiology |
1-147 |
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 |
ObGyn/ Gastroenterology/ Urology |
9-130 |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
07/15/2019 |
Materials |
8-496 |
ISO |
5834-4 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method |
07/06/2020 |
General Plastic Surgery/ General Hospital |
6-444 |
ASTM |
D7103-19 |
Standard Guide for Assessment of Medical Gloves |
12/21/2020 |
Orthopedic |
11-373 |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
12/21/2020 |
Orthopedic |
11-370 |
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 |
7-302 |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
12/21/2020 |
InVitro Diagnostics |
7-304 |
CLSI |
M23 5th Edition |
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters |
12/21/2020 |
InVitro Diagnostics |
7-305 |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
12/21/2020 |
General I (QS/ RM) |
5-131 |
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)] |
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 |
08/06/2013 |
General I (QS/ RM) |
5-76 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 |
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. |
IEC |
60601-1-8 Edition 2.1 2012-11 |
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 |
12/21/2020 |
General I (QS/ RM) |
5-132 |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
12/21/2020 |
Tissue Engineering |
15-65 |
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 |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
07/15/2019 |
Biocompatibility |
2-268 |
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 |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-377 |
ISO |
11608-5 First edition 2012-10-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function. |
07/06/2020 |
Anesthesiology |
1-146 |
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 |
06/07/2021 |
InVitro Diagnostics |
7-307 |
CLSI |
POCT05 2nd Edition |
Performance Metrics for Continuous Interstitial Glucose Monitoring |
06/27/2016 |
General I (QS/ RM) |
5-89 |
IEC |
60601-1-6 Edition 3.1 2013-10 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
12/21/2020 |
General II (ES/ EMC) |
19-37 |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
12/21/2020 |
Materials |
8-547 |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
06/27/2016 |
Materials |
8-421 |
ASTM |
F629-15 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
07/15/2019 |
Radiology |
12-326 |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
07/06/2020 |
General I (QS/ RM) |
5-126 |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-135 |
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 |
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 |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-136 |
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 |
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 |
01/14/2019 |
Radiology |
12-323 |
ISO |
11990 Third edition 2018-08 |
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
01/14/2019 |
Radiology |
12-324 |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
12/23/2019 |
Materials |
8-480 |
ASTM |
F2063-18 |
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
12/23/2019 |
Materials |
8-481 |
ASTM |
F1314-18 |
Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
12/23/2019 |
Materials |
8-484 |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-388 |
ANSI AAMI IEC |
60601-2-21:2009/A1:2016 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
IEC |
60601-2-21 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-137 |
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 |
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 |
07/06/2020 |
General I (QS/ RM) |
5-129 |
ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
06/07/2021 |
Orthopedic |
11-379 |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
06/07/2021 |
General Plastic Surgery/ General Hospital |
6-463 |
IEC |
60601-2-21 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
07/06/2020 |
General I (QS/ RM) |
5-127 |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
07/06/2020 |
General I (QS/ RM) |
5-128 |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
06/07/2021 |
Orthopedic |
11-376 |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-138 |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
12/21/2020 |
Dental/ ENT |
4-267 |
ANSI ADA |
Standard No. 105-2010 (R2015) |
Orthodontic Elastomeric Materials |
ISO |
21606 First edition 2007-06 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
12/21/2020 |
Ophthalmic |
10-121 |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
08/21/2017 |
Cardiovascular |
3-149 |
ISO |
25539-1 Second edition 2017-02 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
07/15/2019 |
Materials |
8-513 |
ISO |
20160 First edition 2006-05-01 |
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars |
07/15/2019 |
General II (ES/ EMC) |
19-35 |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
01/14/2019 |
Software/ Informatics |
13-105 |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
07/15/2019 |
Materials |
8-497 |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
07/15/2019 |
Orthopedic |
11-351 |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
12/23/2019 |
Software/ Informatics |
13-112 |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
06/07/2021 |
Orthopedic |
11-377 |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
12/21/2020 |
Materials |
8-538 |
ASTM |
F2759-19 |
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
12/21/2020 |
Materials |
8-539 |
ASTM |
F139-19 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
12/21/2020 |
Physical Medicine |
16-230 |
ANSI RESNA |
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 |
01/30/2014 |
Anesthesiology |
1-98 |
ISO |
80601-2-12 First edition 2011-04-15 |
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)] |
06/07/2021 |
Orthopedic |
11-384 |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
06/07/2021 |
Radiology |
12-336 |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
07/15/2019 |
Physical Medicine |
16-206 |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
07/15/2019 |
Orthopedic |
11-353 |
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 |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
12/21/2020 |
Anesthesiology |
1-148 |
ISO |
80601-2-69 Second edition 2020-11 |
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
01/14/2014 |
Radiology |
12-269 |
IEC |
60601-1-3 Edition 2.1 2013-04 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
12/21/2020 |
Ophthalmic |
10-119 |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
07/06/2020 |
Orthopedic |
11-364 |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
01/14/2019 |
Nanotechnology |
18-8 |
ASTM |
E2578-07 (Reapproved 2022) |
Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions |
01/14/2019 |
Nanotechnology |
18-11 |
ISO |
/TR 13121 First edition 2011-05-15 |
Nanotechnologies - Nanomaterial risk evaluation |
01/14/2019 |
Radiology |
12-322 |
NEMA |
MS 5-2018 |
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
07/15/2019 |
Tissue Engineering |
15-58 |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
07/06/2020 |
Software/ Informatics |
13-114 |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
07/06/2020 |
Software/ Informatics |
13-115 |
IEC IEEE ISO |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
07/06/2020 |
Materials |
8-531 |
ASTM |
F3321-19 |
Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
07/15/2019 |
Biocompatibility |
2-263 |
ASTM |
F1903-18 |
Standard Practice for Testing for Cellular Responses to Particles in vitro |
07/15/2019 |
General I (QS/ RM) |
5-123 |
ISO |
80369-3 First Edition 2016-07-01 |
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. |
07/15/2019 |
Ophthalmic |
10-118 |
ANSI |
Z80.38-2017 (R2021) |
American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery |
07/09/2014 |
General II (ES/ EMC) |
19-9 |
IEC |
60601-1-10 Edition 1.1 2013-11 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-321 |
IEC |
60601-2-52 Edition 1.0 2009-12 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
07/15/2019 |
Dental/ ENT |
4-258 |
ANSI ADA |
Standard No. 160-2020 |
Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use |
ISO |
10139-2 Third edition 2016-06-15 |
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
07/06/2020 |
Radiology |
12-332 |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
07/06/2020 |
Radiology |
12-334 |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
12/23/2016 |
General I (QS/ RM) |
5-114 |
ANSI AAMI IEC |
62366-1:2015 |
Medical devices - Part 1: Application of usability engineering to medical devices |
IEC |
62366-1 Edition 1.0 2015-02 |
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] |
12/23/2019 |
General I (QS/ RM) |
5-125 |
ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
07/06/2020 |
Radiology |
12-325 |
NEMA |
Standards Publication XR 25 -2019 |
Computed Tomography Dose Check |
12/21/2020 |
Materials |
8-541 |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
12/23/2019 |
Orthopedic |
11-362 |
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 |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-424 |
ASTM |
D5151-19 |
Standard Test Method for Detection of Holes in Medical Gloves |
12/23/2019 |
Dental/ ENT |
4-261 |
ISO |
7405 Third edition 2018-10 Corrected version 2018-12 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
12/23/2019 |
Dental/ ENT |
4-262 |
IEC |
80601-2-60 Edition 2.0 2019-06 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
12/23/2019 |
Orthopedic |
11-361 |
ISO |
14243-5 First edition 2019-05 |
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
06/07/2021 |
Tissue Engineering |
15-67 |
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 |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
12/21/2020 |
Sterility |
14-550 |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
06/07/2021 |
Orthopedic |
11-382 |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
06/07/2021 |
Radiology |
12-335 |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
08/06/2013 |
Materials |
8-338 |
ASTM |
F139-12 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
12/21/2020 |
Materials |
8-540 |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
08/06/2013 |
Materials |
8-339 |
ASTM |
F1091-12 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) |
01/14/2019 |
Dental/ ENT |
4-249 |
ANSI ADA |
Standard No. 19-2018 |
Elastometric Impression Materials |