|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 12/23/2016 |
Orthopedic |
11-319 |
ISO |
7206-12 First edition 2016-10-01 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
| 12/21/2020 |
Materials |
8-553 |
ASTM ISO |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 01/30/2014 |
Sterility |
14-430 |
ASTM ISO |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
| 01/14/2019 |
Materials |
8-487 |
ASTM ISO |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
| 01/14/2019 |
Materials |
8-488 |
ASTM |
F3301-18a |
Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion |
| 12/23/2016 |
Biocompatibility |
2-245 |
ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 06/07/2018 |
Tissue Engineering |
15-54 |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| 07/06/2020 |
Radiology |
12-330 |
NEMA |
Standards Publication XR 28-2018 |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 12/19/2022 |
Materials |
8-595 |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 08/14/2015 |
Anesthesiology |
1-105 |
ISO |
80601-2-72 First edition 2015-04-11 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-115 |
ISO |
29943-1 First edition 2017-07. |
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-119 |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
| 12/20/2021 |
Dental/
ENT |
4-288 |
ANSI ADA |
Standard No. 43-2020 |
Electrically Powered Dental Amalgamators |
| ISO |
7488 Second edition 2018-04 |
Dentistry - Mixing machines for dental amalgam |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-465 |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 05/30/2022 |
Materials |
8-588 |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 12/23/2019 |
Dental/
ENT |
4-260 |
ANSI ASA |
S12.2-2019 |
American National Standard Criteria for Evaluating Room Noise |
| 08/06/2013 |
Software/
Informatics |
13-55 |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 12/23/2019 |
Materials |
8-501 |
ISO |
5834-1 Fourth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
| 06/07/2018 |
Biocompatibility |
2-250 |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
| 06/27/2016 |
Radiology |
12-293 |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 03/16/2012 |
Anesthesiology |
1-75 |
ANSI AAMI ISO |
5362:2006 |
Anaesthetic Reservoir Bags |
| ISO |
5362 Fourth edition 2006-06-01 |
Anaesthetic Reservoir Bags |
| 06/07/2018 |
Anesthesiology |
1-129 |
ISO |
5359 Fourth edition 2014-10-01 |
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] |
| 12/23/2019 |
Materials |
8-492 |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| 12/23/2019 |
Materials |
8-494 |
ISO |
6474-1 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
| 12/23/2019 |
Materials |
8-498 |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 12/23/2019 |
Materials |
8-499 |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| 12/23/2019 |
Materials |
8-500 |
ISO |
5832-12 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
| 07/15/2019 |
Software/
Informatics |
13-108 |
IEEE |
Std 11073-20701-2018 |
Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-67 |
ASTM |
D7661-10 (Reapproved 2017) |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| 09/17/2018 |
Cardiovascular |
3-153 |
ASTM |
F2743-11 |
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
| 09/17/2018 |
InVitro Diagnostics |
7-284 |
CLSI |
EP37 1st Edition |
Supplemental Tables for Interference Testing in Clinical Chemistry |
| 09/17/2018 |
InVitro Diagnostics |
7-277 |
CLSI |
GP41 7th Edition |
Collection of Diagnostic Venous Blood Specimens |
| 09/17/2018 |
InVitro Diagnostics |
7-278 |
CLSI |
M27 4th Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
| 09/17/2018 |
InVitro Diagnostics |
7-279 |
CLSI |
M07 11th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| 09/17/2018 |
InVitro Diagnostics |
7-280 |
CLSI |
M02 13th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
| 07/06/2020 |
Tissue Engineering |
15-63 |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| 07/06/2020 |
Orthopedic |
11-365 |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| 07/06/2020 |
Orthopedic |
11-366 |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 07/06/2020 |
Materials |
8-527 |
ASTM |
F899-20 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-426 |
ISO |
23907-1 First edition 2019-01 |
Sharps injury protection - Requirements and test methods - Sharps containers |
| 01/30/2014 |
Dental/
ENT |
4-153 |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 01/30/2014 |
Dental/
ENT |
4-180 |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 01/30/2014 |
Dental/
ENT |
4-188 |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 01/27/2015 |
Sterility |
14-243 |
ISO |
14644-6 First edition 2007-07-15 |
Cleanrooms and associated controlled environments - Part 6: Vocabulary |
| 06/27/2016 |
Radiology |
12-298 |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
| 01/15/2013 |
Software/
Informatics |
13-34 |
ANSI AAMI IEC |
TIR80002-1:2009 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| IEC |
TR 80002-1 Edition 1.0 2009-09 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| 12/23/2016 |
Software/
Informatics |
13-87 |
IEC ISO |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
| 12/23/2016 |
Anesthesiology |
1-119 |
ISO |
14408 Third edition 2016-02-15 |
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information |
| 01/30/2014 |
Materials |
8-157 |
ISO |
9583 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
| 07/09/2014 |
Sterility |
14-437 |
ASTM ISO |
52701 First edition 2013-11-15 (R2020) |
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| 04/04/2016 |
Materials |
8-401 |
ASTM |
F2118-14 (Reapproved 2020) |
Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
| 05/30/2022 |
Materials |
8-591 |
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) |
| 07/09/2014 |
Radiology |
12-282 |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
ASTM |
F881-94 (Reapproved 2014) |
Standard Specification for Silicone Elastomer Facial Implants |
| 04/04/2016 |
General II (ES/
EMC) |
19-17 |
ANSI IEEE |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| 12/04/2017 |
Software/
Informatics |
13-103 |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
| 04/04/2016 |
Physical Medicine |
16-196 |
ISO |
7176-7 First Edition 1998-05-15 |
Wheelchairs - Part 7: Measurement of seating and wheel dimensions |
| 04/04/2016 |
Physical Medicine |
16-197 |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| 04/04/2016 |
Physical Medicine |
16-198 |
ISO |
7176-22 Second edition 2014-09-01 |
Wheelchairs - Part 22: Set-up procedures |
| 04/04/2016 |
Tissue Engineering |
15-24 |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
| 08/06/2013 |
Software/
Informatics |
13-59 |
IEC IEEE ISO |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
| 08/21/2017 |
Orthopedic |
11-242 |
ASTM |
F1839-08 (Reapproved 2016) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 07/09/2014 |
Materials |
8-379 |
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)] |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-382 |
ISO |
11608-7 First edition 2016-08-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-363 |
ISO |
11810 Second edition 2015-12-15 |
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
| 08/06/2013 |
Materials |
8-158 |
ASTM |
F1713-08 (Reapproved 2013) |
Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
| 04/04/2016 |
Orthopedic |
11-301 |
ASTM |
F2091-15 |
Standard Specification for Acetabular Prostheses |
| 04/04/2016 |
Physical Medicine |
16-195 |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
| 04/04/2016 |
Radiology |
12-188 |
NEMA |
MS-1-2008 (R2020) |
Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging |
| 04/04/2016 |
Radiology |
12-187 |
NEMA |
MS 3-2008 (R2020) |
Determination of Image Uniformity in Diagnostic Magnetic Resonance Images |
| 09/17/2018 |
Orthopedic |
11-338 |
ISO |
11491 First edition 2017-07 |
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
| 07/09/2014 |
Sterility |
14-432 |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
| 06/27/2016 |
Dental/
ENT |
4-202 |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 01/30/2014 |
Physical Medicine |
16-167 |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
| 01/30/2014 |
Radiology |
12-262 |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
| 07/09/2014 |
InVitro Diagnostics |
7-48 |
CLSI |
C60-A |
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
| 07/09/2014 |
InVitro Diagnostics |
7-221 |
CLSI |
GP39-A6 (Formerly H01-A6) |
Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition |
| 01/27/2015 |
Sterility |
14-166 |
ISO |
14644-7 First edition 2004-10-01 |
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| 09/17/2018 |
Orthopedic |
11-341 |
ASTM |
F3140-17 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-117 |
ISO |
16038 Second edition 2017-11 |
Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-120 |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
| 03/16/2012 |
Cardiovascular |
3-96 |
ANSI AAMI ISO |
81060-1:2007/(R)2013 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
| ISO |
81060-1 First edition 2007-12-01 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
| 12/19/2007 |
Radiology |
12-176 |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| 09/09/2008 |
Software/
Informatics |
13-12 |
CLSI |
AUTO4-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
| 03/16/2012 |
Ophthalmic |
10-70 |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 03/16/2012 |
Radiology |
12-117 |
ISO |
15367-1 First edition 2003-09-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects |
| 06/07/2018 |
Sterility |
14-510 |
ANSI AAMI ISO |
11137-3:2017 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO |
11137-3 Second edition 2017-06 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 09/09/2008 |
Sterility |
14-191 |
ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
| ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
| 09/17/2018 |
Tissue Engineering |
15-55 |
ASTM |
F3259-17 |
Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds |
| 12/20/2021 |
Orthopedic |
11-391 |
ASTM |
F2722 - 21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| 12/23/2016 |
General II (ES/
EMC) |
19-20 |
ANSI IEEE |
C63.16-2016 (Revision of ANSI C63.16-1993) |
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment |
| 07/09/2014 |
Software/
Informatics |
13-65 |
ANSI UL |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
| 08/06/2013 |
Software/
Informatics |
13-57 |
IEEE ISO |
11073-10407 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| 01/27/2015 |
Sterility |
14-389 |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
| 01/27/2015 |
Sterility |
14-390 |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
| 08/21/2017 |
General II (ES/
EMC) |
19-22 |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
| 01/30/2014 |
Orthopedic |
11-74 |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
| 09/09/2008 |
Sterility |
14-240 |
ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
| ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
| 04/04/2016 |
Sterility |
14-277 |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
| ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
| 08/06/2013 |
Sterility |
14-388 |
ANSI AAMI ISO |
13408-7:2012 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
| ISO |
13408-7 First edition 2012-08-01 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
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