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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
06/07/2018 General Plastic Surgery/
General Hospital
6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
09/17/2018 Materials 8-469 ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
12/23/2016 Orthopedic 11-312 ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
01/27/2015 Sterility 14-379 ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
08/14/2015 Sterility 14-464 ASTM ISO 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
06/07/2021 Materials 8-560 ASTM D1415-18 Standard Test Method for Rubber Property - International Hardness
12/23/2019 General Plastic Surgery/
General Hospital
6-427 ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
07/06/2020 Cardiovascular 3-165 ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
07/06/2020 Cardiovascular 3-155 ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
12/23/2016 Materials 8-440 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
08/21/2017 Dental/
ENT
4-215 ANSI ADA Standard No. 96-2012 Dental Water-based Cements
08/21/2017 Materials 8-226 ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
12/04/2017 Radiology 12-307 AAMI RT2:2017 Radiation therapy readiness check
08/21/2017 Materials 8-459 SAE /AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Biocompatibility 2-155 ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
01/14/2019 General Plastic Surgery/
General Hospital
6-411 ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/21/2020 Dental/
ENT
4-269 ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
12/20/2021 Dental/
ENT
4-284 ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/19/2022 ObGyn/
Gastroenterology/
Urology
9-144 ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use
01/14/2019 General I (QS/
RM)
5-120 IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
04/04/2016 Radiology 12-195 NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
06/07/2018 ObGyn/
Gastroenterology/
Urology
9-116 ISO 29943-2 First edition 2017-07 Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
06/07/2018 Dental/
ENT
4-241 ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
12/20/2021 General Plastic Surgery/
General Hospital
6-469 USP-NF M99650_02_01 <861> Sutures - Diameter
04/04/2016 Ophthalmic 10-100 ISO 18259 First Edition 2014-10-01 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
12/04/2017 Software/
Informatics
13-102 IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
12/20/2021 General Plastic Surgery/
General Hospital
6-470 USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 Materials 8-566 ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
01/27/2015 Dental/
ENT
4-136 ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
07/09/2014 Dental/
ENT
4-149 ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
06/27/2016 Dental/
ENT
4-86 ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
06/27/2016 Dental/
ENT
4-227 ANSI ADA Standard No. 134-2018 Metallic Materials for Fixed and Removable Restorations and Appliances
ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances
01/14/2019 Orthopedic 11-344 ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
12/04/2017 Software/
Informatics
13-98 IEC INCITS ISO 646 Third edition 1991-12-15 (R2018) Information technology - IS0 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991[R2018] Information technology - IS0 7-bit coded character set for information interchange
04/04/2016 Sterility 14-337 ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
12/20/2021 General Plastic Surgery/
General Hospital
6-466 USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital
6-467 USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-468 USP-NF M99670_02_01 <881> Tensile Strength
01/14/2019 Orthopedic 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
12/04/2017 Software/
Informatics
13-99 IEC ISO 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
05/30/2022 Materials 8-587 ISO 5832-3 Fifth Edition 2021-11 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
09/17/2018 Cardiovascular 3-110 AAMI TIR 41:2011/(R)2017 Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
08/21/2017 General II (ES/
EMC)
19-25 IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-27 IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
04/04/2016 Nanotechnology 18-1 ASTM E2490-09 (Reapproved 2021) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
06/07/2018 General Plastic Surgery/
General Hospital
6-407 ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
06/07/2018 Cardiovascular 3-150 ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
06/07/2018 Materials 8-463 ASTM ISO 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
01/14/2019 Tissue Engineering 15-47 ISO 22442-3 First edition 2007-12-15 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
01/14/2019 Dental/
ENT
4-171 ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
12/20/2021 Orthopedic 11-386 ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 General Plastic Surgery/
General Hospital
6-464 ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
04/04/2016 Orthopedic 11-303 ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
01/27/2015 Materials 8-171 ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
12/23/2016 Software/
Informatics
13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
08/21/2017 Orthopedic 11-280 ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
08/21/2017 Orthopedic 11-321 ASTM F2887-17 Standard Specification for Total Elbow Prostheses
01/30/2014 Materials 8-123 ISO 5832-5 Third edition 2005-10-15 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
12/20/2021 Dental/
ENT
4-289 ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
12/23/2016 Biocompatibility 2-94 ASTM F981-04 (Reapproved 2016) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
01/30/2014 Software/
Informatics
13-63 ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
08/21/2017 Software/
Informatics
13-89 IEEE ISO 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
08/21/2017 Dental/
ENT
4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/14/2019 Biocompatibility 2-141 ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
08/14/2015 Dental/
ENT
4-220 ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 Ophthalmic 10-94 ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/21/2017 Biocompatibility 2-248 ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
12/23/2019 Physical Medicine 16-222 ANSI RESNA 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
12/23/2019 Physical Medicine 16-223 ANSI RESNA 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
05/27/2005 Radiology 12-121 IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
07/09/2014 Dental/
ENT
4-160 ANSI ASA S3.1-1999 (Reaffirmed 2018) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
12/23/2016 General I (QS/
RM)
5-113 ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
08/21/2017 Dental/
ENT
4-231 ANSI ADA Standard No. 111-2019 Adhesion Test Methods to Tooth Structure
ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth structure
08/21/2017 General Plastic Surgery/
General Hospital
6-70 ASTM E825-98 (Reapproved 2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/21/2017 General Plastic Surgery/
General Hospital
6-124 ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 Materials 8-333 ASTM F2393-12 (Reapproved 2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
08/21/2017 General Plastic Surgery/
General Hospital
6-384 ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017 General Plastic Surgery/
General Hospital
6-125 ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017 General Plastic Surgery/
General Hospital
6-400 ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
08/21/2017 Anesthesiology 1-127 ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
12/21/2020 Biocompatibility 2-280 ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
01/27/2015 Sterility 14-165 ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
07/09/2014 Sterility 14-257 ASTM D3078-02 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
08/06/2013 Sterility 14-383 ASTM ISO 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
03/16/2012 General Plastic Surgery/
General Hospital
6-272 ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
01/30/2014 Neurology 17-12 ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
09/17/2018 Dental/
ENT
4-247 ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
01/14/2019 Radiology 12-321 ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
12/21/2020 Dental/
ENT
4-270 ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
07/15/2019 Sterility 14-528 ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
01/14/2019 Nanotechnology 18-5 ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
07/15/2019 Anesthesiology 1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
07/06/2020 Orthopedic 11-367 ISO 14243-3 Second edition 2014-11-01 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020 Orthopedic 11-368 ASTM F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
08/06/2013 Materials 8-343 ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments
 
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