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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 Radiology 12-314 ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
01/30/2014 Physical Medicine 16-25 ISO 7176-13 First edition 1989-08-01 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
01/27/2015 Sterility 14-456 ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO /TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
12/23/2016 Software/
Informatics		 13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
01/30/2014 Physical Medicine 16-162 ISO 7176-4 Third edition 2008-10-01 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
04/04/2016 Materials 8-393 ASTM F1350-15 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
04/04/2016 Materials 8-399 ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
01/30/2014 General Plastic Surgery/
General Hospital		 6-273 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 ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
03/16/2012 General Plastic Surgery/
General Hospital		 6-272 ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
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
12/20/2021 Orthopedic 11-392 ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
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)
09/17/2018 InVitro Diagnostics 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 Orthopedic 11-337 ISO 16087 First edition 2013-10-01 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
09/17/2018 Orthopedic 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
06/07/2021 Dental/
ENT		 4-282 ANSI ADA Standard No. 135-2015 Denture Adhesives
ISO 10873 First edition 2010-09 Dentistry - Denture adhesives
12/20/2021 Dental/
ENT		 4-285 ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
12/20/2021 Cardiovascular 3-178 ASTM F3067 - 14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
04/04/2016 Dental/
ENT		 4-224 ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
08/14/2015 Ophthalmic 10-98 ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015 Ophthalmic 10-97 ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
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
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
06/07/2018 Radiology 12-308 IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
08/21/2017 Materials 8-195 ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
04/04/2016 Materials 8-200 ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
08/21/2017 Materials 8-447 ISO 5832-3 Fourth edition 2016-10-15 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
09/17/2018 Biocompatibility 2-256 ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
09/17/2018 Materials 8-465 ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018 Materials 8-112 ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
09/17/2018 Materials 8-466 ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
06/07/2018 Software/
Informatics		 13-104 ANSI UL 2900-2-1 First Edition 2017 Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
12/23/2016 Sterility 14-169 ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
04/04/2016 Materials 8-405 ISO 5832-4 Third edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
12/23/2016 Materials 8-435 ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
12/23/2016 Materials 8-368 ASTM F2625-10 (Reapproved 2016) Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
01/30/2014 Sterility 14-395 ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Sterility 14-397 AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/14/2019 Orthopedic 11-343 ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
01/30/2014 Orthopedic 11-239 ASTM F2345-03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
01/27/2015 Orthopedic 11-283 ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
12/23/2016 Sterility 14-500 ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
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.
07/09/2014 Dental/
ENT		 4-165 ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
07/09/2014 Dental/
ENT		 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-88 ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods
04/04/2016 Radiology 12-196 NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
07/09/2014 General II (ES/
EMC)		 19-11 UL 2054 2nd Edition Household and Commercial Batteries
08/06/2013 Physical Medicine 16-190 ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
08/06/2013 Physical Medicine 16-191 ISO 7176-16 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
08/21/2017 Dental/
ENT		 4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
08/06/2013 Dental/
ENT		 4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
04/04/2016 Tissue Engineering 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
01/30/2014 Dental/
ENT		 4-198 ANSI ADA Standard No.30-2013 (R2018) Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements
ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
06/27/2016 Materials 8-431 ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
01/30/2014 Sterility 14-412 AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
01/30/2014 Sterility 14-413 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
08/14/2015 Radiology 12-289 IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
07/09/2014 Radiology 12-279 IEC 62127-03 Edition 1.1 2013-05 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
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 InVitro Diagnostics 7-251 CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
01/14/2014 Radiology 12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
04/04/2016 Materials 8-135 ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
01/27/2015 Materials 8-383 ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
12/23/2016 Materials 8-442 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
12/23/2016 Materials 8-444 ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
12/23/2016 InVitro Diagnostics 7-267 CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
01/27/2015 Software/
Informatics		 13-72 IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
08/14/2015 Dental/
ENT		 4-130 ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
07/09/2014 Anesthesiology 1-99 ASTM G175-13 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
04/04/2016 Physical Medicine 16-198 ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
01/27/2015 General I (QS/
RM)		 5-48 ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
01/27/2015 General I (QS/
RM)		 5-62 ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
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
09/17/2018 InVitro Diagnostics 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
01/30/2014 General Plastic Surgery/
General Hospital		 6-306 ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
08/21/2017 Software/
Informatics		 13-97 IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
03/31/2006 Anesthesiology 1-67 NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
03/31/2006 Radiology 12-136 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
03/31/2006 Radiology 12-137 ISO 4090 Third eidition 2001-08-15 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
03/31/2006 Radiology 12-138 ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
10/04/2004 Radiology 12-116 ISO 13696:2002 Optics and optical instruments -- Test methods for radiation scattered by optical components
03/31/2006 Radiology 12-141 IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
01/30/2014 General I (QS/
RM)		 5-47 ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
04/04/2016 General Plastic Surgery/
General Hospital		 6-355 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
01/27/2015 Radiology 12-230 NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-286 NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
09/17/2018 Materials 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
04/04/2016 Materials 8-404 ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016 Materials 8-406 ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
04/04/2016 ObGyn/
Gastroenterology/
Urology		 9-110 ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
07/06/2020 Orthopedic 11-363 ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
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
 
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