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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
07/15/2019 Sterility 14-533 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
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
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
01/14/2019 Anesthesiology 1-114 ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
01/14/2019 Anesthesiology 1-117 ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
01/14/2019 Anesthesiology 1-120 ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
01/14/2019 Anesthesiology 1-138 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 Anesthesiology 1-141 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)]
01/14/2019 Biocompatibility 2-136 ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019 Biocompatibility 2-141 ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/14/2019 Biocompatibility 2-145 ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
01/14/2019 Biocompatibility 2-258 ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
01/14/2019 Cardiovascular 3-52 ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
01/14/2019 Cardiovascular 3-66 ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
01/14/2019 Cardiovascular 3-79 ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
01/14/2019 Cardiovascular 3-86 ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
01/14/2019 Cardiovascular 3-126 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
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)]
01/14/2019 Cardiovascular 3-138 ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
01/14/2019 Cardiovascular 3-157 ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/14/2019 Cardiovascular 3-158 ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
01/14/2019 Cardiovascular 3-159 ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
01/14/2019 Dental/
ENT
4-162 ANSI ASA S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019 Dental/
ENT
4-163 ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
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
01/14/2019 Dental/
ENT
4-217 ANSI ASA S3.36-2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
01/14/2019 Dental/
ENT
4-248 ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
01/14/2019 Dental/
ENT
4-249 ANSI ADA Standard No. 19-2018 Elastometric Impression Materials
01/14/2019 Dental/
ENT
4-250 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 ANSI ADA Standard No. 69-2017 Dental Ceramic
ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials
01/14/2019 Dental/
ENT
4-252 ANSI ADA Standard No. 48-2-2010 (R2015) LED Curing Lights
ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators
01/14/2019 Dental/
ENT
4-253 ANSI ADA Standard No. 27-2016 Polymer-based Restorative Materials
01/14/2019 Dental/
ENT
4-254 ANSI ADA Standard No. 99-2001 (R2013) Athletic Mouth Protectors and Materials
01/14/2019 Dental/
ENT
4-255 ANSI ADA Standard No. 131-2015 Dental CAD/CAM Machinable Zirconia Blanks
01/14/2019 Dental/
ENT
4-256 ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
01/14/2019 Dental/
ENT
4-257 ISO 17730 First edition 2014-11-01 Dentistry - Fluoride varnishes
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)
01/14/2019 General I (QS/
RM)
5-121 ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
01/14/2019 General I (QS/
RM)
5-122 ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
01/14/2019 General II (ES/
EMC)
19-34 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
01/14/2019 General Plastic Surgery/
General Hospital
6-338 ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
01/14/2019 General Plastic Surgery/
General Hospital
6-410 ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
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
01/14/2019 InVitro Diagnostics 7-139 CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
01/14/2019 InVitro Diagnostics 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
01/14/2019 InVitro Diagnostics 7-232 CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
01/14/2019 InVitro Diagnostics 7-269 CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 Materials 8-179 ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
01/14/2019 Materials 8-482 ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
01/14/2019 Materials 8-483 ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-485 ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
01/14/2019 Materials 8-486 ASTM F3268-18 Standard Guide for in vitro Degradation Testing of Absorbable Metals
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
01/14/2019 Materials 8-489 ASTM F3302-18 Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion
01/14/2019 Materials 8-490 ASTM F3303-18 Standard for Additive Manufacturing - Process Characteristics and Performance: Practice for Metal Powder Bed Fusion Process to Meet Critical Applications
01/14/2019 Nanotechnology 18-2 ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
01/14/2019 Nanotechnology 18-5 ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
01/14/2019 Nanotechnology 18-6 ASTM E2865-12 (Reapproved 2018) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
01/14/2019 Nanotechnology 18-7 ASTM E2834-12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
01/14/2019 Nanotechnology 18-8 ASTM E2578-07 (Reapproved 2018) 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 Nanotechnology 18-12 ISO /TS 17200 First edition 2013-06-01 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
01/14/2019 Neurology 17-14 ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-68 ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-111 ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-121 ANSI AAMI IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-122 ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods
01/14/2019 Ophthalmic 10-74 ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
01/14/2019 Ophthalmic 10-85 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 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]
01/14/2019 Ophthalmic 10-93 ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
01/14/2019 Ophthalmic 10-108 ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
01/14/2019 Ophthalmic 10-114 ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
01/14/2019 Orthopedic 11-184 ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
01/14/2019 Orthopedic 11-272 ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
01/14/2019 Orthopedic 11-343 ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
01/14/2019 Orthopedic 11-344 ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
01/14/2019 Orthopedic 11-345 ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
01/14/2019 Orthopedic 11-346 ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
01/14/2019 Orthopedic 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
01/14/2019 Orthopedic 11-348 ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
01/14/2019 Physical Medicine 16-204 ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
01/14/2019 Radiology 12-102 ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
01/14/2019 Radiology 12-321 ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
01/14/2019 Radiology 12-322 NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
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
01/14/2019 Software/
Informatics
13-79 ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
01/14/2019 Software/
Informatics
13-105 ANSI AAMI SW91:2018 Classification of defects in health software
01/14/2019 Software/
Informatics
13-106 IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019 Software/
Informatics
13-107 IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
01/14/2019 Sterility 14-314 ANSI AAMI ST67:2011/(R)2017 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
01/14/2019 Sterility 14-396 ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
01/14/2019 Sterility 14-519 ASTM F17-18 Standard Terminology Relating to Flexible Barrier Packaging
 
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