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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 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
06/07/2018 Tissue Engineering 15-51 ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Tissue Engineering 15-52 ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
06/07/2018 Tissue Engineering 15-54 ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
12/04/2017 Radiology 12-307 AAMI RT2:2017 Radiation therapy readiness check
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
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
12/04/2017 Software/
Informatics
13-100 IEC ISO 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
12/04/2017 Software/
Informatics
13-101 IEC ISO 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
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
12/04/2017 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
08/21/2017 Anesthesiology 1-124 ISO 8835-7 First edition 2011-11-01 Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
08/21/2017 Anesthesiology 1-127 ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
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
08/21/2017 Biocompatibility 2-246 ASTM F1877-16 Standard Practice for Characterization of Particles
08/21/2017 Biocompatibility 2-247 ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
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
08/21/2017 Cardiovascular 3-149 ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
08/21/2017 Dental/
ENT
4-215 ANSI ADA Standard No. 96-2012 Dental Water-based Cements
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 Dental/
ENT
4-232 ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
08/21/2017 Dental/
ENT
4-233 ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/21/2017 Dental/
ENT
4-234 ANSI ADA Standard No. 139-2012 Dental Base Polymers
08/21/2017 Dental/
ENT
4-236 ANSI ADA Standard No. 119-2015 Manual Toothbrushes
08/21/2017 Dental/
ENT
4-238 ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
08/21/2017 Dental/
ENT
4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
08/21/2017 General I (QS/
RM)
5-107 ANSI AAMI ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
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.
08/21/2017 General II (ES/
EMC)
19-24 IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
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)
19-26 IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
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
08/21/2017 General II (ES/
EMC)
19-28 IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
08/21/2017 General II (ES/
EMC)
19-29 ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
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 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
6-384 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
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
08/21/2017 General Plastic Surgery/
General Hospital
6-386 ANSI AAMI IEC 60601-2-20:2009/A1:2016 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)]
IEC 60601-2-20 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
08/21/2017 General Plastic Surgery/
General Hospital
6-387 ANSI AAMI IEC 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
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)]
08/21/2017 General Plastic Surgery/
General Hospital
6-390 ANSI AAMI IEC 80601-2-35:2009/A1:2016 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
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 InVitro Diagnostics 7-270 CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/21/2017 InVitro Diagnostics 7-272 CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
08/21/2017 InVitro Diagnostics 7-273 CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
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
08/21/2017 Materials 8-226 ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
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 Materials 8-428 ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
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
08/21/2017 Materials 8-449 ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
08/21/2017 Materials 8-451 ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
08/21/2017 Materials 8-452 ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
08/21/2017 Materials 8-453 ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
08/21/2017 Materials 8-455 ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
08/21/2017 Materials 8-457 ISO 13175-3 First edition 2012-10-01 Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
08/21/2017 Materials 8-458 ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
08/21/2017 Materials 8-459 SAE /AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Ophthalmic 10-103 ANSI Z80.18-2016 (R2021) American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
08/21/2017 Ophthalmic 10-104 ANSI Z80.20-2016 (R2021) American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
08/21/2017 Orthopedic 11-175 ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
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
08/21/2017 Orthopedic 11-269 ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
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 11-309 ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
08/21/2017 Orthopedic 11-321 ASTM F2887-17 Standard Specification for Total Elbow Prostheses
08/21/2017 Radiology 12-306 NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
08/21/2017 Software/
Informatics
13-67 IEEE ISO 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
08/21/2017 Software/
Informatics
13-88 IEEE ISO 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
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 Software/
Informatics
13-90 IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
08/21/2017 Software/
Informatics
13-91 IEEE ISO 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
08/21/2017 Software/
Informatics
13-92 IEEE ISO 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/21/2017 Software/
Informatics
13-93 IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Software/
Informatics
13-94 IEEE ISO 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/21/2017 Software/
Informatics
13-95 IEEE ISO 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
08/21/2017 Software/
Informatics
13-96 ANSI UL 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/21/2017 Software/
Informatics
13-97 IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
08/21/2017 Sterility 14-502 ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
08/21/2017 Tissue Engineering 15-49 ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
12/23/2016 Anesthesiology 1-118 ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
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
12/23/2016 Biocompatibility 2-93 ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
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
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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
12/23/2016 Cardiovascular 3-144 ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
12/23/2016 General I (QS/
RM)
5-113 ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
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)]
12/23/2016 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
12/23/2016 InVitro Diagnostics 7-267 CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
12/23/2016 InVitro Diagnostics 7-268 CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
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
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 8-437 ASTM F2082/F2082M-16 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
 
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