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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
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
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
01/30/2014 Materials 8-159 ISO 9584 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
01/30/2014 Materials 8-218 ASTM F799-11 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
01/30/2014 Materials 8-344 ISO 7153-1 Second edition 1991-04-01 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
01/30/2014 Materials 8-346 ASTM F1813-13 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
01/30/2014 Materials 8-347 ASTM F2146-13 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
01/30/2014 Materials 8-348 ASTM F138-13 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
01/30/2014 Materials 8-353 ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
01/30/2014 Materials 8-354 ASTM F1377-13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
01/30/2014 Materials 8-355 ASTM F1586/F1586M-13 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
01/30/2014 Materials 8-358 ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
01/30/2014 Materials 8-362 ASTM F2989-13 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
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)]
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-85 ASTM D6976-13R18 Standard Specification for Rubber Contraceptives - Vaginal Diaphragms
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-86 ISO 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-88 ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-89 ANSI AAMI ISO 8638:2010/(R)2015 Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
ISO 8638 Third edition 2010-07-01 Cadiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters
01/30/2014 Ophthalmic 10-87 ASTM D882-12 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
01/30/2014 Ophthalmic 10-88 ASTM D790-10 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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
01/30/2014 Orthopedic 11-75 ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
01/30/2014 Orthopedic 11-83 ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
01/30/2014 Orthopedic 11-232 ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
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
01/30/2014 Orthopedic 11-264 ASTM F1820-13 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
01/30/2014 Orthopedic 11-274 ISO 18192-2 First edition 2010-06-15 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
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
01/30/2014 Physical Medicine 16-27 ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
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
01/30/2014 Physical Medicine 16-163 ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
01/30/2014 Physical Medicine 16-164 ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
01/30/2014 Physical Medicine 16-165 ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
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 12-59 IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-228 IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
01/30/2014 Radiology 12-259 IEC 61674 Edition 2.0 2012-11 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
01/30/2014 Radiology 12-261 IEC ISO 10918-1 First edition 1994-02-15 Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
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)]
01/30/2014 Radiology 12-264 NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
01/30/2014 Radiology 12-266 IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
01/30/2014 Radiology 12-267 IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
01/30/2014 Radiology 12-270 IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
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
01/30/2014 Sterility 14-334 ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
01/30/2014 Sterility 14-336 ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
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
01/30/2014 Sterility 14-399 AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 ASTM F2203-13 (Reapproved 2018) Standard Test Method for Linear Measurement Using Precision Steel Rule
01/30/2014 Sterility 14-401 ASTM F2217/F2217M-13 (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
01/30/2014 Sterility 14-402 ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-404 ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/30/2014 Sterility 14-405 ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
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
01/30/2014 Sterility 14-424 ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-429 ASTM ISO 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/14/2014 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
01/14/2014 Radiology 12-269 IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
08/06/2013 Cardiovascular 3-87 ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
08/06/2013 Cardiovascular 3-115 IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
08/06/2013 Cardiovascular 3-116 ANSI AAMI ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2 Second edition 2012-12-01 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
08/06/2013 Dental/
ENT		 4-90 ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
08/06/2013 Dental/
ENT		 4-167 ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
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)
08/06/2013 General I (QS/
RM)		 5-76 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 Medical Electrical Equipment ¿ Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
08/06/2013 General Plastic Surgery/
General Hospital		 6-147 ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
08/06/2013 General Plastic Surgery/
General Hospital		 6-174 ISO 11608-4 First edition 2006-03-15 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
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
08/06/2013 General Plastic Surgery/
General Hospital		 6-216 ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
08/06/2013 General Plastic Surgery/
General Hospital		 6-240 ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
08/06/2013 General Plastic Surgery/
General Hospital		 6-275 ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
08/06/2013 General Plastic Surgery/
General Hospital		 6-276 ISO 8536-1 Fourth edition 2011-09-01 Infusion equipment for medical use - Part 1: Infusion glass bottles
08/06/2013 General Plastic Surgery/
General Hospital		 6-294 ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
08/06/2013 General Plastic Surgery/
General Hospital		 6-295 ANSI AAMI BF7:2012 Blood transfusion microfilters
08/06/2013 General Plastic Surgery/
General Hospital		 6-296 ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
08/06/2013 InVitro Diagnostics 7-234 CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
08/06/2013 InVitro Diagnostics 7-243 CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
08/06/2013 Materials 8-153 ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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)
08/06/2013 Materials 8-336 ASTM F562-13 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
08/06/2013 Materials 8-338 ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
08/06/2013 Materials 8-339 ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
08/06/2013 Materials 8-342 ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
08/06/2013 Materials 8-343 ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments
08/06/2013 ObGyn/
Gastroenterology/
Urology		 9-31 ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
08/06/2013 Ophthalmic 10-77 ISO 9394 Third edition 2012-10-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
08/06/2013 Ophthalmic 10-78 ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
08/06/2013 Orthopedic 11-252 ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
08/06/2013 Orthopedic 11-254 ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
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
08/06/2013 Physical Medicine 16-192 ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes
 
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