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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/23/2019 Materials 8-480 ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
12/23/2019 Materials 8-481 ASTM F1314-18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
12/23/2019 Materials 8-484 ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
12/21/2020 Materials 8-544 ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
07/06/2020 Nanotechnology 18-16 ISO /TS 21362 First edition 2018-06 Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
12/21/2020 Nanotechnology 18-17 ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
01/14/2019 Nanotechnology 18-12 ISO /TS 17200 First edition 2013-06-01 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
07/15/2019 Nanotechnology 18-13 ISO /TS 18827 First edition 2017-06 Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
01/14/2019 Nanotechnology 18-2 ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
01/27/2015 Nanotechnology 18-3 ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
07/15/2019 Nanotechnology 18-14 ISO /TR 11360 First edition 2010-07-15 Nanotechnologies - Methodology for the classification and categorization of nanomaterials
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
12/20/2021 Nanotechnology 18-19 ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
06/07/2018 Nanotechnology 18-9 ISO /TR 13014 First edition 2012-05-15 Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
06/07/2018 Nanotechnology 18-10 ISO 29701 First edition 2010-09-15 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
01/14/2019 Nanotechnology 18-5 ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
04/04/2016 Nanotechnology 18-1 ASTM E2490-09 (Reapproved 2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
12/20/2021 Nanotechnology 18-20 ASTM E3275-21 Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
08/14/2015 Nanotechnology 18-4 ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
01/14/2019 Nanotechnology 18-11 ISO /TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
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
07/06/2020 Nanotechnology 18-15 ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
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)
06/07/2018 Neurology 17-15 ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
06/07/2018 Neurology 17-16 IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
01/14/2019 Neurology 17-14 ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
01/27/2015 Neurology 17-13 IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
12/21/2020 Neurology 17-17 ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
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)]
06/07/2018 Neurology 17-1 AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
08/14/2015 Neurology 17-4 ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-118 ANSI AAMI ISO 8637-1:2017 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
12/23/2019 ObGyn/
Gastroenterology/
Urology
9-123 ISO 8600-3 Second edition 2019-08 Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
10/17/2014 ObGyn/
Gastroenterology/
Urology
9-95 CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
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
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-122 ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-132 ASTM F623-19 Standard Performance Specification for Foley Catheter
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-133 ANSI AAMI ISO 23500-1:2019 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
ISO 23500-1 First edition 2019-02 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
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
07/09/2014 ObGyn/
Gastroenterology/
Urology
9-94 ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
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)]
09/09/2008 ObGyn/
Gastroenterology/
Urology
9-7 IEC 61846 First edition 1998-04 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-67 ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
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.
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
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-128 CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/30/2022 ObGyn/
Gastroenterology/
Urology
9-139 CIE ISO 11664-5:2016 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
06/07/2018 ObGyn/
Gastroenterology/
Urology
9-115 ISO 29943-1 First edition 2017-07. Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-117 ISO 16038 Second edition 2017-11 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
06/07/2018 ObGyn/
Gastroenterology/
Urology
9-114 IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-135 ANSI AAMI ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ISO 23500-3 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-136 ANSI AAMI ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-4 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
08/06/2013 ObGyn/
Gastroenterology/
Urology
9-31 ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-134 ANSI AAMI ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-2 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
01/27/2015 ObGyn/
Gastroenterology/
Urology
9-45 ASTM F2528-06 (Reapproved 2014) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-129 CIE ISO 61966-2-1 First edition 1999-10 Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
01/30/2014 ObGyn/
Gastroenterology/
Urology
9-88 ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-120 ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
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
08/14/2015 ObGyn/
Gastroenterology/
Urology
9-108 ISO 8009 Second edition 2014-11-15 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-138 ISO 20695 First edition 2020-03 Enteral feeding systems - Design and testing
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-125 CIE ISO 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 Colorimetry - Part 2: CIE standard illuminants
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-127 CIE ISO 11664-4 First edition 2019-06 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-126 CIE ISO 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-124 CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-131 ISO 8600-5 Second Edition 2020-10 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
12/21/2020 ObGyn/
Gastroenterology/
Urology
9-130 ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-137 ANSI AAMI ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-5 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
04/04/2016 ObGyn/
Gastroenterology/
Urology
9-113 CEN EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
12/21/2020 Ophthalmic 10-119 ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
07/15/2019 Ophthalmic 10-117 ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
12/21/2020 Ophthalmic 10-121 ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
12/19/2007 Ophthalmic 10-37 ISO 10942 Second edition 2006-06-01 Ophthalmic instruments - Direct ophthalmoscopes
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
09/17/2018 Ophthalmic 10-111 ISO 11981 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
09/17/2018 Ophthalmic 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
09/17/2018 Ophthalmic 10-57 ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics - Phakic Intraocular Lenses
06/07/2018 Ophthalmic 10-109 ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
01/27/2015 Ophthalmic 10-91 ISO 11979-10 First edition 2006-08-15 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]
03/16/2012 Ophthalmic 10-70 ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
06/07/2018 Ophthalmic 10-105 ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
06/07/2018 Ophthalmic 10-106 ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-107 ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
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
08/02/2011 Ophthalmic 10-65 ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
09/17/2018 Ophthalmic 10-113 ANSI Z80.30-2018 American National Standard for Ophthalmics - Toric Intraocular Lenses
09/21/2016 Ophthalmic 10-101 ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
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
08/14/2015 Ophthalmic 10-99 ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
01/30/2014 Ophthalmic 10-87 ASTM D882-12 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
05/30/2022 Ophthalmic 10-131 ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
12/20/2021 Ophthalmic 10-128 ASTM D882-18 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
12/19/2007 Ophthalmic 10-39 ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
06/07/2018 Ophthalmic 10-110 ISO 15798 Third edition 2013-09-15 Ophthalmic implants - Ophthalmic viscosurgical devices [Including: Amendment 1 (2017)]
 
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