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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2016 Materials 8-441 Complete ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
08/21/2017 Materials 8-453 Complete ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
12/20/2021 Materials 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
01/14/2019 Materials 8-482 Complete ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
05/30/2022 Materials 8-592 Complete ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
01/14/2019 Materials 8-179 Partial ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
04/04/2016 Materials 8-409 Partial ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
12/21/2020 Materials 8-543 Partial ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
12/23/2016 Materials 8-439 Partial ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
06/07/2018 Nanotechnology 18-9 Complete 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)].
08/14/2015 Nanotechnology 18-4 Complete ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
01/14/2019 Nanotechnology 18-8 Complete ASTM E2578-07 (Reapproved 2022) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
06/07/2018 Nanotechnology 18-10 Complete 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 18-7 Complete ASTM E2834-12 (Reapproved 2022) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
01/14/2019 Nanotechnology 18-5 Complete ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
04/04/2016 Nanotechnology 18-1 Complete ASTM E2490-09 (Reapproved 2021) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
01/14/2019 Nanotechnology 18-11 Complete ISO /TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
12/21/2020 Nanotechnology 18-18 Complete ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
07/06/2020 Nanotechnology 18-16 Complete ISO /TS 21362 First edition 2018-06 Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
01/14/2019 Nanotechnology 18-6 Complete ASTM E2865-12 (Reapproved 2022) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
12/21/2020 Nanotechnology 18-17 Complete ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
12/20/2021 Nanotechnology 18-19 Complete ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
12/20/2021 Nanotechnology 18-20 Complete ASTM E3275-21 Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
12/19/2022 Nanotechnology 18-22 Complete ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
01/14/2019 Nanotechnology 18-12 Complete ISO /TS 17200 First edition 2013-06-01 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
01/14/2019 Nanotechnology 18-2 Partial ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
01/27/2015 Nanotechnology 18-3 Partial ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
12/19/2022 Nanotechnology 18-21 Complete ISO /TS 80004-6 Second edition 2021-03 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
07/15/2019 Nanotechnology 18-14 Partial ISO /TR 11360 First edition 2010-07-15 Nanotechnologies - Methodology for the classification and categorization of nanomaterials
07/15/2019 Nanotechnology 18-13 Partial 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
05/29/2023 Nanotechnology 18-23 Complete ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
07/06/2020 Nanotechnology 18-15 Complete ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
01/14/2019 Neurology 17-14 Complete ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
01/30/2014 Neurology 17-12 Complete ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
12/21/2020 Neurology 17-17 Complete ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
01/27/2015 Neurology 17-13 Complete IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
06/07/2018 Neurology 17-15 Complete ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
06/07/2018 Neurology 17-16 Complete 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
06/07/2018 Neurology 17-1 Partial AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
08/14/2015 Neurology 17-4 Partial ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-132 Complete ASTM F623-19 Standard Performance Specification for Foley Catheter
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-86 Complete ISO 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 Complete ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-116 Complete ISO 29943-2 First edition 2017-07 Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-115 Complete ISO 29943-1 First edition 2017-07. Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports
08/14/2015 ObGyn/
Gastroenterology/
Urology		 9-108 Complete ISO 8009 Second edition 2014-11-15 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-148 Complete ISO CIE 11664-6 Second edition 2022-08 Colorimetry - Part 6: CIEDE2000 colour-difference formula
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-128 Complete ISO CIE 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-147 Complete ISO CIE 11664-2 First edition 2022-08 Colorimetry - Part 2: CIE standard illuminants
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 Complete 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
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-125 Complete ISO CIE 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 Colorimetry - Part 2: CIE standard illuminants
08/06/2013 ObGyn/
Gastroenterology/
Urology		 9-31 Complete ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-88 Complete ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-85 Complete ASTM D6976-13R18 Standard Specification for Rubber Contraceptives - Vaginal Diaphragms
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-138 Complete ISO 20695 First edition 2020-03 Enteral feeding systems - Design and testing
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-126 Complete ISO CIE 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-129 Complete ISO CIE 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)]
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-124 Complete CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
04/04/2016 ObGyn/
Gastroenterology/
Urology		 9-110 Complete ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-127 Complete ISO CIE 11664-4 First edition 2019-06 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
12/21/2020 ObGyn/
Gastroenterology/
Urology		 9-130 Complete ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-121 Complete 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
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-120 Complete ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-135 Complete 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 Complete 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
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-131 Complete 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
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-134 Complete 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
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-137 Complete 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
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 Complete 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 Complete ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-117 Complete ISO 16038 Second edition 2017-11 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
09/09/2008 ObGyn/
Gastroenterology/
Urology		 9-7 Complete IEC 61846 First edition 1998-04 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-144 Complete ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use
04/04/2016 ObGyn/
Gastroenterology/
Urology		 9-113 Complete CEN EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-114 Complete 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
05/30/2022 ObGyn/
Gastroenterology/
Urology		 9-139 Complete CIE ISO 11664-5:2016 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-146 Complete ISO 8600-4 Third Edition 2023-01 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
07/09/2014 ObGyn/
Gastroenterology/
Urology		 9-94 Complete ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-141 Complete ISO 8637-3 First Edition 2018-07 Extracorporeal systems for blood purification - Part 3: Plasmafilters
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-67 Complete ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-143 Partial ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-140 Partial ANSI AAMI ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ISO 8637-2 First Edition 2018-07 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-89 Partial ANSI AAMI ISO 8638:2010 (R2015) Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
ISO 8638 Third edition 2010-07-01 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialyzers, haemodiafilters, and haemofilters
12/23/2019 ObGyn/
Gastroenterology/
Urology		 9-123 Partial 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.
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-118 Partial 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
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-133 Partial 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
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-142 Complete ASTM D1894-14 Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
10/17/2014 ObGyn/
Gastroenterology/
Urology		 9-95 Partial CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-145 Complete ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-122 Complete ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods
12/19/2007 Ophthalmic 10-39 Complete ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
09/21/2016 Ophthalmic 10-101 Complete 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
06/07/2018 Ophthalmic 10-109 Complete 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 Complete ISO 11979-10 First edition 2006-08-15 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]
12/20/2021 Ophthalmic 10-127 Complete ANSI Z80.21-2020 American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
08/02/2011 Ophthalmic 10-65 Complete ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
12/19/2022 Ophthalmic 10-133 Complete ISO 11979-10 Second edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
12/20/2021 Ophthalmic 10-129 Complete ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
 
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