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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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06/07/2018 Dental/
ENT		 4-241 Complete ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
06/07/2018 General Plastic Surgery/
General Hospital		 6-214 Complete ASTM D6355-07(2022) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital		 6-270 Complete ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
06/07/2018 General Plastic Surgery/
General Hospital		 6-401 Complete ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital		 6-402 Complete ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
06/07/2018 General Plastic Surgery/
General Hospital		 6-404 Complete ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 Complete IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
06/07/2018 General Plastic Surgery/
General Hospital		 6-406 Complete ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
06/07/2018 General Plastic Surgery/
General Hospital		 6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
06/07/2018 Materials 8-113 Complete ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
06/07/2018 Materials 8-337 Complete ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants
06/07/2018 Materials 8-356 Complete ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
06/07/2018 Materials 8-463 Complete ISO ASTM 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
06/07/2018 Materials 8-464 Complete ISO TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
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)].
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.
06/07/2018 Neurology 17-1 Partial AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
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 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
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
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 Ophthalmic 10-105 Complete ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
06/07/2018 Ophthalmic 10-106 Complete ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-107 Complete ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
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
06/07/2018 Physical Medicine 16-201 Complete ISO 7176-19 Second Edition 2008-07-15 Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
06/07/2018 Radiology 12-313 Complete IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
06/07/2018 Radiology 12-314 Complete ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
06/07/2018 Radiology 12-315 Complete NEMA MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
06/07/2018 Radiology 12-316 Complete IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
06/07/2018 Software/
Informatics		 13-104 Complete UL ANSI 2900-2-1 First Edition 2017 Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
06/07/2018 Sterility 14-510 Complete 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
ANSI AAMI ISO 11137-3:2017/(R)2023 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 Complete 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 Complete 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 Complete ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
09/17/2018 Anesthesiology 1-139 Partial ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
09/17/2018 Anesthesiology 1-140 Complete ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
09/17/2018 Cardiovascular 3-110 Complete AAMI TIR 41:2011/(R)2017 Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
09/17/2018 Cardiovascular 3-153 Complete ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018 Cardiovascular 3-154 Complete ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
09/17/2018 Cardiovascular 3-156 Complete ISO 14708-1 Second edition 2014-08-15 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ANSI AAMI ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018 Dental/
ENT		 4-242 Complete ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
09/17/2018 Dental/
ENT		 4-244 Complete ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
09/17/2018 Dental/
ENT		 4-246 Complete ISO 20749 First edition 2017-03 Dentistry - Pre-capsulated dental amalgam
ANSI ADA Standard No. 144-2018 Alloy for Dental Amalgam
09/17/2018 Dental/
ENT		 4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
09/17/2018 General I (QS/
RM)		 5-42 Complete ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
09/17/2018 General II (ES/
EMC)		 19-19 Partial IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
09/17/2018 General II (ES/
EMC)		 19-31 Complete IEEE ANSI C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
09/17/2018 General Plastic Surgery/
General Hospital		 6-123 Complete ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
09/17/2018 General Plastic Surgery/
General Hospital		 6-408 Partial ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
09/17/2018 General Plastic Surgery/
General Hospital		 6-409 Complete ASTM F703-18 Standard Specification for Implantable Breast Prostheses
09/17/2018 InVitro Diagnostics 7-275 Complete CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 Complete CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 InVitro Diagnostics 7-277 Complete CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-278 Complete CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 Complete CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
09/17/2018 InVitro Diagnostics 7-283 Complete CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 Materials 8-112 Complete ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
09/17/2018 Materials 8-380 Complete ASTM F1160-14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
09/17/2018 Materials 8-412 Complete ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
09/17/2018 Materials 8-465 Complete ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018 Materials 8-466 Complete ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
09/17/2018 Materials 8-467 Complete ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
09/17/2018 Materials 8-468 Complete ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
09/17/2018 Materials 8-470 Complete ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
09/17/2018 Materials 8-472 Complete ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
09/17/2018 Materials 8-474 Complete ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
09/17/2018 Materials 8-475 Complete ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
09/17/2018 Materials 8-476 Complete ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
09/17/2018 Materials 8-478 Complete ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
09/17/2018 Materials 8-479 Complete ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
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
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
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-118 Partial ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI AAMI ISO 8637-1:2017 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-120 Complete ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
09/17/2018 Ophthalmic 10-56 Partial ANSI Z80.12-2007 (R2022) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
09/17/2018 Ophthalmic 10-57 Complete ANSI Z80.13-2007 (R2022) American National Standard for Ophthalmics - Phakic Intraocular Lenses
09/17/2018 Ophthalmic 10-84 Complete ANSI Z80.11-2012 (R2022) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
09/17/2018 Ophthalmic 10-111 Complete 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 Complete 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 10-113 Complete ANSI Z80.30-2018 (R2023) American National Standard for Ophthalmics - Toric Intraocular Lenses
09/17/2018 Orthopedic 11-185 Complete ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-199 Complete ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
09/17/2018 Orthopedic 11-310 Complete ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
09/17/2018 Orthopedic 11-324 Complete ASTM F366-17 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
09/17/2018 Orthopedic 11-326 Complete ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-327 Complete ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
09/17/2018 Orthopedic 11-329 Complete ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
 
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