FDA-recognized standards

FDA-recognized consensus standards, one page each

The 334 standards FDA recognizes that people look up most: the horizontal ones (biocompatibility, risk, electrical safety, software, sterilization, packaging) and every standard cited by at least 5 product codes. Each page lists the recognized editions, recognition numbers, extent and dates.

Looking for one not listed here? Search all of FDA's recognitions in the Consensus Standards Lookup.

Anesthesiology

ISO 4135 Anaesthetic and respiratory equipment - Vocabulary
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
ISO 8836 Suction catheters for use in the respiratory tract
ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)]
ISO 10079-2 Medical suction equipment - Part 2: Manually powered suction equipment
ISO 10079-3 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 10079-4 Medical suction equipment - Part 4: General requirements
ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
ISO 23747 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
ISO 80369-2 Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
ISO 80601-2-55 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
ISO 80601-2-74 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Biocompatibility

ISO 10993-1 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice

Cardiovascular

AAMI TIR41 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
AAMI TIR42 Evaluation of Particulates Associated with Vascular Medical Devices
ASTM F1841 Standard Practice for Assessment of Hemolysis in Blood Pumps
ASTM F2079 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
ASTM F2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
ASTM F2394 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
ASTM F2514 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
ASTM F2606 Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
ASTM F2914 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
ASTM F2942 Standard Guide for in vitro Axial Bending and Torsional Durability Testing of Vascular Stents
ASTM F3036 Standard Guide for Testing Absorbable Stents
ASTM F3067 Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
ASTM F3505 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
IEC 80601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
ISO 5840-1 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)]
ISO 5841-3 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
ISO 11658 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 12417-1 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
ISO 18193 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
ISO 22679 Cardiovascular implants - Transcatheter cardiac occluders
ISO 25539-2 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-4 Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
ISO 27185 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels and Information to be Supplied - General Requirements
ISO 27186 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

Dental/ENT

ANSI ADA 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
ANSI ADA 47-1-2021 Stationary Dental Units and Patient Chairs-Part 1: General Requirements
ANSI ADA 47-2-2021 Stationary Dental Units and Patient Chairs-Part 2: Air Water Suction and Wastewater Systems
ANSI ADA 113-2015 Periodontal Curettes Dental Scalers and Excavators
ANSI ADA 126-2015 Casting Investments and Refractory Die Materials
ANSI ADA 135-2015 Denture Adhesives
ANSI ADA 139-2020 Dental Base Polymers
ANSI ADA 197-2021 Spoons and Bone Curettes in Dentistry
IEC 80601-2-60 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
ISO 1797 Dentistry - Shanks for rotary and oscillating instruments
ISO 3964 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7491 Dental materials - Determination of colour stability
ISO 8325 Dentistry - Test methods for rotary instruments
ISO 9168 Dentistry - Hose connectors for air driven dental handpieces
ISO 9173-1 Dentistry - Extraction forceps - Part 1: General requirements
ISO 9173-2 Dentistry - Extraction forceps - Part 2: Designation
ISO 9173-3 Dentistry - Extraction forceps - Part 3: Design
ISO 9693 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
ISO 10637 Dentistry - Central suction source equipment
ISO 10873 Dentistry - Denture adhesives
ISO 13397-1 Periodontal curettes dental scalers and excavators - Part 1: General requirements
ISO 13397-2 Dentistry - Periodontal curettes dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)]
ISO 13397-3 Periodontal curettes dental scalers and excavators - Part 3: Dental scalers - H-type
ISO 13397-5 Dentistry - Periodontal curettes dental scalers and excavators - Part 5: Jacquette scalers
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving corrosion and thermal exposure
ISO 14457 Dentistry - Handpieces and motors
ISO 15912 Dentistry - Refractory investment and die material
ISO 20795-2 Dentistry - Base polymers - Part 2: Orthodontic base polymers
ISO 21850-1 Dentistry - Materials for dental instruments - Part 1: Stainless steel
ISO 22052 Dentistry - Compressed air source equipment
ISO 22570 Dentistry - Spoons and bone curettes
ISO 27020 Dentistry - Brackets and tubes for use in orthodontics
ISO 29022 Dentistry - Adhesive - Notched-edge sheer bond strength test

General I (QS/RM)

IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8 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 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)]
ISO 18250-3 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
ISO 20417 Medical devices - Information to be supplied by the manufacturer
ISO 80369-3 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
ISO 80369-6 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

General II (ES/EMC)

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 61010-1 Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
IEC 61326-1 Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems

General Plastic Surgery/General Hospital

AAMI TIR38 Medical device safety assurance case guidance
AAMI TIR101 Fluid delivery performance testing for infusion pumps
ASTM D6355 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
ASTM D6499 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
ASTM D7103 Standard Guide for Assessment of Medical Gloves
ASTM D7866 Standard Specification for Radiation Attenuating Protective Gloves
ASTM F739 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
ASTM F1671 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 80601-2-77 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use gravity feed
ISO 10555-1 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
ISO 11608-1 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
ISO 11608-2 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
ISO 11608-3 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
ISO 11608-4 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
ISO 11608-5 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
ISO 11608-7 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
ISO 11810 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition penetration flame spread and secondary ignition
ISO 20698 Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
ISO 23908 Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods

Materials

ASTM D638 Standard Test Method for Tensile Properties of Plastics
ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM E647 Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM F603 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
ASTM F754 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
ASTM F1089 Standard Test Method for Corrosion of Surgical Instruments
ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
ASTM F1377 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075 UNS R31537 and UNS R31538)
ASTM F2024 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
ASTM F2565 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ASTM F2625 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
ASTM F2695 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
ASTM F2820 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
ASTM F3333 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
ISO 5832-3 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-4 Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 5832-5 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
ISO 5832-6 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-9 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
ISO 5832-11 Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
ISO 5832-12 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
ISO 5834-1 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
ISO 5834-2 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
ISO 5834-3 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
ISO 5834-4 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
ISO 5834-5 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
ISO 7153-1 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
ISO 11542-2 Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
ISO 13179-1 Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
ISO 13779-2 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
ISO 13779-3 Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
ISO 13779-4 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
ISO 13779-6 Implants for surgery - Hydroxyapatite - Part 6: Powders

Neurology

IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
ISO 14708-3 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

ObGyn/Gastroenterology/Urology

ASTM D7661 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
ASTM F623 Standard Performance Specification for Foley Catheter
CIE ISO 11664-1 Colorimetry - Part 1: CIE standard colorimetric observers
CIE ISO 11664-5 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u'v' uniform chromaticity scale diagram
IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ISO 8600-1 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
ISO 8600-3 Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
ISO 8600-4 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
ISO 8600-5 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
ISO 8600-6 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
ISO 8637-1 Extracorporeal systems for blood purification -- Part 1: Haemodialysers haemodiafilters haemofilters and haemoconcentrators
ISO 8637-2 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers hemodiafilters and hemofilters
ISO 20695 Enteral feeding systems - Design and testing
ISO 23500-1 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
ISO 23500-3 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ISO 23500-5 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO CIE 11664-2 Colorimetry - Part 2: CIE standard illuminants
ISO CIE 11664-3 Colorimetry - Part 3: CIE tristimulus values
ISO CIE 11664-4 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
ISO CIE 11664-6 Colorimetry - Part 6: CIEDE2000 colour-difference formula
ISO CIE 61966-2-1 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)]

Ophthalmic

IEC 80601-2-58 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
ISO 9394 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
ISO 10936-2 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
ISO 11978 Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)]
ISO 11979-1 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
ISO 11979-2 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
ISO 11979-3 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
ISO 11979-5 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
ISO 11979-6 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
ISO 11979-8 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
ISO 11981 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
ISO 11986 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
ISO 14729 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
ISO 15004-1 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
ISO 18189 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
ISO 18259 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
ISO 18369-1 Ophthalmic optics - Contact lenses - Part 1: Vocabulary classification system and recommendations for labelling specifications
ISO 18369-2 Ophthalmic optics - Contact lenses - Part 2: Tolerances
ISO 18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
ISO TR22979 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

Orthopedic

ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
ASTM F384 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F732 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F897 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
ASTM F1223 Standard Test Method for Determination of Total Knee Replacement Constraint
ASTM F1357 Standard Specification for Articulating Total Wrist Implants
ASTM F1378 Standard Specification for Shoulder Prostheses
ASTM F1714 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F1800 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components
ASTM F1820 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
ASTM F1829 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
ASTM F1875 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
ASTM F2028 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
ASTM F2033 Standard Specification for Hip Joint Replacement Bearing Surfaces
ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices
ASTM F2267 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2345 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
ASTM F2381 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
ASTM F2385 Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
ASTM F2580 Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
ASTM F2582 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
ASTM F2777 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
ASTM F2887 Standard Specification for Total Elbow Prostheses
ASTM F2979 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
ASTM F2996 Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
ASTM F3018 Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement
ASTM F3047 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
ASTM F3090 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
ASTM F3141 Standard Guide for Total Knee Replacement Loading Profiles
ASTM F3143 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3161 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
ASTM F3210 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
ASTM F3292 Standard Practice for Inspection of Spinal Implants Undergoing Testing
ASTM F3334 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
ASTM F3446 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
ASTM F3631 Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
ASTM F3738 Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles
ISO 7206-2 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic ceramic and plastics materials [Including AMENDMENT1 (2016) ]
ISO 7206-4 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
ISO 7206-6 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
ISO 7206-10 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
ISO 7206-12 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components
ISO 7206-13 Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
ISO 7207-1 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification definitions and designation of dimensions
ISO 7207-2 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal ceramic and plastics materials
ISO 11491 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
ISO 14242-1 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
ISO 14242-2 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
ISO 14242-3 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
ISO 14242-4 Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
ISO 14243-1 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
ISO 14243-2 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14243-3 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
ISO 14243-5 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
ISO 14879-1 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
ISO 16087 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
ISO 21535 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
ISO 21536 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
ISO 23089-2 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices

Physical Medicine

IEC 80601-2-78 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation assessment compensation or alleviation
ISO 7176 Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
ISO 7176-1 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5 Wheelchairs - Part 5: Determination of overall dimensions mass and manoeuvring space
ISO 7176-6 Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
ISO 7176-7 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static impact and fatigue strengths
ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11 Wheelchairs - Part 11: Test dummies
ISO 7176-13 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15 Wheelchairs - Part 15: Requirements for information disclosure documentation and labeling
ISO 7176-19 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
ISO 7176-21 Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters and battery chargers
ISO 7176-22 Wheelchairs - Part 22: Set-up procedures
ISO 10328 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
ISO 16840-10 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method

Radiology

IEC 60601-2-1 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-11 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment
IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring cosmetic and aesthetic use
IEC 60731 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
IEC 61161 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
IEC 61217 Radiotherapy equipment - Coordinates movements and scales
IEC 61223-3-8 Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
IEC 61674 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
IEC 61910-1 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
IEC 62083 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
IEC 62359 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
IEC 62471 Photobiological safety of lamps and lamp systems
IEEE 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
ISO 4090 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications

Software/Informatics

AAMI TIR57 Principles for medical device security - Risk management.
IEC 62304 Medical device software - Software life cycle processes
IEC 81001-5-1 Health software and health IT systems safety effectiveness and security - Part 5-1: Security - Activities in the product life cycle
IEEE 11073-10103 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device cardiac
IEEE 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE 11073-10406-2023 Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE 11073-10417-2015 Health Informatics - Personal Health Device Communication Part 10417: Device Specialization - Glucose Meter
IEEE 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
IEEE 11073-10419 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
IEEE 11073-10422-2016 Health informatics - Personal health device communication Part 10422: Device Specialization - Urine Analyzer
ISO 11073-91064 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
ISO IEEE 11073-10102 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG

Sterility

AAMI TIR17 Compatibility of materials subjected to sterilization
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes [Including Amendment 1 (2023)].
ISO 11737-1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process
ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01.