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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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04/04/2016 Orthopedic 11-303 Complete ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
04/04/2016 Orthopedic 11-304 Complete ASTM F3107-14 Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
04/04/2016 Physical Medicine 16-195 Complete ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
04/04/2016 Physical Medicine 16-196 Complete ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
04/04/2016 Physical Medicine 16-197 Complete ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
04/04/2016 Physical Medicine 16-198 Complete ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
04/04/2016 Radiology 12-187 Complete NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
04/04/2016 Radiology 12-188 Complete NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016 Radiology 12-195 Complete NEMA MS 6-2008 (R2014, R2020) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
04/04/2016 Radiology 12-196 Complete NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
04/04/2016 Radiology 12-288 Complete NEMA MS 9-2008 (R2020) Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
04/04/2016 Software/
Informatics
13-81 Complete IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
04/04/2016 Sterility 14-277 Complete ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
04/04/2016 Sterility 14-340 Complete ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016 Tissue Engineering 15-24 Complete ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
04/04/2016 Tissue Engineering 15-43 Complete ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
04/04/2016 Tissue Engineering 15-44 Partial ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
08/14/2015 Anesthesiology 1-103 Partial ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment - Breathing sets and connectors
08/14/2015 Anesthesiology 1-105 Complete ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/14/2015 Dental/
ENT
4-130 Complete ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
08/14/2015 Dental/
ENT
4-184 Complete ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
08/14/2015 Dental/
ENT
4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 General I (QS/
RM)
5-97 Complete ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015 General Plastic Surgery/
General Hospital
6-110 Complete ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices
08/14/2015 General Plastic Surgery/
General Hospital
6-185 Complete ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
08/14/2015 General Plastic Surgery/
General Hospital
6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
08/14/2015 General Plastic Surgery/
General Hospital
6-353 Complete ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015 General Plastic Surgery/
General Hospital
6-354 Complete ASTM D7907-14 (Reapproved 2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
08/14/2015 InVitro Diagnostics 7-251 Complete CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-252 Complete CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-253 Complete CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-255 Partial CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015 Materials 8-389 Complete ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical 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
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
08/14/2015 Ophthalmic 10-94 Complete ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/14/2015 Ophthalmic 10-95 Complete ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
08/14/2015 Ophthalmic 10-96 Partial ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
08/14/2015 Ophthalmic 10-97 Complete ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
08/14/2015 Ophthalmic 10-98 Complete ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015 Ophthalmic 10-99 Complete 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
08/14/2015 Orthopedic 11-183 Complete ASTM F1875-98 (Reapproved 2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
08/14/2015 Orthopedic 11-290 Complete ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
08/14/2015 Orthopedic 11-294 Complete ASTM F1357-14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
08/14/2015 Physical Medicine 16-194 Complete ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
08/14/2015 Radiology 12-289 Complete IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
08/14/2015 Radiology 12-290 Complete IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
08/14/2015 Radiology 12-291 Complete IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
08/14/2015 Radiology 12-292 Complete IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
08/14/2015 Software/
Informatics
13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
08/14/2015 Software/
Informatics
13-74 Complete IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/14/2015 Software/
Informatics
13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015 Software/
Informatics
13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
08/14/2015 Software/
Informatics
13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/14/2015 Software/
Informatics
13-78 Complete INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
08/14/2015 Sterility 14-460 Partial ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
08/14/2015 Sterility 14-463 Complete ISO ASTM 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
08/14/2015 Sterility 14-464 Complete ISO ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/14/2015 Sterility 14-465 Complete ISO ASTM 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
06/27/2015 Sterility 14-484 Complete ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
01/27/2015 Dental/
ENT
4-136 Complete ASTM F2504-05 (Reapproved 2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/27/2015 Dental/
ENT
4-185 Complete ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
01/27/2015 Dental/
ENT
4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
01/27/2015 Dental/
ENT
4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
01/27/2015 General I (QS/
RM)
5-48 Complete ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
01/27/2015 General I (QS/
RM)
5-62 Complete ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
01/27/2015 Materials 8-171 Complete ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/27/2015 Materials 8-383 Complete ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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
01/27/2015 Neurology 17-13 Complete IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
01/27/2015 ObGyn/
Gastroenterology/
Urology
9-45 Complete ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
01/27/2015 Orthopedic 11-281 Complete ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
01/27/2015 Orthopedic 11-283 Complete ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
01/27/2015 Radiology 12-230 Complete NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-286 Complete NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
01/27/2015 Software/
Informatics
13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
01/27/2015 Software/
Informatics
13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
01/27/2015 Software/
Informatics
13-72 Complete IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
01/27/2015 Sterility 14-165 Complete ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
01/27/2015 Sterility 14-242 Complete ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
01/27/2015 Sterility 14-243 Complete ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
01/27/2015 Sterility 14-389 Complete ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
01/27/2015 Sterility 14-456 Complete ISO /TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
07/09/2014 Anesthesiology 1-99 Complete ASTM G175-13 (Reapproved 2021) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
07/09/2014 Anesthesiology 1-101 Complete CGA C-9:2013 Standard Color Marking of Compressed Gas Containers for Medical Use
07/09/2014 Dental/
ENT
4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
07/09/2014 Dental/
ENT
4-149 Complete ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
07/09/2014 Dental/
ENT
4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
07/09/2014 Dental/
ENT
4-165 Complete ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
07/09/2014 Dental/
ENT
4-177 Complete ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
 
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