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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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 General Plastic Surgery/
General Hospital		 6-401 Complete ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
01/30/2014 Physical Medicine 16-164 Complete ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
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 10-113 Complete ANSI Z80.30-2018 (R2023) American National Standard for Ophthalmics - Toric Intraocular Lenses
03/16/2012 General Plastic Surgery/
General Hospital		 6-177 Complete ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
03/16/2012 InVitro Diagnostics 7-165 Complete CLSI H20-A2 (Replaces H20-A) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/16/2012 InVitro Diagnostics 7-166 Complete CLSI GP20-A2 (Replaces GP20-A) Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
06/07/2018 General Plastic Surgery/
General Hospital		 6-270 Complete ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
08/21/2017 General Plastic Surgery/
General Hospital		 6-125 Complete ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017 General Plastic Surgery/
General Hospital		 6-400 Complete ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
12/04/2017 Software/
Informatics		 13-98 Complete ISO IEC 646 Third edition 1991-12-15 (R2018) Information technology - ISO 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991 (R2018) Information technology - ISO 7-bit coded character set for information interchange
08/21/2017 Ophthalmic 10-103 Complete ANSI Z80.18-2016 (R2021) American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
03/16/2012 InVitro Diagnostics 7-225 Complete CLSI GP34-A (Replaces GP34-P) Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
08/02/2011 InVitro Diagnostics 7-219 Complete CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
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
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/30/2014 Sterility 14-405 Complete ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
08/21/2017 Software/
Informatics		 13-95 Complete ISO IEEE 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
06/07/2021 Radiology 12-338 Complete IEC 60601-2-1 Edition 4.0 2020-10 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
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
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
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-568 Complete ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
12/19/2022 Anesthesiology 1-153 Complete NFPA 99:2021 Health Care Facilities Code
12/19/2022 Anesthesiology 1-154 Complete ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
12/21/2020 Ophthalmic 10-120 Complete ISO TR 22979 Second Edition 2017-05 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-132 Complete ASTM F623-19 Standard Performance Specification for Foley Catheter
12/20/2021 Materials 8-569 Complete ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
01/14/2019 General I (QS/
RM)		 5-120 Complete IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
08/21/2017 Software/
Informatics		 13-91 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
03/16/2012 Radiology 12-177 Complete UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
12/20/2021 General Plastic Surgery/
General Hospital		 6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
05/29/2023 Sterility 14-586 Complete ISO 22441 First edition 2022-08 Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
07/15/2019 Anesthesiology 1-116 Complete ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
07/15/2019 Anesthesiology 1-122 Complete ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
12/23/2016 Materials 8-440 Complete ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
08/21/2017 Materials 8-226 Complete ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
12/04/2017 Radiology 12-307 Complete AAMI RT2:2017 Radiation therapy readiness check
08/21/2017 Materials 8-459 Complete SAE AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Biocompatibility 2-155 Complete ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
08/21/2017 General Plastic Surgery/
General Hospital		 6-70 Complete ASTM E825-98 (Reapproved 2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/21/2017 General Plastic Surgery/
General Hospital		 6-124 Complete ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
 
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