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U.S. Department of Health and Human Services

Recognized Consensus Standards
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07/09/2014 InVitro Diagnostics 7-48 CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
07/09/2014 InVitro Diagnostics 7-175 CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
07/09/2014 InVitro Diagnostics 7-213 CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
07/09/2014 InVitro Diagnostics 7-221 CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
07/09/2014 Materials 8-374 ASTM F2633-13 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/09/2014 Materials 8-377 ASTM F136-13 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
07/09/2014 Materials 8-378 ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
07/09/2014 Materials 8-379 ISO 11542-2 First edition 1998-11-15 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)]
07/09/2014 ObGyn/
Gastroenterology/
Urology		 9-94 ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
07/09/2014 Orthopedic 11-276 ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
07/09/2014 Orthopedic 11-277 ISO 7206-6 Second edition 2013-11-15 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
07/09/2014 Radiology 12-194 ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
07/09/2014 Radiology 12-272 IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
07/09/2014 Radiology 12-273 IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
07/09/2014 Radiology 12-275 IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014 Radiology 12-277 IEC 62127-1 Edition 1.1 2013-02 Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-279 IEC 62127-03 Edition 1.1 2013-05 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-280 IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
07/09/2014 Radiology 12-281 IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/09/2014 Radiology 12-282 ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
07/09/2014 Radiology 12-283 ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
07/09/2014 Software/
Informatics		 13-15 CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
07/09/2014 Software/
Informatics		 13-65 ANSI UL 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
07/09/2014 Software/
Informatics		 13-68 ISO 11073-90101 First edition 2008-01-15 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
07/09/2014 Software/
Informatics		 13-69 IEEE ISO 11073-10472 First edition 2012-11-01 Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor
07/09/2014 Sterility 14-256 ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
07/09/2014 Sterility 14-257 ASTM D3078-02 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
07/09/2014 Sterility 14-282 ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
07/09/2014 Sterility 14-290 ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
07/09/2014 Sterility 14-432 ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
07/09/2014 Sterility 14-433 ASTM F2227-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
07/09/2014 Sterility 14-434 ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-435 ASTM F2251-13 (Reapproved 2018) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-437 ASTM ISO 52701 First edition 2013-11-15 (R2020) Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
07/09/2014 Tissue Engineering 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
10/17/2014 ObGyn/
Gastroenterology/
Urology		 9-95 CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
01/27/2015 Dental/
ENT		 4-136 ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/27/2015 Dental/
ENT		 4-185 ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
01/27/2015 Dental/
ENT		 4-218 ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
01/27/2015 Dental/
ENT		 4-219 ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
01/27/2015 General I (QS/
RM)		 5-48 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 ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
01/27/2015 InVitro Diagnostics 7-250 CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
01/27/2015 Materials 8-171 ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/27/2015 Materials 8-383 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 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 IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 ASTM F2528-06 (Reapproved 2014) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
01/27/2015 Ophthalmic 10-91 ISO 11979-10 First edition 2006-08-15 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]
01/27/2015 Orthopedic 11-281 ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
01/27/2015 Orthopedic 11-283 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 NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-285 IEC 60601-2-1 Edition 3.1 2014-07 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
01/27/2015 Radiology 12-286 NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
01/27/2015 Radiology 12-287 NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
01/27/2015 Software/
Informatics		 13-70 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 RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
01/27/2015 Software/
Informatics		 13-72 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 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 ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
01/27/2015 Sterility 14-166 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 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
01/27/2015 Sterility 14-243 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015 Sterility 14-379 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 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 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 ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
08/14/2015 Anesthesiology 1-103 ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment -- Breathing sets and connectors
08/14/2015 Anesthesiology 1-105 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 ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
08/14/2015 Dental/
ENT		 4-184 ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
08/14/2015 Dental/
ENT		 4-220 ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 General I (QS/
RM)		 5-97 ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 80369-20 First edition 2015-05-15 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 ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices
08/14/2015 General Plastic Surgery/
General Hospital		 6-185 ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 ASTM E1061-01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
08/14/2015 General Plastic Surgery/
General Hospital		 6-341 ISO 11608-1 Third edition 2014-12-15 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
08/14/2015 General Plastic Surgery/
General Hospital		 6-353 ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015 General Plastic Surgery/
General Hospital		 6-354 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 CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-253 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 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 CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015 Materials 8-389 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 Nanotechnology 18-4 ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
08/14/2015 Neurology 17-4 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 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 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 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 ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
08/14/2015 Ophthalmic 10-97 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 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 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 ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
08/14/2015 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
08/14/2015 Orthopedic 11-294 ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
08/14/2015 Physical Medicine 16-194 ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
 
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