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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
08/06/2013 ObGyn/
Gastroenterology/
Urology
9-31 ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors
08/14/2015 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
01/30/2014 General Plastic Surgery/
General Hospital
6-303 ISO 10555-5 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/27/2015 Sterility 14-243 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
06/07/2021 Dental/
ENT
4-281 ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
12/19/2022 Radiology 12-347 IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
07/15/2019 Biocompatibility 2-266 ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
09/09/2008 Software/
Informatics
13-24 CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
05/05/2010 InVitro Diagnostics 7-205 CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
05/05/2010 InVitro Diagnostics 7-207 CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
10/04/2010 Radiology 12-215 IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/14/2011 Radiology 12-217 IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
10/04/2010 InVitro Diagnostics 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
01/14/2019 ObGyn/
Gastroenterology/
Urology
9-122 ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods
12/20/2021 Materials 8-563 ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
03/16/2012 Radiology 12-106 ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012 Radiology 12-246 ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012 Radiology 12-245 ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
08/20/2012 General Plastic Surgery/
General Hospital
6-242 ISO 8536-2 Third edition 2010-03-15 Infusion equipment for medical use - Part 2: Closures for infusion bottles
01/15/2013 Sterility 14-359 ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
03/16/2012 General Plastic Surgery/
General Hospital
6-269 ASTM F1078-10 (Reapproved 2018) Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
03/16/2012 General Plastic Surgery/
General Hospital
6-271 ASTM F1874-98 (Reapproved 2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
05/30/2022 General Plastic Surgery/
General Hospital
6-477 ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022 General Plastic Surgery/
General Hospital
6-475 ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
08/02/2011 InVitro Diagnostics 7-219 CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/02/2011 Ophthalmic 10-65 ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
01/15/2013 Software/
Informatics
13-33 AAMI TIR 36:2007 Validation of software for regulated processes
01/15/2013 General Plastic Surgery/
General Hospital
6-122 ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
03/16/2012 InVitro Diagnostics 7-227 CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/15/2013 InVitro Diagnostics 7-233 CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-235 CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
12/23/2019 Anesthesiology 1-145 ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
12/23/2019 General Plastic Surgery/
General Hospital
6-437 ISO 23907-2 First edition 2019-11 Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-128 CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
12/20/2021 Materials 8-564 ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
12/20/2021 Materials 8-565 ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
12/23/2016 Anesthesiology 1-119 ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
01/30/2014 Materials 8-157 ISO 9583 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
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
04/04/2016 Materials 8-401 ASTM F2118-14 (Reapproved 2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
04/04/2016 Materials 8-135 ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
06/07/2018 Ophthalmic 10-107 ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
08/06/2013 Radiology 12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
06/07/2021 Materials 8-556 ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
12/19/2022 Dental/
ENT
4-295 ANSI ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
01/30/2014 General Plastic Surgery/
General Hospital
6-305 ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014 Orthopedic 11-232 ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
09/21/2016 Ophthalmic 10-101 ISO 18189 First edition 2016-06-01 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
12/23/2016 Orthopedic 11-311 ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
03/31/2006 Radiology 12-141 IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
12/23/2016 Tissue Engineering 15-48 ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
12/20/2021 Dental/
ENT
4-289 ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
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
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 14-434 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
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/14/2019 Materials 8-487 ASTM ISO 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
12/21/2020 Orthopedic 11-371 ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
12/21/2020 Orthopedic 11-372 ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
06/07/2021 Sterility 14-562 ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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
12/23/2016 Orthopedic 11-319 ISO 7206-12 First edition 2016-10-01 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
06/27/2016 Materials 8-432 ASTM ISO 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016 Materials 8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
12/20/2021 Dental/
ENT
4-290 ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
12/20/2021 Dental/
ENT
4-291 ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
12/19/2022 ObGyn/
Gastroenterology/
Urology
9-144 ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use
12/19/2022 Orthopedic 11-395 ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
06/27/2016 Orthopedic 11-306 ASTM F1814-15 Standard Guide for Evaluating Modular Hip and Knee Joint Components
01/14/2019 Software/
Informatics
13-106 IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
05/30/2022 Ophthalmic 10-131 ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
04/04/2016 Sterility 14-340 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
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
05/30/2022 General Plastic Surgery/
General Hospital
6-476 ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
01/14/2019 Materials 8-485 ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
12/20/2021 Sterility 14-563 ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
01/30/2014 InVitro Diagnostics 7-152 CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
08/21/2017 Materials 8-451 ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
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
01/30/2014 Radiology 12-266 IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
01/30/2014 Sterility 14-400 ASTM F2203-13 (Reapproved 2022) Standard Test Method for Linear Measurement Using Precision Steel Rule
06/27/2016 Radiology 12-298 NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
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
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 InVitro Diagnostics 7-257 CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
01/30/2014 Physical Medicine 16-164 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 ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
09/17/2018 Ophthalmic 10-113 ANSI Z80.30-2018 American National Standard for Ophthalmics - Toric Intraocular Lenses
05/30/2022 Dental/
ENT
4-293 ANSI ADA Standard No. 119-2021 Manual Toothbrushes
08/21/2017 Dental/
ENT
4-236 ANSI ADA Standard No. 119-2015 Manual Toothbrushes
08/14/2015 Sterility 14-478 ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
05/30/2022 Radiology 12-344 IEC 62563-2 Edition 1.0 2021-11 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
01/30/2014 Cardiovascular 3-54 ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
04/04/2016 Physical Medicine 16-196 ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
04/04/2016 Physical Medicine 16-197 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 ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
05/30/2022 General II (ES/
EMC)
19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
07/09/2014 General II (ES/
EMC)
19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
08/21/2017 General Plastic Surgery/
General Hospital
6-390 ANSI AAMI IEC 80601-2-35:2009/A1:2016 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
 
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