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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Number and Date
 

Title of Standard
 
 
09/17/2018 General I (QS/
RM)
5-42 ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
12/19/2022 General I (QS/
RM)
5-137 IEC /TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice
12/19/2022 General I (QS/
RM)
5-136 ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
07/06/2020 General I (QS/
RM)
5-126 ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
12/19/2022 General I (QS/
RM)
5-139 ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/19/2022 General I (QS/
RM)
5-141 ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
12/19/2022 General I (QS/
RM)
5-135 ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
12/19/2022 General I (QS/
RM)
5-138 AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/20/2021 General I (QS/
RM)
5-134 ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/19/2022 General I (QS/
RM)
5-140 ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
06/27/2016 General I (QS/
RM)
5-108 ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
12/21/2020 General I (QS/
RM)
5-132 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 General I (QS/
RM)
5-133 ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
12/21/2020 General I (QS/
RM)
5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 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 [Including Amendment 2 (2021)]
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 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
06/27/2016 General I (QS/
RM)
5-89 IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
07/06/2020 General I (QS/
RM)
5-130 ISO 7010 Third edition 2019-07 Graphical symbols - Safety colours and safety signs - Registered safety signs
06/27/2016 General I (QS/
RM)
5-57 ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
09/17/2018 General II (ES/
EMC)
19-8 ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
09/17/2018 General II (ES/
EMC)
19-19 IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
12/21/2020 General II (ES/
EMC)
19-38 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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
06/27/2016 General II (ES/
EMC)
19-14 IEC 60601-1-11 Edition 2.0 2015-01 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
12/20/2021 General II (ES/
EMC)
19-42 IEC 61326-1 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/20/2021 General II (ES/
EMC)
19-43 IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
07/09/2014 General II (ES/
EMC)
19-9 IEC 60601-1-10 Edition 1.1 2013-11 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
12/21/2020 General II (ES/
EMC)
19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
12/21/2020 General II (ES/
EMC)
19-37 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
06/27/2016 General II (ES/
EMC)
19-15 ANSI AAMI IEC 60601-1-12:2016 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency
IEC 60601-1-12 Edition 1.0 2014-06 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
06/07/2021 General II (ES/
EMC)
19-40 IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
05/30/2022 General II (ES/
EMC)
19-47 ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
04/04/2016 General II (ES/
EMC)
19-16 ANSI AAMI HA60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
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)]
12/20/2021 General II (ES/
EMC)
19-44 ANSI IEEE C63.24-2021 American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
02/07/2022 General II (ES/
EMC)
19-45 AIM Standard 7351731 Rev. 3.00 2021-06-04 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
09/17/2018 General II (ES/
EMC)
19-30 AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
04/03/2023 General II (ES/
EMC)
19-49 IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 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.
12/19/2022 General II (ES/
EMC)
19-48 ANSI IEEE USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
09/17/2018 General II (ES/
EMC)
19-31 ANSI IEEE C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
04/04/2016 General II (ES/
EMC)
19-17 ANSI IEEE C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
04/03/2023 General II (ES/
EMC)
19-34 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION 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
08/21/2017 General II (ES/
EMC)
19-24 IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017 General II (ES/
EMC)
19-26 IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017 General II (ES/
EMC)
19-28 IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
12/20/2021 General II (ES/
EMC)
19-41 ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
07/09/2014 General II (ES/
EMC)
19-10 UL 1642 5th Edition Lithium Batteries
12/23/2019 General II (ES/
EMC)
19-13 IEC 62133 Edition 2.0 2012-12 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 [Including: Corrigendum 1 (2013)]
08/21/2017 General II (ES/
EMC)
19-22 AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
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)
12/21/2020 General II (ES/
EMC)
19-39 ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]
IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
07/09/2014 General II (ES/
EMC)
19-11 UL 2054 2nd Edition Household and Commercial Batteries
12/23/2019 General II (ES/
EMC)
19-32 IEC 62133-1 Edition 1.0 2017-02 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 1: Nickel systems
12/23/2019 General II (ES/
EMC)
19-33 IEC 62133-2 Edition1.0 2017-02 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
08/21/2017 General II (ES/
EMC)
19-25 IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-27 IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
08/21/2017 General II (ES/
EMC)
19-29 ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
12/23/2016 General II (ES/
EMC)
19-20 ANSI IEEE C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
07/15/2019 General II (ES/
EMC)
19-35 UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
08/06/2013 General Plastic Surgery/
General Hospital
6-179 ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
06/07/2018 General Plastic Surgery/
General Hospital
6-407 ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
12/23/2019 General Plastic Surgery/
General Hospital
6-426 ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
12/23/2019 General Plastic Surgery/
General Hospital
6-427 ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
07/15/2019 General Plastic Surgery/
General Hospital
6-422 AAMI TIR38:2019 Medical device safety assurance case guidance
07/15/2019 General Plastic Surgery/
General Hospital
6-421 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
01/14/2019 General Plastic Surgery/
General Hospital
6-410 ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
12/23/2019 General Plastic Surgery/
General Hospital
6-424 ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
12/23/2019 General Plastic Surgery/
General Hospital
6-425 ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
08/06/2013 General Plastic Surgery/
General Hospital
6-296 ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
08/21/2017 General Plastic Surgery/
General Hospital
6-388 ANSI AAMI IEC 60601-2-21:2009/A1:2016 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
08/21/2017 General Plastic Surgery/
General Hospital
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
05/30/2022 General Plastic Surgery/
General Hospital
6-482 AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
07/06/2020 General Plastic Surgery/
General Hospital
6-447 ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
09/17/2018 General Plastic Surgery/
General Hospital
6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses
09/21/2016 General Plastic Surgery/
General Hospital
6-382 ISO 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
04/04/2016 General Plastic Surgery/
General Hospital
6-356 ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
12/20/2021 General Plastic Surgery/
General Hospital
6-470 USP-NF M99660_03_01 <871> Sutures - Needle Attachment
07/15/2019 General Plastic Surgery/
General Hospital
6-129 ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
06/07/2018 General Plastic Surgery/
General Hospital
6-214 ASTM D6355-07 (Reapproved 2017) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
04/04/2016 General Plastic Surgery/
General Hospital
6-355 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
09/21/2016 General Plastic Surgery/
General Hospital
6-379 ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
01/14/2019 General Plastic Surgery/
General Hospital
6-338 ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves
01/30/2014 General Plastic Surgery/
General Hospital
6-306 ASTM F1671/F1671M-13 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
12/20/2021 General Plastic Surgery/
General Hospital
6-471 USP-NF M88880_05_01 Sterile Water for Irrigation
04/04/2016 General Plastic Surgery/
General Hospital
6-357 ISO 10555-6 First edition 2015-04-15 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
01/30/2014 General Plastic Surgery/
General Hospital
6-322 ISO 10555-4 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
03/16/2012 General Plastic Surgery/
General Hospital
6-272 ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
07/06/2020 General Plastic Surgery/
General Hospital
6-439 ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
07/06/2020 General Plastic Surgery/
General Hospital
6-441 ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
07/06/2020 General Plastic Surgery/
General Hospital
6-444 ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
08/06/2013 General Plastic Surgery/
General Hospital
6-295 ANSI AAMI BF7:2012 Blood transfusion microfilters
09/21/2016 General Plastic Surgery/
General Hospital
6-380 ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
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 General Plastic Surgery/
General Hospital
6-110 ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices
06/07/2018 General Plastic Surgery/
General Hospital
6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
05/30/2022 General Plastic Surgery/
General Hospital
6-478 ISO 11608-1:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
06/07/2018 General Plastic Surgery/
General Hospital
6-404 ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
03/18/2009 General Plastic Surgery/
General Hospital
6-215 ASTM F2132-01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
08/06/2013 General Plastic Surgery/
General Hospital
6-216 ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
01/30/2014 General Plastic Surgery/
General Hospital
6-253 ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons - Requirements and test methods
03/16/2012 General Plastic Surgery/
General Hospital
6-268 ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
06/07/2018 General Plastic Surgery/
General Hospital
6-401 ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
06/07/2018 General Plastic Surgery/
General Hospital
6-270 ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
 
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