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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date
 

Title of Standard
 
 
12/21/2020 Dental/
ENT
4-266 ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
12/21/2020 Dental/
ENT
4-267 ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
12/21/2020 Dental/
ENT
4-268 ANSI ADA Standard No. 32-2017 Orthodontic Wires
ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
12/21/2020 Dental/
ENT
4-269 ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
12/21/2020 Dental/
ENT
4-270 ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
12/21/2020 Dental/
ENT
4-271 ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/21/2020 Dental/
ENT
4-272 ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
12/21/2020 General I (QS/
RM)
5-131 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
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 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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