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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 4-221
ISO  7494-2 Second edition 2015-04-01
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
This part of ISO 7494 specifies requirements and test methods concerning
a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.

This part of ISO 7494 also specifies requirements for instructions for use and technical description.

This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this International Standard.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 7494-2 Second edition 2015-04 [Rec# 4-221] will be superseded by recognition of ISO 7494-2 Third edition 2022-07 [Rec# 4-314]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-221] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-221] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.6640 Unit, Suction Operatory Class 1 EBR
§872.6640 Unit, Operative Dental Class 1 EIA
§872.6640 Unit, Operative Dental, Accessories Class 1 NRD
Relevant FDA Guidance and/or Supportive Publications*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Lauren Giles
 Bobak Shirmohammadi
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.