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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 049 Date of Entry 06/07/2018 
FR Recognition Number 1-132
Standard
ISO  10079-2 Third Edition 2014-05-01
Medical suction equipment - Part 2: Manually powered suction equipment
Scope/Abstract
ISO 10079-2:2014 specifies safety and performance requirements for medical, manually powered suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both. Annex C illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
ISO 10079-2:2014 has additional requirements for suction equipment intended for field use or transport use.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies.
Transition Period
FDA recognition of ISO 10079-2 Third edition 2014-05 [Rec# 1-132] will be superseded by recognition of ISO 10079-2 Fourth edition 2022-03 [Rec# 1-155]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-132] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-132] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.5910 Esophageal Thermal Regulation And Gastric Suctioning Device Class 2 PLA
§874.5350 Device, Antichoke, Suction Class 3 EWT
§878.4680 Apparatus, Suction, Single Patient Use, Portable, Nonpowered Class 1 GCY
§878.4683 Negative Pressure Wound Therapy Non-Powered Suction Apparatus Class 2 OKO
§878.4780 Pump, Portable, Aspiration (Manual Or Powered) Class 2 BTA
§878.5040 System, Suction, Lipoplasty Class 2 MUU
§878.5040 System, Suction, Lipoplasty For Removal Class 2 QPB
§880.6740 Regulator, Vacuum Class 2 KDP
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s, issued September 1998.

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 Contact
 Sidra Mirza
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6471
  sidra.mirza@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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