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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 1-131
Standard
ISO 10079-1 Third Edition 2015-11-01
Medical suction equipment - Part 1: Electrically powered suction equipment
Scope/Abstract
ISO 10079-1:2015 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.

ISO 10079-1:2015 does not apply to the following:

a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;

b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;

c) syringes;

d) dental suction equipment;

e) anaesthetic gas scavenging systems;

f) laboratory suction;

g) autotransfusion systems;

h) mucus extractors including neonatal mucus extractors;

i) suction equipment where the collection container is downstream of the vacuum pump;

j) ventouse (obstetric) equipment;

k) suction equipment marked for endoscopic use only;

l) plume evacuation systems.

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FDA recognition of ISO 10079-1 Third Edition 2015-11-01 [Rec# 1-131] will be superseded by recognition of ISO 10079-1 Third Edition 2015-11-01 Amendment 1 (2018 [Rec# 1-142]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-131] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 1-131] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.5040 System, Suction, Lipoplasty Class 2 MUU
§878.4780 Apparatus, Suction, Ward Use, Portable, Ac-Powered Class 2 JCX
§878.4780 Pump, Portable, Aspiration (Manual Or Powered) Class 2 BTA
§878.4780 Wound Drain Catheter System Class 2 OTK
§874.5350 Device, Antichoke, Suction Class 3 EWT
§870.5910 Esophageal Thermal Regulation And Gastric Suctioning Device Class 2 PLA
§870.5050 Apparatus, Suction, Patient Care Class 2 DWM
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.
FDA Technical Contacts
 Sidra Mirza
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-6471
  sidra.mirza@fda.hhs.gov
 Brandon Blakley
  FDA/OMPT/CDRH/ODE/DAGRID/RPDB
  301-348-1958
  brandon.blakely@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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