Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

052

Date of Entry 07/15/2019

FR Recognition Number

1-142

ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)]

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FDA recognition of ISO 10079-1 Third Edition 2015-11-01 [Rec# 1-131] will be superseded by recognition of ISO 10079-1 Third Edition 2015-11-01 Amendment 1 (2018 [Rec# 1-142].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
§878.4780	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
§870.5050	Apparatus, Suction, Patient Care	Class 2	DWM
§874.5350	Device, Antichoke, Suction	Class 3	EWT
§878.5040	System, Suction, Lipoplasty	Class 2	MUU
§870.5910	Esophageal Thermal Regulation And Gastric Suctioning Device	Class 2	PLA