ISO 10079-1 Third Edition 2015-11-01

Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment

10079-1 Third Edition 2015-11-01

Standard Organization: ISO

ISO 10079-1 Third Edition 2015-11-01
Medical suction equipment - Part 1: Electrically powered suction equipment

Recognition NumberAnesthesiology
Recognition Date2018-06-07
Recognition List049
Recognition Number1-131
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Anesthesiology
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Rationale:

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.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s. Issued September 1998.


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