ISO 10079-3-2022 PDF

Full title and description

ISO 10079-3:2022 — Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source. This International Standard specifies basic safety and performance requirements for medical suction equipment that is powered from a vacuum or positive-pressure gas source (venturi suction), including equipment connected to medical gas pipeline systems or cylinders and associated venturi attachments; equipment may be standalone or part of an integrated system.

Abstract

This document establishes minimum safety and performance criteria for venturi-type suction devices used in healthcare settings. It addresses essential functional requirements, connection to medical gas supplies, and limits/exemptions referenced from the general requirements in the ISO 10079 series. The Part 3 edition of 2022 updates and replaces earlier editions.

General information

• Status: Published / Current.
• Publication date: March 2022 (ISO publication), with national/adoption publications during 2022 (EN/UNE adoptions in late 2022).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic and respiratory equipment; medical suction equipment.
• Edition / version: Edition 4 — ISO 10079-3:2022 (revises and replaces the 2014 edition).
• Number of pages: ISO metadata lists 3 pages for the ISO record, while a number of national/adopted publications and resellers list longer published consolidated texts (commonly reported as 8–11 pages for adopted EN/UNE documents). Users should check the official ISO publication or their national adoption for the exact page count of the version they obtain.

Scope

ISO 10079-3:2022 applies to suction equipment that is powered by a vacuum or positive-pressure gas source producing venturi suction. The standard covers safety and performance requirements for equipment connected to medical gas pipeline systems or to gas cylinders, and for venturi attachments; it applies to both standalone devices and units integrated into larger systems. Exemptions and general rules given in ISO 10079-4 (general requirements for the ISO 10079 series) are referenced and apply where noted.

Key topics and requirements

• Basic safety requirements for venturi-powered suction equipment (design and construction to minimise risk to patients and operators).
• Performance requirements, including suction generation characteristics and functional stability when connected to medical gas supplies.
• Requirements and guidance for connections to medical gas pipeline systems and cylinders, and for venturi attachments.
• Reference to ISO 10079-4 for general requirements and any applicable exemptions; integration and interface considerations for systems.
• Marking, documentation and user information required to ensure safe selection, installation, and maintenance.

Typical use and users

Intended users include medical device manufacturers (design and conformity assessment), hospital biomedical/clinical engineering staff, procurement teams, test laboratories, and regulatory bodies responsible for the safety and performance of clinical suction systems. Typical applications are in hospitals and clinical environments where suction is required for airway clearance, surgical suction, and drainage when venturi-powered solutions are used or specified.

Related standards

ISO 10079-3:2022 is part of the ISO 10079 series on medical suction equipment. Closely related documents include ISO 10079-1 and ISO 10079-2 (other parts of the series dealing with electrically powered suction equipment and other classifications), and ISO 10079-4 (general requirements for the series). Regional/adopted equivalents appear as EN ISO 10079-3:2022 and national adoptions (UNE-EN ISO 10079-3, ÖNORM EN ISO 10079-3, etc.).

Keywords

medical suction equipment; venturi suction; hospital central vacuum systems; medical gas pipeline; suction attachments; performance requirements; safety; ISO 10079 series.

FAQ

Q: What is this standard?

A: ISO 10079-3:2022 is an International Standard that sets safety and performance requirements for medical suction equipment powered by a vacuum or positive-pressure gas source (venturi suction).

Q: What does it cover?

A: It covers basic safety and performance criteria, connections to medical gas pipelines or cylinders, venturi attachments, and documentation/marking requirements; it also references ISO 10079-4 for general requirements and exemptions.

Q: Who typically uses it?

A: Manufacturers of suction equipment, hospital biomedical engineers, testing laboratories, procurement and regulatory personnel, and anyone responsible for selection, installation, maintenance, or conformity assessment of venturi-powered suction systems.

Q: Is it current or superseded?

A: ISO 10079-3:2022 is the current published edition (published in 2022) and supersedes ISO 10079-3:2014 and earlier editions. National/adopted versions (EN/UNE/others) were published/adopted in 2022. Users should confirm the edition and any national deviations when purchasing the document.

Q: Is it part of a series?

A: Yes — it is part of the ISO 10079 series on medical suction equipment (other parts cover electrically powered devices, other device classes, and general requirements).

Q: What are the key keywords?

A: Venturi suction; medical suction equipment; medical gas pipeline; suction attachments; safety; performance; ISO 10079.