ISO 10079-4-2021 PDF

Full title and description

ISO 10079-4:2021 — Medical suction equipment — Part 4: General requirements. This International Standard specifies the general safety, performance and documentation requirements that are common to all parts of the ISO 10079 series for medical suction equipment.

Abstract

This document sets out general requirements for medical suction equipment that are applicable across the ISO 10079 series. It defines the high-level safety and performance expectations and lists types of suction-related devices and applications that are excluded from the series (for example certain end-pieces, syringes, dental suction, anaesthetic gas scavenging, laboratory suction, autotransfusion, mucus extractors, ventouse equipment, suction equipment where the collection container is downstream of the vacuum pump, devices marked for endoscopic use only, and plume-evacuation systems).

General information

• Status: Published.
• Publication date: August 2021 (ISO edition 1, published 2021-08; commonly listed as 30 August 2021 in distribution catalogues).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic, respiratory and reanimation equipment.
• Edition / version: Edition 1 (2021).
• Number of pages: ISO edition: 35 pages (note: national/adopted texts — e.g., EN/BS/SS/ÖNORM adoptions — may add national forewords/annexes and show different page counts such as 44–48 pages in some catalogues).

Scope

ISO 10079-4:2021 defines the general (common) requirements that apply to medical suction equipment across the ISO 10079 series. It is intended to be referenced by the part-specific standards (for example parts covering electrically powered suction equipment, manually powered suction equipment, and suction equipment powered from a vacuum/positive-pressure gas source). The document also explicitly lists device types and applications excluded from the ISO 10079 series so that manufacturers and test laboratories know where the part-specific requirements apply and where different standards or regulations are required.

Key topics and requirements

• General safety and performance principles applicable to medical suction systems (applies across all parts of ISO 10079).
• Design and construction considerations for patient-contact and fluid-handling parts (materials, fluid pathways, prevention of cross-contamination and backflow).
• Collection container and overflow/anti-spill provisions and requirements for separation between patient and pump.
• Marking, labelling and instructions for use (including content that must be supplied with the equipment).
• Basic functional tests and performance verification methods that underpin the part-specific test protocols.
• Requirements that interact with electrical/mechanical safety norms and with other parts of the ISO 10079 series (i.e., how general requirements are intended to be used alongside part-specific standards).
• Notes on exclusions (what the series does not cover) so users avoid misapplying the standard.

Typical use and users

Primary users are medical device manufacturers (design, risk management and compliance teams), conformity assessment/test laboratories, standards and regulatory affairs specialists, hospital biomedical engineering departments, procurement staff, and notified/recognized bodies that evaluate medical suction equipment. The standard is also referenced in regulatory/recognition lists for anaesthesia/respiratory equipment.

Related standards

ISO 10079-4:2021 is part of the ISO 10079 family. Closely related parts include ISO 10079-1 (Electrically powered suction equipment, revised edition 2022), ISO 10079-2 (Manually powered suction equipment, 2022), and ISO 10079-3 (Suction equipment powered from a vacuum or positive-pressure gas source, 2022). Several national and regional adoptions exist (EN ISO/BS/SS/ÖNORM versions) which may include national forewords or annexes.

Keywords

medical suction equipment; suction device; collection container; vacuum pump; venturi suction; safety requirements; performance tests; labelling; infection control; anaesthetic and respiratory equipment; ISO 10079 series.

FAQ

Q: What is this standard?

A: ISO 10079-4:2021 is the part of the ISO 10079 suite that specifies general (common) requirements for medical suction equipment — i.e., the overarching safety, performance and documentation requirements that apply across the series.

Q: What does it cover?

A: It covers general requirements used by the part-specific standards in the ISO 10079 series (design and construction principles, labelling and instructions for use, test/verification principles, fluid-path considerations and exclusions). The document also lists specific equipment and use-cases that are not within the scope of the ISO 10079 series.

Q: Who typically uses it?

A: Device manufacturers, testing and conformity assessment laboratories, hospital biomedical engineering and procurement teams, regulatory/standards specialists, and notified/recognized bodies that assess suction equipment for safety and performance. It is also referenced by regulatory recognition lists for anaesthesia/respiratory equipment.

Q: Is it current or superseded?

A: ISO 10079-4:2021 is the current ISO edition for Part 4 (first ISO edition published in August 2021). National/regional adoptions (EN/BS/SS/ÖNORM, etc.) followed in 2021–2022; these adopted texts may include additional national material and therefore show different page counts. Users should check the ISO catalogue or their national body for the confirmed current status and any corrigenda.

Q: Is it part of a series?

A: Yes — ISO 10079-4 is part of the ISO 10079 series (which includes Part 1, Part 2 and Part 3 among others). The part-specific documents (for electrically powered, manually powered and venturi/vacuum-sourced equipment) contain the detailed test and performance requirements; Part 4 contains the common/general requirements.

Q: What are the key keywords?

A: Examples of key keywords and indexing terms: medical suction equipment, suction device, collection container, vacuum pump, venturi, safety requirements, performance tests, labelling, infection control, anaesthetic and respiratory equipment (ICS 11.040.10).