ISO 10079-4:2021
Medical suction equipment - Part 4: General requirements

Standard No.

ISO 10079-4:2021

Release Date

2021

Published By

International Organization for Standardization (ISO)

Latest

ISO 10079-4:2021

Scope

This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) dental suction equipment; e) laboratory suction; b) syringes; d) anaesthetic gas scavenging systems; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) j) ventouse (obstetric) equipment; suction equipment marked for endoscopic use only; and k) plume evacuation systems.

ISO 10079-4:2021 Referenced Document

• EN 15986 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• IEC 61672-1 Electroacoustics - Sound level meters - Part 1: Specifications
• IEC 80369-5 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications; Corrigendum 2
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 20417 Medical devices — Information to be supplied by the manufacturer
• ISO 3744 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
• ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis
• ISO 80369-3 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 2: .
• ISO 80369-6 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
• ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 10079-4:2021 history

• 2021 ISO 10079-4:2021 Medical suction equipment - Part 4: General requirements