Standards Development

Scope

This document specifies the common requirements for heat and moisture exchangers (HME), breathing system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses materials, design, performance, requirements for devices supplied sterile, marking, and information to be provided by the manufacturer.

NOTE 1 Wherever the term “device” is used in this document, it refers to an HME or, HMEF or BSF.

This document also applies to HMEs or HMEFs that do not have a machine port for connecting to a ventilator.

Requirements for active HMEs are located in ISO 80601-2-74.

This document is not applicable to other types of filters:

—     those designed to protect vacuum sources or gas sample lines;

—     to filter compressed gases;

—     to protect test equipment for physiological respiratory measurements;

—     on inlet of resuscitation bags;

—     port of nebulisers.

NOTE 2 A method for assessing moisture loss from an HME/HMEF is given in ISO 9360-2: 202X.

NOTE 3 A method for assessing filtration performance of BSF/HMEF is given in ISO 9360-3:202X.

Filters used for filtering anaesthetic gases from the respiratory gas are not within scope of this document.

NOTE 4 Requirements for Active HMEs are included in ISO 80601-2-74.