We will be carrying out essential maintenance activity on this website on Saturday 1st August between 0600 and 1300 UK time. You might experience some brief interruption or loss of some functionality. We apologise for any inconvenience this may cause.

PNW 62D-2275 ED1: Medical electrical equipment -- Part 97: Particular requirements for basic safety and essential performance of respiratory home high-flow therapy equipment

Scope

A home high flow therapy (HFT) device blows air at a controlled flowrate, humidifies and conducts the air through a heated tube. The heated tube connects to a respiratory high -flow nasal cannula.

Room air is drawn into the device by a blower such as a turbine.

Supplemental oxygen is commonly sourced from equipment for long term oxygen therapy such as a home cylinder or stationary oxygen concentrator.

Home HFT is predominantly used in home healthcare facilities. It is suitable for use in professional healthcare environment to assist patient setup and trial.

Purpose

Home HFT is used by spontaneously breathing patients to relieve respiratory symptoms that interfere with daily living and to reduce the incidence of acute exacerbations requiring hospital care.

The blower, humidifier and heated tube have integrated control. A single fault in one of these can be responded by deactivating the other two to reach a safe state of inactivity.

One category of home HFT is described for devices that incorporate alarms to alert a patient or carer to incorrect device operation. A second category is described for devices that serve patient groups at lower risk.

Comment on proposal

Required form fields are indicated by an asterisk (*) character.


Please email further comments to: admin.start@bsigroup.com

Follow standard

You are now following this standard. Weekly digest emails will be sent to update you on the following activities:

You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.

Unfollow standard

You have successfully unsubscribed from weekly updates for this standard.

Error