British Standards Institution

Source:: CEN
Committee:: CH/121/5 - Airways and related equipment
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment

Scope

This document specifies requirements for the RESPIRATORY TUBING and connectors used to convey respirable gases to a patient in the healthcare environment and provide a safe connection between the gas supply device and the PATIENT INTERFACE. RESPIRATORY TUBING and connectors are mainly used for delivery of oxygen, but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy EXTENSION TUBING.

Purpose

A more up to date version of the European standard EN 13544-2 has been developed by ISO TC121/SC2 as an ISO standard (ISO/NP 17256). This update includes the introduction of the new respiratory small-bore connector at the patient interface connection to enhance patient safety by making it non-connectable to other connectors, especially the Luer. This should be adopted in CEN when published as it is considered to enhance patient safety and to be state of the art.

Note: in case the WI is based on documents from other organizations than ISO/IEC, please specify it here

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

19/04/2022

Proposal end date:

09/05/2022

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

Revision of EN 13544-2 - Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors

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