Respiratory therapy equipment - Air entrainment devices

BS EN 13544-3:2001+A1:2009 Respiratory therapy equipment. Air entrainment devices

BS EN 13544-3 specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device.

BS EN 13544-3 also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration.

BS EN 13544-3 does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

Contents of BS EN 13544-3:

Foreword

1 Scope

2 Normative references

3 Terms and definition

3.1 Air entrainment device

4 Oxygen supply

5 Connections

5.1 Oxygen supply inlet

5.2 Air inlet attachments

6 Delivered oxygen concentration

7 Marking and identification

7.1 Marking

7.2 Colour coding

8 Information supplied by the manufacturer

9 Usability

10 Clinical evaluation

Annex A (normative) Method of test for delivered oxygen concentration

Annex B (informative) Rationale

Annex C (informative) Colour coding

Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"

Bibliography