The SMTL are able to test the performance characteristis of nebulisers in accordance with the following standards:

  • BS EN 13544-1 Respiratory therapy equipment — Part 1: Nebulizing systems and their components  — Annex CC
     
  • ISO 27427 Anaesthetic and respiratory equipment — Nebulizing systems and components  —Annex C & D

Aerosol output and aerosol output rate

In this test, the nebuliser is filled with the required volume of a drug tracer test solution (Sodium Fluoride) and connected to a breathing simulator (a sine-wave pump). The nebuliser is conducted for a known time (e.g. 1 minute) and the filter is then exchanged and analysed.

The aerosol output rate is determined using the mass of the test substance. The experiment is then continued to collect the total mass of the test substance emmited at the patient interface.

 

Particle sizing

In this test, the aerosol size distribution is determined using a low flow cascade impactor at the manufacturer’s recommended flow rate. The driving gas is supplied by a regulated air cylinder and, the nebuliser is filled with the required volume of a druge tracer test solution (Sodium Fluoride).

The mass of test substance on the individual stages of the impactors are determined and the following are reported:

• The particle size distribution as a percentage mass of test solution for the individual stages of

the impactor

• The mass median aerodynamic diameter (MMAD) as defined in BS ISO 27427:2013 Annex B

• The geometric standard deviation (GSD) as defined in BS ISO 27427:2013 Annex B

• The respirable fraction of aerosol droplets below 5 μm in diameter (Cumulative percentage

below 5 μm) as defined in BS ISO 27427:2013 Section 3.17

 

 

If you wish to commission testing of your nebuliser to BS EN 13544-1 Annex CC or ISO 27427 Annex C & D, then contact the SMTL:

Surgical Materials Testing Laboratory, Princess of Wales Hospital, Coity Road, Bridgend, UK, CF31 1RQ.

Tel: +44 (0) 1656 752820
Email: physical@smtl.co.uk

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