Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
Abstract
ISO 23328-1:2003 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired gases.
ISO 23328-1:2003 is applicable to BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.
Non-filtration aspects of BSF are addressed in ISO 23328-2.
DIN EN ISO 23328-1:2008-06 (E)
Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method
to assess filtra tion performance (ISO 23328-1:2003)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Terms and definitions ……………………………………………………………………………………………………..5
3 Method ……………………………………………………………………………………………………………………………6
3.1 Principle …………………………………………………………………………………………………………………………6
3.2 Test conditions ……………………………………………………………………………………………………………….6
3.3 Apparatus ……………………………………………………………………………………………………………………….6
3.4 Conditioning of BSF ………………………………………………………………………………………………………..6
3.5 Sample size …………………………………………………………………………………………………………………….7
3.6 Procedure ……………………………………………………………………………………………………………………….7
4 Calculation and expression of test results ……………………………………………………………………….8
5 Test report ………………………………………………………………………………………………………………………8
Annex A (normative) Conditioning of BSF ………………………………………………………………………………………9
Annex B (informative) Aerosol particle size distribution ………………………………………………………………..12
Annex C (informative) Rationale for chosen test method ……………………………………………………………….13
Annex D (informative) Clauses of this part of ISO 23328 addressing the essential principles of
ISO/TR 16142 ………………………………………………………………………………………………………………..15
Requirements of EU Directive 93/42/EEC Medical devices ……………………………………………………………..16
Bibliography …………………………………………………………………………………………………………………………………17