BS EN ISO 23328-1:2008
Current
The latest, up-to-date edition.
Breathing system filters for anaesthetic and respiratory use Salt test method to assess filtration performance
Hardcopy , PDF
English
30-05-2008
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Method
3.1 Principle
3.2 Test conditions
3.3 Apparatus
3.4 Conditioning of BSF
3.5 Sample size
3.6 Procedure
4 Calculation and expression of test results
5 Test report
Annex A (normative) - Conditioning of BSF
Annex B (informative) - Aerosol particle size distribution
Annex C (informative) - Rationale for chosen test method
Annex D (informative) - Clauses of this part of ISO 23328
addressing the essential principles
of ISO/TR
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography
Provides 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.
| Committee |
CH/121/5
|
| DevelopmentNote |
Supersedes BS EN 13328-1 & 07/30167196 DC. (05/2008)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO23328 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.
This part of ISO23328 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.
NOTE Non-filtration aspects of BSF are addressed in ISO23328-2.
| Standards | Relationship |
| EN ISO 23328-1:2008 | Identical |
| ISO 23328-1:2003 | Identical |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
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