DIN EN ISO 23328-1:2008-06
Current
The latest, up-to-date edition.
BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE
Hardcopy , PDF
English
01-01-2008
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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 16142
Requirements of EU Directive 93/42/EEC Medical devices
Annex ZA (informative) Relationship between this European
Standard and the Essential
Bibliography
National Annex NA (informative) 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.
| DevelopmentNote |
Supersedes DIN EN 13328-1 E. (08/2008)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 23328-1:2008 | Identical |
| ISO 23328-1:2003 | Identical |
| CFR 42(PTS1-399) : OCT 2017 | PUBLIC HEALTH - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| 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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