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I.S. EN ISO 23328-1:2008

Current

Current

The latest, up-to-date edition.

BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2008

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

DevelopmentNote
Supersedes I.S. EN 13328-1. (06/2008)
DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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
EN 143:2000/A1:2006 RESPIRATORY PROTECTIVE DEVICES - PARTICLE FILTERS - REQUIREMENTS, TESTING, MARKING
ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems

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