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

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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	DIN EN 13328-1:2002-04

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
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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DIN EN ISO 23328-1:2008-06

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

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