Name: UNI EN ISO 23328-1 : 2008
Brand: UNI

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

Published date

09-25-2008

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC Medical devices
Bibliography

Describes 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	CT 44
DevelopmentNote	Supersedes UNI EN 13328-1. (09/2008)
DocumentType	Test Method
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN 13328-1 : 2003

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