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DIN
DIN EN ISO 23328-2 E : 2009

DIN EN ISO 23328-2 E : 2009

Current

Current

The latest, up-to-date edition.

BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 BSF port connectors
  4.1 BSF breathing system and patient connection
      ports
  4.2 Accessory ports
5 Test methods
  5.1 Ambient conditions of test
  5.2 Measurement of pressure drop
  5.3 Test for gas leakage
6 Packaging of sterile BSF
7 Marking
  7.1 Use of symbols
  7.2 Marking of BSF
  7.3 Marking of package
  7.4 BSF intended for single use
8 Information to be provided by the manufacturer
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
National Annex NA (informative) - Bibliography

Describes requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied.

DevelopmentNote
Supersedes DIN EN 13328-2 E. (08/2008)
DocumentType
Standard
Pages
15
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
EN ISO 23328-2:2009 Identical
ISO 23328-2:2002 Identical

DIN EN ISO 80601-2-72 E : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
DIN EN ISO 5367 E : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
DIN EN ISO 9360-1 E : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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