Breathing system filters for anaesthetic and respiratory use Non-filtration aspects

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2009

Publisher

British Standards Institution

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

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.

This part of ISO23328 specifies 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. The test method is intended for BSF used with a clinical breathing system.

It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.

NOTE A method for assessing filtration performance of BSF is given in ISO23328-1.

Committee	CH/121/5
DevelopmentNote	Supersedes BS EN 13328-2 and 07/30167200 DC. (09/2008) Supersedes 08/30191694 DC. (04/2009)
DocumentType	Standard
Pages	16
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 13328-2:2002 BS EN ISO 23328-2:2008 08/30191694 DC : 0 07/30167200 DC : 0

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

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
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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BS EN ISO 23328-2:2009

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

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