BS EN ISO 23328-2:2009
Current
The latest, up-to-date edition.
Breathing system filters for anaesthetic and respiratory use Non-filtration aspects
Hardcopy , PDF
English
30-04-2009
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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.
| 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 |
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.
| 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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