UNI EN ISO 23328-2 : 2009
Current
The latest, up-to-date edition.
BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
02-07-2009
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 |
CT 44
|
| DevelopmentNote |
Supersedes UNI EN 13328-2. (09/2008)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 23328-2:2009 | Identical |
| ISO 23328-2:2002 | 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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