EN 13328-2:2002/A1:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTERATION ASPECTS
01-03-2008
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 BSF port connectors
4.1 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 method for gas leakage
6 Requirements for BSFs supplied sterile
6.1 Sterility assurance
6.2 Packaging of BSFs supplied sterile
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
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Gives requirements for non-filtration aspects of breathing system filters (BSFs) intended for the filtration of respired gases in humans when used with a breathing system. It addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied.
| Committee |
TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 13328-2 : 2002 AMD 1 2004 | Identical |
| DIN EN 13328-2:2004-03 | Identical |
| PN EN 13328-2 : 2006 | Identical |
| NBN EN 13328-2 : 2003 AMD 1 2004 | Identical |
| SN EN 13328-2 : 2003 AMD 1 2004 | Identical |
| BS EN 13328-2:2002 | Identical |
| I.S. EN 13328-2:2002 | Identical |
| UNI EN 13328-2 : 2006 | Identical |
| NF EN 13328-2 : 2003 AMD 1 2004 | Identical |
| NS EN 13328-2 : 2002 AMD 1 2003 | Identical |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 1281-2 : 1995 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| EN ISO 9360-1:2009 | 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 9360-1:2000) |
| 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 |
| EN 1281-1:1997/A1:1998 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 13328-1 : 2001 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE |
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