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 (ISO 23328-2:2002)
11-03-2009
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
ISO 23328-2:2002 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.A method for assessing filtration performance of BSF is given in ISO 23328-1.
Committee |
CEN/TC 215
|
DevelopmentNote |
Supersedes EN 13328-2. (06/2008) Supersedes PREN ISO 23328-2. (05/2009)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Supersedes |
Standards | Relationship |
NF EN ISO 23328-2 : 2009 | Identical |
BS EN ISO 23328-2:2008 | Identical |
I.S. EN ISO 23328-2:2008 | Identical |
BS EN ISO 23328-2:2009 | Identical |
DIN EN ISO 23328-2:2008-06 | Identical |
UNE-EN ISO 23328-2:2009 | Identical |
I.S. EN ISO 23328-2:2009 | Identical |
UNI EN ISO 23328-2 : 2009 | Identical |
UNE-EN ISO 23328-2:2008 | Identical |
NS EN ISO 23328-2 : 2009 | Identical |
NEN EN ISO 23328-2 : 2009 | Identical |
SN EN ISO 23328-2 : 2009 | Identical |
UNI EN ISO 23328-2 : 2008 | Identical |
ISO 23328-2:2002 | Identical |
PN EN ISO 23328-2 : 2009 | Identical |
SS-EN ISO 23328-2:2009 | Identical |
NBN EN ISO 23328-2 : 2009 | Identical |
DIN EN ISO 23328-2:2009-07 | Identical |
12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
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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