EN ISO 23328-1:2008
Current
The latest, up-to-date edition.
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
03-19-2008
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Method
3.1 Principle
3.2 Test conditions
3.3 Apparatus
3.4 Conditioning of BSF
3.5 Sample size
3.6 Procedure
4 Calculation and expression of test results
5 Test report
Annex A (normative) - Conditioning of BSF
Annex B (informative) - Aerosol particle size distribution
Annex C (informative) - Rationale for chosen test method
Annex D (informative) - Clauses of this part of ISO 23328
addressing the essential principles
of ISO/TR
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography
ISO 23328-1:2003 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired gases. ISO 23328-1:2003 is applicable to 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.Non-filtration aspects of BSF are addressed in ISO 23328-2.
Committee |
CEN/TC 215
|
DevelopmentNote |
Supersedes EN 13328-1. (05/2008)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Supersedes |
Standards | Relationship |
DIN EN ISO 23328-1:2008-06 | Identical |
SN EN ISO 23328-1:2008 | Identical |
SS-EN ISO 23328-1:2008 | Identical |
I.S. EN ISO 23328-1:2008 | Identical |
NS EN ISO 23328-1 : 1ED 2008 | Identical |
NF EN ISO 23328-1 : 2008 | Identical |
BS EN ISO 23328-1:2008 | Identical |
NBN EN ISO 23328-1 : 2008 | Identical |
NEN EN ISO 23328-1 : 2008 | Identical |
PN EN ISO 23328-1 : 2008 | Identical |
UNE-EN ISO 23328-1:2008 | Identical |
ISO 23328-1:2003 | Identical |
UNI EN ISO 23328-1 : 2008 | 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 |
ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
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