EN ISO 9360-1:2009
Current
The latest, up-to-date edition.
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)
22-04-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements and recommendations
5.1 HME patient port connector
5.2 Additional ports
5.3 Packaging of sterile HME
6 Test methods
6.1 General
6.2 Measurement of moisture loss
6.3 Measurement of pressure drop
6.4 Test for gas leakage
6.5 Test for compliance
7 Marking
Annex A (informative) - Lists of parts and specifications
in Figures 1 and 2
Annex B (informative) - Rationale
Annex ZA (Informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC
Defines certain requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port.
| Committee |
CEN/TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| PN EN ISO 9360-1 : 2009 | Identical |
| NEN EN ISO 9360-1 : 2009 | Identical |
| ISO 9360-1:2000 | Identical |
| I.S. EN ISO 9360-1:2009 | Identical |
| SS-EN ISO 9360-1 : 2009 | Identical |
| NBN EN ISO 9360-1 : 2009 | Identical |
| NF EN ISO 9360-1 : 2009 | Identical |
| BS EN ISO 9360-1:2009 | Identical |
| NS EN ISO 9360-1 : 2009 | Identical |
| DIN EN ISO 9360-1:2009-09 | Identical |
| UNE-EN ISO 9360-1:2009 | Identical |
| 00/563809 DC : DRAFT AUG 2000 | BS EN 13328-2 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| 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 13328-2:2004-03 | BREATHING SYSTEM FILTERS FOR ANESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| I.S. EN 13328-2:2002 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| DIN EN 13718-2:2015-05 | 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 13328-2:2002 | Breathing system filters for anaesthetic and respiratory use Non-filtration aspects |
| 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 |
| EN 13328-2:2002/A1:2003 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTERATION ASPECTS |
| UNE-EN 13718-2:2015 | 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 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |