BS 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 HMEs for use with minimal tidal volumes of 250 ml
Hardcopy , PDF
English
31-05-2009
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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. It also explains test methods for their evaluation.
| Committee |
CH/121/1
|
| DevelopmentNote |
Supersedes 98/560510 DC. (05/2005)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO9360 specifies 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 250ml, and incorporating at least one machine port, and describes test methods for their evaluation.
| Standards | Relationship |
| I.S. EN ISO 9360-1:2009 | Identical |
| NBN EN ISO 9360-1 : 2009 | Identical |
| NEN EN ISO 9360-1 : 2009 | Identical |
| UNE-EN ISO 9360-1:2009 | Identical |
| ISO 9360-1:2000 | Identical |
| UNI EN ISO 9360-1 : 2009 | Identical |
| EN ISO 9360-1:2009 | Identical |
| NF EN ISO 9360-1 : 2009 | Identical |
| NS EN ISO 9360-1 : 2009 | Identical |
| SN EN ISO 9360-1:2009 | Identical |
| DIN EN ISO 9360-1:2009-09 | 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 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
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