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UNI EN ISO 9360-1 : 2009
Current
The latest, up-to-date edition.
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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
02-07-2009
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
Describes 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, and describes test methods for their evaluation.
Committee |
CT 44
|
DocumentType |
Test Method
|
PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
Status |
Current
|
Supersedes |
Standards | Relationship |
I.S. EN ISO 9360-1:2009 | Identical |
NBN EN ISO 9360-1 : 2009 | Identical |
BS 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 |
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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