I.S. 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
Hardcopy , PDF
English
01-01-2009
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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.
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 9360-1 : 2009 | Identical |
| BS EN ISO 9360-1:2009 | Identical |
| NEN 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 |
| UNE-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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