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UNI EN ISO 9360-1 : 2009

Current

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

Published date

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

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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