SIST EN ISO 9360-1:2009

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)

This part of ISO 9360 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 250 ml, and incorporating at least one machine port, and
describes test methods for their evaluation.

Anästhesie- und Beatmungsgeräte - Wärme- und Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen beim Menschen - Teil 1: Wärme- und Feuchtigkeitsaustauscher zur Verwendung bei Mindesthubvolumina von 250 ml (ISO 9360-1:2000)

Matériel d'anesthésie et de réanimation respiratoire - Échangeurs de chaleur et d'humidité (ECH) utilisés pour humidifier les gaz respirés par les êtres humains - Partie 1: ECH pour utilisation avec des volumes courants d'au moins 250 ml (ISO 9360-1:2000)

La présente partie de l'ISO 9360 spécifie certaines exigences relatives aux échangeurs de chaleur et d'humidité (ECH), y compris ceux équipés de filtres pour systèmes respiratoires, essentiellement destinés à humidifier les gaz respirés par les patients ayant un volume courant supérieur ou égal à 250 ml, et comportant au moins un orifice côté appareil, et décrit des méthodes d'essai permettant de les évaluer.

Anestezijska in dihalna oprema - Izmenjevalniki toplote in vlage (HMEs) za navlaževanje dihalnih plinov v človeku - 1. del: HMEs za uporabo z najmanjšo dihalno prostornino 250 ml (ISO 9360-1:2000)

General Information

• Status: Published
• Publication Date: 31-May-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-May-2009
• Due Date: 24-Jul-2009
• Completion Date: 01-Jun-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 9360-1:2009 - 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)

Relations

• Replaces: SIST EN ISO 9360-1:2000 - 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)
• Effective Date: 01-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9360-1:2009
01-julij-2009
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SIST EN ISO 9360-1:2000
$QHVWH]LMVNDLQGLKDOQDRSUHPD,]PHQMHYDOQLNLWRSORWHLQYODJH+0(V]D
QDYODåHYDQMHGLKDOQLKSOLQRYYþORYHNXGHO+0(V]DXSRUDER]QDMPDQMãR
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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 (ISO 9360-1:2000)
Anästhesie- und Beatmungsgeräte - Wärme- und Feuchtigkeitsaustauscher zur
Anfeuchtung von Atemgasen beim Menschen - Teil 1: Wärme- und
Feuchtigkeitsaustauscher zur Verwendung bei Mindesthubvolumina von 250 ml (ISO
9360-1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Échangeurs de chaleur et
d'humidité (ECH) utilisés pour humidifier les gaz respirés par les êtres humains - Partie
1: ECH pour utilisation avec des volumes courants d'au moins 250 ml (ISO 9360-1:2000)
Ta slovenski standard je istoveten z: EN ISO 9360-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9360-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9360-1:2009

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SIST EN ISO 9360-1:2009
EUROPEAN STANDARD
EN ISO 9360-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 9360-1:2000
English Version
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)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Wärme- und
Échangeurs de chaleur et d'humidité (ECH) utilisés pour Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen
humidifier les gaz respirés par les êtres humains - Partie 1: beim Menschen - Teil 1: Wärme- und
ECH pour utilisation avec des volumes courants d'au moins Feuchtigkeitsaustauscher zur Verwendung bei
250 ml (ISO 9360-1:2000) Mindesthubvolumina von 250 ml (ISO 9360-1:2000)
This European Standard was approved by CEN on 28 March 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9360-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 9360-1:2009
EN ISO 9360-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 9360-1:2009
EN ISO 9360-1:2009 (E)
Foreword
The text of ISO 9360-1:2000 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 9360-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC]
...