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: 21-Apr-2009
• Withdrawal Date: 20-Mar-2010
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 22-Apr-2009
• Completion Date: 22-Apr-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: 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)

Relations

• Replaces: 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: 06-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 9360-1:2000
$QHVWH]LMVNDLQGLKDOQDRSUHPD,]PHQMHYDOQLNLWRSORWHLQYODJH+0(V]D
QDYODåHYDQMHGLKDOQLKSOLQRYYþORYHNXGHO+0(V]DXSRUDER]QDMPDQMãR
GLKDOQRSURVWRUQLQRPO,62
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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
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] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9360-1:2000.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 9360-1:2000 has been approved by CEN as a EN ISO 9360-1:2009 without any modification.
Annex ZA
(Informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 – Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes

4 13.2
5 7.5 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 7.5 (2nd paragraph) This relevant Essential
Requirement is not
addressed in this European
Standard
- 7.5 (3rd paragraph) This relevant Essential
Requirement is not
addressed in this European
Standard
5.1 9.1, 13.6 c)
5.2 9.1, 13.6 c)
5.3 8.3
5, 6, 7 1 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5, 6, 7 1 (2nd paragraph, 1st dash) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5, 6, 7 1 (2nd paragraph, 2nd This relevant Essential
Requirement is not fully
dash)
addressed in this European
Standard
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
- 6a) This relevant Essential
Requirement is not
addressed in this European
Standard
7.1 a) 9.1, 13.2, 13.3 k), 13.6 c)

7.1 b) 9.1, 13.2, 13.3 j)
7.2 13.1
7.2 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 13.3 (f) This relevant Essential
Requirement is not
addressed in this European
Standard
- 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not
addressed in this European
Standard
7.2 a) 13.3 a)
7.2 b) 13.3 b)
7.2 c) 8.7, 13.3 c)
7.2 d) 13.3 i)
7.2 e) 13.3 l)
7.2 f) 13.3 e)
7.3 13.3 f)
7.4 13.1
7.4 13.6 (q) This relevant Essential
Requirement is not
addressed in this European
Standard
7.4 a) 13.1, 13.6 a), 13.6 b)
7.4 b) 9.1, 13.3 j)
7.4 d) 13.6 b)
7.4 f) 13.6 b)
7.4 g) 13.6 b)
7.4 h) 13.3 j), 13.3 k)
7.4 i) 13.3 m), 13.6 h)
7.4 j) 13.3 j), 13.3 k)
7.4 k) 13.6 n)
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 9360-1
First edition
2000-03-15
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
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
Reference number
ISO 9360-1:2000(E)
©
ISO 2000
ISO 9360-1:2000(E)
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ISO 9360-1:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Symbols and abbreviated terms .2
5 General requirements and recommendations.2
5.1 HME patient port connector.2
5.2 Additional ports .2
5.3 Packaging of sterile HME.3
6 Test methods.3
6.1 General.3
6.2 Measurement of moisture loss.3
6.3 Measurement of pressure drop.13
6.4 Test for gas leakage .13
6.5 Test for compliance.13
7 Marking .15
Annex A (informative) Lists of parts and specifications in Figures 1 and 2 .17
Annex B (informative) Rationale.18
ISO 9360-1:2000(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on th
...