EN ISO 8185:2009
(Main)Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995.
ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.
NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1.
ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance.
Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity.
ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.
Anfeuchter für Respirationsluft für medizinische Zwecke - Besondere Anforderungen an Anfeuchtersysteme für Respirationsluft (ISO 8185:2007)
IEC 60601-1:1988, Abschnitt 1, gilt mit folgender Ausnahme:
Ergänzung (am Ende von 1.1 zu ergänzen):
Diese Internationale Norm enthält Anforderungen für die grundlegende Sicherheit und die wesentlichen
Leistungen von Anfeuchtersystemen, wie sie in 3.6 definiert sind. Diese Internationale Norm enthält auch
Anforderungen an Einzelgeräte, die für die Verwendung in Anfeuchtersystemen ausgelegt sind, wie beheizte
Atemschläuche (Atemschläuche mit Heizdrähten) und Geräte, die zur Regelung dieser beheizten
Atemschläuche vorgesehen sind (Regelvorrichtungen für beheizte Atemschläuche). ISO 5367 legt
weitere sicherheitstechnische und Leistungsanforderungen an Atemschläuche fest.
ANMERKUNG Beheizte Atemschläuche sind medizinische elektrische Geräte und unterliegen den Anforderungen
von IEC 60601-1.
* Diese Internationale Norm enthält auch Anforderungen an aktive Wärme- und Feuchtigkeitsaustauscher
(HME von engl. „Heat and Moisture Exchangers“), die aktiv Wärme und Feuchtigkeit zusetzen, um den
Feuchtigkeitsgrad des vom HME an den Patienten abgegebenen Gases zu erhöhen. Diese Internationale
Norm gilt nicht für passive HME, die während der Einatmung einen Teil der vom Patienten ausgeatmeten
Feuchtigkeit und Wärme ohne Zusatz von Wärme und Feuchtigkeit in den Atemwegstrakt zurückführen.
ISO 9360-1 und ISO 9360-2 legen Sicherheits- und Leistungsanforderungen für passive HMEs fest und
beschreiben Verfahren zur Prüfung der Leistung.
Anfeuchter für die Atemwege können durch Gas, Strom oder beides betrieben werden. Diese Internationale
Norm wurde jedoch als Besondere Norm auf der Grundlage von IEC 60601-1 erarbeitet, die allgemeine
Anforderungen nicht nur an die elektrische Sicherheit, sondern zu sämtlichen Sicherheitsaspekten festlegt,
und viele der Anforderungen gelten deshalb auch für Anfeuchter, die nicht durch Strom betrieben werden.
Humidificateurs respiratoires médicaux - Exigences spécifiques des systèmes d'humidification respiratoires (ISO 8185:2007)
L'ISO 8185:2006 est une norme particulière basée sur la CEI 60601-1:1988 et ses amendements, Amd.1 :1991 et Amd.2 :1995.
L'ISO 8185:2006 contient les exigences de sécurité de base et les exigences en matière de performances essentielles des systèmes d'humidification. Elle contient également des exigences applicables aux dispositifs particuliers destinés à être utilisés dans les systèmes d'humidification comme les tuyaux respiratoires chauffés (tuyaux respiratoires avec résistance chauffante) et les dispositifs destinés au contrôle de ces tuyaux respiratoires chauffés (commandes de tuyaux respiratoires chauffés). L'ISO 5367 spécifie d'autres exigences de sécurité et de performance pour les tuyaux respiratoires.
NOTE Les tuyaux respiratoires sont des appareils électromédicaux et sont soumis aux exigences de la CEI 60601-1.
L'ISO 8185:2006 contient également des exigences relatives aux dispositifs échangeurs de chaleur et d'humidité actifs qui ajoutent activement de la chaleur et de l'humidité afin d'augmenter le niveau d'humidité du gaz administré au patient. Elle ne s'applique pas aux échangeurs de chaleur et d'humidité passifs qui renvoient une partie de l'humidité et de la chaleur de l'air expiré par le patient aux voies respiratoires lors de l'inspiration, sans ajout de chaleur et d'humidité. L'ISO 9360-1 et l'ISO 9360-2 spécifient les exigences de sécurité et de performance pour les échangeurs de chaleur et d'humidité passifs et décrit les méthodes applicables aux essais de performance.
Les humidificateurs des voies respiratoires peuvent fonctionner avec un gaz comprimé, à l'électricité ou les deux. Toutefois, l'ISO 8185:2006 a été élaborée comme une norme particulière basée sur la CEI 60601-1, qui donne des règles générales relatives à tous les aspects de la sécurité, pas seulement de la sécurité électrique, et de nombreuses exigences sont donc applicables aux humidificateurs qui ne fonctionnent pas à l'électricité.
L'ISO 8185:2006 ne s'applique ni aux dispositifs servant à humidifier des locaux, ni aux humidificateurs utilisés pour le chauffage, la ventilation ou la climatisation, ni aux humidificateurs utilisés dans les couveuses.
L'ISO 8185:2006 ne s'applique pas aux nébuliseurs utilisés pour administrer des médicaments aux patients.
Vlažilniki dihalnega trakta za uporabo v medicini - Posebne zahteve za dihalne vlažilne sisteme (ISO 8185:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 8185:2008
Vlažilniki dihalnega trakta za uporabo v medicini - Posebne zahteve za dihalne
vlažilne sisteme (ISO 8185:2007)
Respiratory tract humidifiers for medical use - Particular requirements for respiratory
humidification systems (ISO 8185:2007)
Anfeuchter für Respirationsluft für medizinische Zwecke - Besondere Anforderungen an
Anfeuchtersysteme für Respirationsluft (ISO 8185:2007)
Humidificateurs respiratoires médicaux - Exigences spécifiques des systèmes
d'humidification respiratoires (ISO 8185:2007)
Ta slovenski standard je istoveten z: EN ISO 8185:2009
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 8185
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 8185:2007
English Version
Respiratory tract humidifiers for medical use - Particular
requirements for respiratory humidification systems (ISO
8185:2007)
Humidificateurs respiratoires médicaux - Exigences Anfeuchter für Respirationsluft für medizinische Zwecke -
spécifiques des systèmes d'humidification respiratoires Besondere Anforderungen an Anfeuchtersysteme für
(ISO 8185:2007) Respirationsluft (ISO 8185:2007)
This European Standard was approved by CEN on 21 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 8185:2009: 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 8185:2007 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 8185:2007.
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 8185:2007 has been approved by CEN as a EN ISO 8185:2009 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) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All 1 (first paragraph), 2, 3
4 [3.6 cc)] 12.1
6 13.1, 13.2, 13.3 And via IEC 60601-1, Clause 6
6.1 aa) 13.1
6.1 d) 13.1, 13.2, 13.3 b)
6.1 e) 13.1, 13.3 a)
6.1 f) 13.1, 13.3 b)
6.3 10.1, 10.3, 12.9 And via IEC 60601-1, Subclause 6.3
6.4, 6.5 13.2
6.6 9.1 And via IEC 60601-1, Subclause 6.6
6.7 12.9 And via IEC 60601-1, Subclause 6.7
6.8.2 13.1
6.8.2 a)
2, 13.3 k), 13.3 m), 13.4, 13.5, 13.6
a),13.6 b), 13.6 c), 13.6 d), 13.6 i),
13.6 j),13.6 o)
6.8.2 d) 13.6 h)
10.1 5 And via IEC 60601-1, Subclause
10.1
Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
10.2 4
10.2.101 12.7.4
15 12.6 Via IEC 60601-1, Clause 15
16 12.6 Via IEC 60601-1, Clause 16
17 12.6 Via IEC 60601-1, Clause 17
18 12.6 Via IEC 60601-1, Clause 18
19 12.6 Via IEC 60601-1, Clause 19
20 12.6 Via IEC 60601-1, Clause 20
21 4, 5, 9.2, 12.7.1 And via IEC 60601-1, Clause 21
22 12.7.1 Via 60601-1, Clause 22
23 4, 9.2, 12.7.1 Via IEC 60601-1, Clause 23
24 4, 12.7.1 And via IEC 60601-1, Clause 24
25 12.7.1 Via IEC 60601-1, Clause 25
26 12.7.2 Via IEC 60601-1, Clause 26
28 12.7.1 Via IEC 60601-1, Clause 28
29 11.3.1 Via IEC 60601-1, Clause 29
35 12.7.3 And via IEC 60601-1, Clause 35
35.101 4, 12.7.3
36 4, 9.2, 12.5 And via IEC 60601-1, Clause 36
36.202.1 9.2
37, 38, 39, 40, 41 9.3
42 12.7.5
42.101 4, 12.7.5, 12.8.1
43 7.1, 9.3 And via IEC 60601-1, Clause 43
43.101 7.1, 7.3
44 7.2, 7.5, 7.6
44.2 7.2, 7.5
44.3 7.6
44.4 7.5
44.6 7.6
44.7 8.1, 8.4, 8.5 Via IEC 60601-1, Subclause 44.7
Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
44.8 7.1, 7.2, 7.3
45 9.2 Via IEC 60601-1, Clause 45
46 10.2 Via IEC 60601-1, Clause 46
48 7.1 Via IEC 60601-1, Clause 48
49 4, 9.2 And via IEC 60601-1, Clause 49
50 10.1, 12.8.1
50.1 12.9
50.2 10.1, 10.2
50.2 aa) 2, 12.8.1
50.2 bb) 2, 12.8.1
50.2 cc) 2, 12.8.2
51 12.8.1 Via IEC 60601-1, Clause 51
51 4
51.101, 51.102, 51.103 2, 12.8.1
52 7.2, 7.6, 9.2, 9.3, 12.7.1 Via IEC 60601-1, Clause 52
56 9.1, 12.6, 12.7.5 And via IEC 60601-1, Clause 56
56.3 9.1, 12.7.5
56.7 9.3 Via IEC 60601-1, Subclause 56.7
56.101 7.2, 7.3, 9.1, 12.8.1, 12.8.2, 13.5
56.102 7.5, 9.1, 13.5
57 12.6, 12.7.4 Via IEC 60601-1, Clause 57
58 12.6 Via IEC 60601-1, Clause 58
59 9.3, 12.6 Via IEC 60601-1, Clause 59
101 3, 4
102 3, 10.2
103 2, 9.1, 12.7.3, 12.9, 13.1, 13.2, Via IEC 60601-1, Clause 6 and via
13.6 d) IEC60601-8
201 2 Via IEC 60601-8
nd
- 1 (first paragraph and 2 This relevant Essential Requirement is
st
paragraph, 1 dash) not addressed in this European
Standard
nd
- 1 (first paragraph and 2 This relevant Essential Requirement is
nd
paragraph, 2 dash) not addressed in this European
Standard
- 6a This relevant Essential Requirement is
not addressed in this European
Standard
st
48 7.5 (1 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
nd
6.1 7.5 (2 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
rd
6.8.2 7.5 (3 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard.
6.1 13.3 (a): This relevant Essential Requirement is
not fully addressed in this European
Standard
6.1 13.3 (f) This relevant Essential Requirement is
not fully addressed in this European
Standard
nd
6.8.2 13.6 (h)(2 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
6.8.2 13.6 (h)(3rd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
6.8.2 13.6 (q) This relevant Essential Requirement is
not addressed in this European
Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
2006/42/EC
- 1.1.4 Lighting This relevant EHSR is not
addressed in this European
Standard
50, 51 1.2.2 Control devices This relevant EHSR is not fully
addressed in this European
Standard
6, 56 1.5.4 Errors of fitting This relevant EHSR is not fully
addressed in this European
Standard
- 1.6.1 Machinery maintenance This relevant EHSR is not
addressed in this European
Standard
- 1.6.2 Access to operating positions This relevant EHSR is not
and servicing points addressed in this European
Standard
- 1.6.3 Isolation of energy sources This relevant EHSR is not
addressed in this European
Standard
- 3.6.2 Marking This relevant EHSR is not
addressed in this European
Standard
INTERNATIONAL ISO
STANDARD 8185
Third edition
2007-07-01
Respiratory tract humidifiers for medical
use — Particular requirements for
respiratory humidification systems
Humidificateurs respiratoires médicaux — Exigences spécifiques des
systèmes d'humidification respiratoires
Reference number
ISO 8185:2007(E)
©
ISO 2007
ISO 8185:2007(E)
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ISO 8185:2007(E)
Contents Page
Foreword. v
Introduction .
...
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