EN ISO 8185:2007
(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)
IEC 60601-1:1988, Clause 1, applies, except as follows: Amendment (add at the end of 1.1): This International Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This International Standard 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.;This International Standard 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. This International Standard 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, this International Standard 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. Where this International Standard specifies that a Clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the humidification system under consideration. This International Standard 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. This International Standard is not applicable to nebulizers used for the delivery of drugs to patients. In the planning and design of products within the scope of this International Standard, it is advisable to give due consideration to the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex GG.
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)
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-april-2008
1DGRPHãþD
SIST EN ISO 8185:2000
SIST EN ISO 8185:2000/AC:2002
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 médicaux destinés a l'appareil respiratoire - Exigences particulieres
relatives aux systemes d'humidification respiratoires (ISO 8185:2007)
Ta slovenski standard je istoveten z: EN ISO 8185:2007
ICS:
11.040.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 8185
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.040.10 Supersedes EN ISO 8185:1997
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 24 June 2007.
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: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8185:2007: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 8185:2007) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 January 2008, and conflicting national standards
shall be withdrawn at the latest by January 2008.
This document supersedes EN ISO 8185:1997.
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 EU Directive(s).
For relationship with EU Directive(s), 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 United Kingdom.
Endorsement notice
The text of ISO 8185:2007 has been approved by CEN as EN ISO 8185:2007 without any
modifications.
ANNEX ZA
(informative)
Relationship between this standard and the Essential
Requirements of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means to conforming to
Essential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 14 June
1993 on the approximation of the laws of the Member States concerning medical devices (Medical
Device Directive).
Once this International 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 International Standard given in Table ZA.1 confers, within the
limits of the scope of this International Standard, a presumption of conformity with the
corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and EU Directive
93/42/EEC
Clause(s)/sub-clause(s) of Essential requirements (ERs) of EU Qualifying remarks/Notes
this International Standard Directive 93/42/EEC
All 1, 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
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this 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 . vi
1 Scope. 1
2 Normative references. 2
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 4
5 Classification. 4
6 Identification, marking and documents. 5
7 Power input. 7
8 Basic safety categories. 7
9 Removable protective means . 7
10 Environmental conditions. 7
11 Not used. 8
12 Not used. 8
13 General. 8
14 Requirements related to classification. 8
15 Limitation of voltage and/or energy. 8
16 Enclosures and protective covers . 8
17 Separation. 8
18 Protective earthing, functional earthing and potential equalization . 8
19 Continuous leakage currents and patient auxiliary currents. 8
20 Dielectric strength. 9
21 Mechanical strength. 9
22 Moving parts. 9
23 Surface, corners and edges. 9
24 Stability in normal use. 9
25 Expelled parts. 9
26 Vibration and noise. 9
27 Pneumatic and hydraulic power. 9
28 Suspen
...
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