SIST EN ISO 8185:2008
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)
Ergänzung:
ISO 8185 ist Teil einer Internationalen Normenreihe, die auf IEC 60601-1 basiert; in IEC 60601-1 (der ?Allgemeinen Festlegung") wird diese Art Internationale Norm wird als ?Besondere Festlegung" bezeichnet. Wie in 1.3 von IEC 60601-1:1988 festgestellt, haben die Anforderungen dieser Internationalen Norm Vorrang vor denen der IEC 60601-1.
Anfeuchter können durch Gas, Strom oder beides betrieben werden. Diese Internationale Norm wurde jedoch als Besondere Festlegung 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. Wo diese Internationale Norm festlegt, dass ein Abschnitt von IEC 60601-1 gilt, bedeutet dies, dass der Abschnitt nur dann gilt, wenn die Anforderung für das jeweilige Anfeuchtersystem von Bedeutung ist.
Diese Internationale Norm enthält Sicherheits- und Leistungsanforderungen an Anfeuchter im Sinne der Begriffsbestimmung in 1.3.107, die zum Einbau in Atemsysteme geeignet sind.
Außerdem enthält diese Internationale Norm einige Anforderungen an Zuleitungsschläuche, einschließlich beheizter Zuleitungsschläuche (Zuleitungsschläuche mit Heizdrähten), und an Vorrichtungen zur Regelung dieser beheizten Zuleitungsschläuche (Regelvorrichtungen für beheizte Zuleitungsschläuche). ISO 5367 legt weitere Sicherheits- und Leistungsanforderungen für Zuleitungsschläuche fest.
* Diese Internationale Norm enthält auch einige Anforderungen an aktive Wärme- und Feuchtigkeits-austauscher (HMEs 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. ISO 9360 legt weitere Sicherheits- und Leistungsanforderungen für HMEs fest und beschreibt Verfahren zur Prüfung der Leistung. Diese Internationale Norm gilt nicht für passive HMEs, die w
Humidificateurs médicaux destinés a l'appareil respiratoire - Exigences particulieres relatives aux systemes 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
SIST EN ISO 8185:2008
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
SIST EN ISO 8185:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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EN ISO 8185:2007 (E)
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.
2
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EN ISO 8185:2007 (E)
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
3
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EN ISO 8185:2007 (E)
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
4
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EN ISO 8185:2007 (E)
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.
5
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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
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ISO 8185:2007(E)
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ii © ISO 2007 – All rights reserved
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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 Suspended masses. 9
29 X-Radiation. 10
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 10
31 Microwave radiation. 10
32 Light radiation (including lasers) . 10
33 Infra-red radiation . 10
34 Ultraviolet energy. 10
35 Acoustical energy (including ultrasonics) . 10
© ISO 2007 – All rights reserved iii
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ISO 8185:2007(E)
36 Electromagnetic compatibility. 11
37 Locations and basic requirements. 11
38 Marking, accompanying documents. 11
39 Common requirements for category AP and category APG equipment . 11
40 Requirements and tests for category AP equipment, parts and components thereof. 11
41 Requirements and tests for category APG equipment, parts and components thereof . 11
42 Excessive temperatures. 11
43 * Fire prevention. 12
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection . 12
45 Pressure vessels and parts subject to pressure . 13
46 Human error. 13
47 Electrostatic charges. 13
48 Biocompatibility . 13
49 Interruption of power supply . 13
50 Accuracy of operating data. 14
51 * Protection against hazardous output . 14
52 Abnormal operation and fault conditions. 15
53 Environmental tests. 16
54 General. 16
55 Enclosure and covers. 16
56 Components and general assembly . 16
57 Mains parts, components and layout. 17
58 Protective earthing — Terminals and connections . 17
59 Construction and layout. 18
101 * Humidification system output . 18
102 Liquid container . 18
103 Alarm systems. 18
Annex AA (informative) Rationale. 20
Annex BB (normative) * Determination of the accuracy of the displayed temperature. 27
Annex CC (informative) Specific enthalpy calculations . 29
Annex DD (normative) Temperature sensors and mating ports. 35
Annex EE (normative) * Determination of humidification system output . 36
Annex FF (normative) * Standard temperature sensor. 39
Annex GG (informative) Environmental aspects. 41
Annex HH (informative) Reference to the essential principals of safety and performance. 44
Annex II (informative) Terminology — Index of defined terms . 46
Bibliography . 48
iv © ISO 2007 – All rights reserved
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ISO 8185:2007(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 that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8185 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This third edition cancels and replaces the second edition (ISO 8185:1997), which has been technically
revised. It also incorporates the Technical Corrigendum, ISO 8185:1997/Cor. 1:2001.
© ISO 2007 – All rights reserved v
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ISO 8185:2007(E)
Introduction
This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by, or under the supervision of, qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable
equipment, such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc.
The Particular Standards apply to specific equipment types, such as medical electron accelerators, high
frequency surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard are found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this International Standard, the following drafting conventions have been applied.
This International Standard uses the same main Clause titles and numbering as the General Standard, to
facilitate cross-referencing of the requirements. The changes to the text of the General Standard are specified
by the use of the following words.
⎯ “Replacement” means that the indicated Clause or Subclause of the General Standard is replaced
completely by the text of this International Standard.
⎯ “Addition” means that the relevant text of this International Standard is supplementary to the requirements
of the General Standard.
⎯ “Amendment” means that existing text of the General Standard is modified as indicated by the text of this
International Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: subclauses, tables and figures are numbered
starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB,
etc.
In this International Standard, the following print types are used:
⎯ requirements, compliance with which can be verified, and definitions: roman type;
⎯ notes and examples: smaller roman type;
⎯ description of type of document change and test methods: italic type;
⎯ terms defined in the General Standard IEC 60601-1:1988, Clause 2 or in this International Standard: bold
type.
Throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an
asterisk (*).
vi © ISO 2007 – All rights reserved
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ISO 8185:2007(E)
Humidifiers are used to raise the water content of gases delivered to patients. Gases available for medical
use do not contain sufficient moisture and can damage or irritate the respiratory tract or desiccate secretions
of patients whose upper airways have been bypassed. Reduction of the relative humidity at the patient
connection port can cause desiccation of tracheo-bronchial secretions in the tracheal or tracheostomy tube,
[19]
and consequently may cause narrowing or even obstruction of the airway . Heat can be employed to
increase the water output of the humidifier.
In addition, many humidifiers utilise heated breathing tubes in order to increase operating efficiency and
reduce water and heat loss. Ventilator and anaesthesia breathing tubes in common use might not withstand
the heat generated by humidifiers and heated breathing tube mechanisms.
Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically-heated breathing
tubes. However, since different manufacturers have used the same electrical connector for different power
outputs, electrically-heated breathing tubes can be physically, but not electrically, interchangeable. Use of
improper electrically-heated breathing tubes has caused overheating, circuit melting, patient and operator
burns, and fires. It was not found practical to specify the interface requirements for electrical connectors to
ensure compatibility between humidifiers and breathing tubes produced by different manufacturers.
Since the safe use of a humidifier depends on the interaction of the humidifier with its many accessories,
this International Standard sets total-system performance requirements, applicable to accessories such as
breathing tubes (both heated and non-heated), temperature sensors, and devices intended to control the
environment within these breathing tubes.
© ISO 2007 – All rights reserved vii
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INTERNATIONAL STANDARD ISO 8185:2007(E)
Respiratory tract humidifiers for medical use — Particular
requirements for respiratory humidification systems
1 Scope
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
...
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