EN ISO 8185:2007

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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ii © ISO 2007 – All rights reserved

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 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

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 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

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.

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 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.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
ISO 8185:2007(E)
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources using sound pressure —
Engineering method in an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5367:2000, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7396-1:2002, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and
vacuum
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 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum
tidal volumes of 250 ml
ISO 10524-1:2006, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety, and its
Amendment 1:1991 and Amendment 2:1995
IEC 60601-1-2:2001, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2004, Medical electrical equipment — Part 1-6: General requirements for safety — Collateral
standard: Usability
IEC 60601-1-8:2003, Medical electrical equipment — Part 1-8: General requirements for safety — Collateral
standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and
medical electrical systems
IEC 60601-2-19:1990, Medical electrical equipment — Part 2: Particular requirements for safety of baby
incubators
3 Terms and definitions
For the purposes of this document, the terms and definitions given in Clause 2 of IEC 60601-1:1988,
IEC 60601-1-8:2003, ISO 4135:2001, and the following apply.
NOTE For convenience, the sources of all defined terms used in this International Standard are given in Annex II.
3.1
accessible surface temperature
temperature of any surface which can be touched by a hand or finger during normal use, which includes
filling and refilling of the humidifier
2 © ISO 2007 – All rights reserved

ISO 8185:2007(E)
3.2
active HME
device where water, water vapour or heat is actively added to the heat and moisture exchanger (HME) to
increase the humidity level of the gas delivered from the HME to the patient
3.3
delivered gas temperature
temperature of the gas, or aerosol, or both, at the patient connection port
3.4
heated breathing tube controller
device which controls the temperature or the heating of a breathing tube
NOTE The controller can be either stand-alone or part of the humidifier.
3.5
humidification chamber
part of the humidifier in which vaporization or nebulization takes place
3.6
humidification system
complete system that comprises a humidifier and accessories
NOTE Accessories can include a breathing tube (heated or unheated), breathing tube heater, heated breathing
tube controller, and temperature sensor.
3.7
humidification system output
total mass of water (in the form of liquid and vapour) per unit volume of gas normalized to body temperature,
atmospheric pressure and saturated (BTPS), i.e. at 37 °C, 101,3 kPa (760 mmHg) and saturated with water
vapour at the patient connection port
3.8
humidifier
device that adds water in the form of droplets or vapour, or both, to the inspired gas
NOTE This term includes vaporizing, bubble-through and ultrasonic humidifiers and active heat and moisture
exchangers (HMEs).
3.9
liquid container
part of the humidifier which holds the liquid
NOTE 1 The liquid container can be accessible to the breathing gas.
NOTE 2 The liquid container can also be part of the humidification chamber.
NOTE 3 The liquid container can be detachable for filling.
3.10
liquid reservoir
part of the humidifier which replenishes the liquid container
3.11
maximum operating pressure
maximum pressure in the humidification chamber
3.12
measured gas temperature
temperature of the gas, or aerosol, or both, that the humidification system is measuring and, if applicable,
displaying
ISO 8185:2007(E)
3.13
relative humidity
water vapour pressure, expressed as a percentage of the saturation vapour pressure, at a particular
temperature
3.14
set temperature
temperature at which the humidification system attempts to maintain measured gas temperature
NOTE The set temperature can be operator-adjustable.
4 General requirements and general requirements for tests
IEC 60601-1:1988, Clauses 3 and 4, apply, except as follows:
3.6
Addition:
aa) Operation of the humidifier without any liquid.
bb) If the humidifier includes a temperature sensor, any single fault condition with the temperature sensor.
For example:
⎯ temperature sensor single open-circuit;
⎯ temperature sensor single short-circuit;
⎯ temperature sensor disconnected from the humidifier control system; or
⎯ temperature sensor disconnected from breathing tube or humidifier.
cc) A safety hazard (e.g. thermal injury to the patient) resulting from software error.
4.6 Other conditions
Addition:
aa) The test gas shall be medical-grade air, medical-grade oxygen, or a mixture of the two.
NOTE Reference test gas to BTPS (37 °C, RH = 100 %, 101 kPa)
bb) Unless otherwise specified, the liquid container and liquid reservoir, if provided, shall be filled to
maximum capacity, as indicated in the instructions for use, at the beginning of a test with distilled water at
the ambient test temperature.
cc) For the purpose of checking compliance with requirements of this International Standard, the delivered
gas temperature shall be sensed in the breathing tube no more than 50 mm from the patient
connection port (see Annex BB).
5 Classification
IEC 60601-1:1988, Clause 5, applies.
4 © ISO 2007 – All rights reserved

ISO 8185:2007(E)
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6, applies, except as follows:
6.1 Markings on the outside of equipment or equipment parts
Amendment:
g) * Connection to the supply
NOTE A heated breathing tube connector to the humidifier or heated breathing tube controller is a connection to
the supply that can need this marking.
Amendment (add at end of item):
p) Output
NOTE The applied part electrical connector of a humidifier for heated breathing tubes is an output that needs this
marking.
Addition:
aa) The marking on the outside shall also include the following:
1) the maximum and minimum liquid levels, if these are necessary for the correct operation of the
humidifier;
2) the direction of flow, for a humidifier or humidification system with flow-direction-sensitive
components;
3) if a pressure-relief mechanism is provided, the pressure at which it opens. This marking shall be on
or near the pressure-relief device;
4) * if the humidifier is driven by compressed gas, the ranges of the supply flowrates and pressures
that are required;
5) the humidification system and its parts shall be marked with regard to proper disposal, as
appropriate.
6.8.2 Instruction for use
a) General Information
Amendment (add after the last bullet):
⎯ The instructions for use shall also include the following information:
1) * For a humidifier, identification of at least one set of accessories and, if applicable, a ventilator
necessary for its intended use, and a warning to the effect that it is potentially unsafe to configure a
humidifier with breathing tubes or accessories and a ventilator that are not specified for use with
the humidifier.
2) For breathing tubes or other accessories intended to be used within humidification systems,
identification of at least one humidifier that, when used with the breathing tube or accessories, will
meet the requirements of this International Standard.
3) * A warning to the effect that it is potentially unsafe to configure breathing tubes or accessories
with any humidifier and ventilator that are not specified for use with these breathing tubes or
accessories.
ISO 8185:2007(E)
4) * If the humidifier entrains air for the purpose of diluting oxygen, the following shall be provided:
i) a statement to the effect that the oxygen concentration can be affected by a partial obstruction
downstream of the humidifier, e.g. when using accessory equipment;
ii) a recommendation that the oxygen concentration be measured at the point of delivery to the
patient.
5) The intended use of the humidification system, and whether or not the humidification system is
intended for use with a patient whose upper airways have been bypassed.
6) * If the humidifier is intended for use with patients whose upper airways are bypassed, the
operating range of gas flowrates and settings which provide a humidification system output of at
least 33 mg/l.
7) The maximum volume of water, expressed in millilitres, available for vaporization contained in the
liquid container and, if provided, in the liquid reservoir.
8) If the humidifier is powered by pressurized gas, the rated ranges of flowrates and supply pressures
and method(s) of connection.
9) The maximum operating pressure of the humidifier.
10) * The inspiratory and expiratory pressure drop, as a function of flowrate, across the humidification
system or individual components, as appropriate. The pressure drop should be determined in
accordance with ISO 5367 or an equivalent method. The pressure drop for active HMEs should be
determined in accordance with ISO 9360-1 and ISO 9360-2.
11) The gas leakage of the humidification system or individual components, as appropriate, at the
maximum operating pressure. The gas leakage should be determined in accordance with
ISO 5367 or an equivalent method. The gas leakage for active HMEs should be determined in
accordance with ISO 9360-1 and ISO 9360-2.
12) * The internal compliance of the humidification system or individual components, as appropriate. If
this internal compliance can be affected by the depletion of the liquid, the minimum and maximum
compliance values shall be disclosed. The internal compliance should be determined in accordance
with ISO 5367 or an equivalent method. The internal compliance for active HMEs should be
determined in accordance with ISO 9360-1 and ISO 9360-2.
13) The humidification system output and relative humidity over the recommended operating range
of gas flowrates and settings.
14) The time required (warm-up time) for the measured gas temperature to reach the set temperature
from a starting temperature of (23 ± 2) °C when operated in accordance with the accompanying
documents.
15) The maximum delivered gas temperature, if the humidification system is not provided with a
means of continuously indicating the measured gas temperature.
16) Appropriate warning about operation of the breathing tubes if they can be affected by normal clinical
procedures (e.g. tubes covered with a blanket or heated in an incubator or overhead heater for a
neonate).
17) The operating ambient temperature range and the operating gas inlet temperature range.
18) A warning if humidity performance of the device can be compromised when used outside the
specified ambient temperature range or humidity range.
6 © ISO 2007 – All rights reserved

ISO 8185:2007(E)
19) Known adverse effects on the performance of the humidification system when exposed to, for
example, electrocautery, electrosurgery, defibrillation, X-ray (gamma radiation), infrared radiation,
conducted transient magnetic fields including magnetic resonance imaging (MRI), and
radiofrequency interference.
20) Information concerning the disposal of the humidification system or components thereof.
21) * The location in the humidification system to which the displayed gas temperature is referenced.
Replacement:
d) For components specified for reuse, which come into contact with the patient or breathing gases during
normal use, the instructions for use shall contain:
⎯ any details about cleaning and disinfection or cleaning and sterilisation methods that can be used
(see 44.7);
⎯ the list of the applicable parameters such as temperature, pressure, humidity, time limits and number
of cycles that such humidification system, parts or accessories can tolerate.
For non-patient contact parts, a list of cleaning solutions suitable for cleaning those parts.
7 Power input
IEC 60601-1:1988, Clause 7 applies.
8 Basic safety categories
IEC 60601-1:1988, Clause 8 applies.
9 Removable protective means
IEC 60601-1:1988, Clause 9 applies.
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies, except as follows:
10.2.1 Environment
Replacement:
a) An operating ambient temperature range as specified in the accompanying documents.
Addition:
10.2.101 Pneumatic power supply
If the humidifier is intended to be connected to a medical gas supply system (either a medical gas pipeline
system complying with ISO 7396-1 or a pressure regulat
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