SIST EN ISO 8185:2000

Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)

Clause 1 of IEC 60601-1:1988 applies with the following amendment:           ISO 8185 is one of a series of International Standards based on lEC 60601-1; in IEC 60601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standardt. As stated in 1.3 of IEC 60601-1:1988, the requirements of this International Standard take precedence over those of IEC 60601-1.           Humidifiers may 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 humidifier system under consideration.           This International Standard includes requirements for the safety and performance of humidifiers, as defined in 1.3.107, suitable for inclusion in breathing systems.           This International Standard also includes some requirements for delivery tubes, including heated delivery tubes (heated-wire delivery tubes), and devices intended to control these heated delivery tubes, heated delivery tube controllers.           This International Standard is not applicable to heat and moisture exchangers (HMEs).           This International Standard is not applicable to devices commonly referred to as "room humidifiers" and humidifiers used in heating, ventilation and air conditioning systems, and humidifiers incorporated into infant incubators.           This International Standard is not applicable to nebulizers used for the delivery of drugs to patients.

Anfeuchter für medizinische Zwecke - Allgemeine Anforderungen an Anfeuchtungssysteme (ISO 8185:1997)

Abschnitt 1 von IEC 601-1:1988 gilt in Verbindung mit folgender Ergänzung: ISO 8185 ist Teil einer Internationalen Normenreihe, die auf der IEC 601-1 ("Allgemeine Festlegung") basiert. Diese Art Internationale Norm wird als "Besondere Festlegung" bezeichnet. Wie in 1.3 von IEC 601-1:1988 festgestellt, haben die Anforderungen dieser Internationalen Norm Vorrang vor denen der IEC 601-1. Anfeuchter können durch Gas, Strom oder beides betrieben werden.

Humidificateurs médicaux - Exigences générales relatives aux systemes d'humidification (ISO 8185:1997)

L'IEC 62828-4:2020 établit les procédures spécifiques d'essai des transmetteurs de niveau utilisés dans les systèmes de mesure et de commande des processus industriels et des systèmes de commande des machines. Pour les procédures d'essais générales, référence doit être faite à l'IEC 62828-1:2017, applicable à tous les types de transmetteurs.
Tout au long du présent document, le terme "transmetteurs industriels" couvre tous les types de transmetteurs utilisés dans les systèmes de mesure et de commande des processus industriels et des machines.
Les exigences du présent document s'appliquent à tous les principes de mesure du niveau.
Par souci de clarté, une description détaillée des transmetteurs est donnée pour deux principes principaux.

Vlažilniki za uporabo v medicini - Splošne zahteve za vlažilne sisteme (ISO 8185:1997)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 10-Feb-2008
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 29-Jan-2008
• Due Date: 21-Feb-2008
• Completion Date: 11-Feb-2008
• 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: EN ISO 8185:1997 - Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)

Relations

• Corrected By: SIST EN ISO 8185:2000/AC:2002 - Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997/Cor.1:2001)
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 8185:2008 - Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
• Effective Date: 01-Apr-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8185:2000
01-januar-2000
Vlažilniki za uporabo v medicini - Splošne zahteve za vlažilne sisteme (ISO
8185:1997)
Humidifiers for medical use - General requirements for humidification systems (ISO
8185:1997)
Anfeuchter für medizinische Zwecke - Allgemeine Anforderungen an
Anfeuchtungssysteme (ISO 8185:1997)
Humidificateurs médicaux - Exigences générales relatives aux systemes d'humidification
(ISO 8185:1997)
Ta slovenski standard je istoveten z: EN ISO 8185:1997
ICS:
11.040.10
SIST EN ISO 8185:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 8185
Second edition
1997-11-15
Humidifiers for medical use — General
requirements for humidification systems
Humidificateurs médicaux — Exigences générales relatives aux systèmes
d'humidification
Reference number
A
ISO 8185:1997(E)

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ISO 8185:1997(E)
Foreword
ISO (the International Organization for Standardization) is a world-
wide 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 organiz-
ations, governmental and nongovernmental, 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.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75% of the member
bodies casting a vote.
International Standard ISO 8185 was prepared by Technical
Committee ISO TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition (ISO
8185:1988), which has been technically revised.
Annexes M, N, P, Q and R form an integral part of this International
Standard. Annexes O, S and T are for information only.
©  ISO 1997
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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ISO ISO 8185:1997(E)
Introduction
Humidifiers are used to raise the water content of gases delivered to
patients. Gases available for medical use do not contain sufficient
moisture and may damage or irritate the respiratory tract or dessicate
secretions of patients whose supraglottic airways have been by-
passed. Heat may be employed to increase the water output of the
humidifier.
In addition, many humidifiers utilize heated delivery tubes in order to
increase operating efficiency and reduce excessive water and heat
loss. Ventilator and anaesthesia delivery tubes in common use may
not withstand the heat generated by humidifiers and heated delivery
tubes mechanisms.
Many humidifier manufacturers use off-the-shelf electrical connectors
for their electrically heated delivery tubes. However, since different
manufacturers have used the same electrical connector for different
power outputs, electrically heated delivery tubes may be physically,
but not electrically, interchangeable. Improper electrically heated
delivery tubes use has caused overheating, circuit melting, patient
and care-giver burns, and fires. Reduction of the relative humidity at
the patient connection port may cause dessication of tracheo-
bronchial secretions (see reference [20], annex T). It was not found
practical to specify the interface requirements for electrical
connectors to ensure compatibility between humidifiers and delivery
tubes produced by different manufacturers.
Since the safe use of a humidifier is dependent on the interaction of
the humidifier with its many accessories, this International Standard
sets total-system performance requirements, including accessories
such as delivery tubes (both heated and nonheated), temperature
sensors, and devices intended to control the environment within
these delivery tubes.
A rationale for the most important requirements is given in annex S.
It is considered that a knowledge of the reasons for the requirements
will not only facilitate the proper application of this International
Standard, but will expedite any subsequent revision.
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INTERNATIONAL STANDARD  ISO ISO 8185:1997(E)
Humidifiers for medical use — General requirements for
humidification systems
Section 1:  General
1.1  Scope
Clause 1 of IEC 60601-1:1988 applies with the following amendment:
ISO 8185 is one of a series of International Standards based on IEC 60601-1; in IEC 60601-1 (the "General
Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3
of IEC 60601-1:1988, the requirements of this International Standard take precedence over those of
IEC 60601-1.
Humidifiers may 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 humidifier system
under consideration.
This International Standard includes requirements for the safety and performance of humidifiers, as defined
in 1.3.107, suitable for inclusion in breathing systems.
This International Standard also includes some requirements for delivery tubes, including heated delivery
tubes (heated-wire delivery tubes), and devices intended to control these heated delivery tubes, heated
delivery tube controllers.
This International Standard is not applicable to heat and moisture exchangers (HMEs).
This International Standard is not applicable to devices commonly referred to as "room humidifiers" and
humidifiers used in heating, ventilation and air conditioning systems, and humidifiers incorporated into
infant incubators.
This International Standard is not applicable to nebulizers used for the delivery of drugs to patients
1.2  Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of
this International Standard. At the time of publication, the editions indicated were valid. All standards are
subject to revision, and parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the standards listed below. Members of
IEC and ISO maintain registers of currently valid International Standards.
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.
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ISO 8185:1997(E)
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals — Part 1: Visual alarm signals.
ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals.
ISO 10524:1995, Pressure regulators and pressure regulators with flow-metering devices for medical gas
systems.
1)
ISO 10651-1:— , Lung ventilators for medical use — Part 1: Particular requirements for critical care
ventilators.
IEC 60079-3:1990, Electrical apparatus for explosive gas atmospheres — Part 3: Spark-test apparatus for
intrinsically-safe circuits.
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.
IEC 60601-1-2:1993, Medical electrical equipment — Part 1: General requirements for safety. 2. Collateral
standard: Electromagnetic compatibility — Requirements and tests.
IEC 60601-2-19:1990, Medical electrical equipment — Part 2: Particular requirements for safety of baby
incubators.
IEC 60801-2:1991, Electromagnetic compatibility for industrial-process measurement and control equip-
ment — Part 2: Electrostatic discharge requirements.
1.3  Definitions
NOTE — Attention is drawn to the definitions given in ISO 4135.
The definitions given in clause 2 of IEC 60601-1:1988 and the following definitions apply.
1.3.101  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.
1.3.102  delivery tube: Tube conveying humidified gas from a humidifier outlet.
NOTE — The delivery tube may be heated.
1.3.103  delivered gas temperature: Temperature of the gas, or aerosol, or both, measured at the patient
connection port.
1.3.104  heated delivery tube controller: Device which controls the heating of a delivery tube.
NOTE — The controller can be either stand-alone or part of the humidifier.
1.3.105  humidification chamber: That part of the humidifier which vaporizes or nebulizes water or water-
based medicament.
1.3.106  humidification system: Delivery tube, heated delivery tube controller (if applicable), humidifier and
any other accessories which when used together are intended to meet the requirements of this International
Standard.

1) To be published. (Revision of ISO 10651-1:1993)
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1.3.107  humidifier: Device to add water in the form of droplets or vapour, or both, to the inspired gas.
NOTE — This term includes vaporizing, bubble-through and ultrasonic humidifiers.
1.3.108  humidifier outlet: Outlet port of the humidifier which delivers the humidified gases.
1.3.109  humidifier 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.
1.3.110  liquid container: That portion of the humidifier which holds the liquid.
NOTE — The liquid container may be detachable for filling.
1.3.111  liquid reservoir: A portion of the humidifier which replenishes the liquid container.
1.3.112  maximum operating pressure: Maximum pressure in the humidifcation chamber.
1.3.113  measured gas temperature: Temperature of the gas, or aerosol, or both, that the humidification
system is measuring and, if applicable, displaying.
1.3.114  operating volume: Volume accessible to the breathing gas of the liquid container when operated
between the maximum and minimum levels, if so marked.
1.3.115  patient connection port: That opening at the patient end of a breathing system intended for
connection to a tracheal or tracheostomy tube connector or adapter, a face mask or a face mask angle-
piece, or a laryngeal mask.
NOTE — For the purposes of this International Standard, for delivery tubes that do not connect directly to a patient (e.g.
tracheal tubes, face masks), the patient end of a delivery tube will be considered the patient connection port.
1.3.116  relative humidity: Water vapour pressure at a particular temperature, expressed as a percentage of
the saturation vapour pressure.
1.3.117  set temperature: Temperature at which the humidifier system attempts to maintain delivered gas
temperature.
NOTE — This temperature may be operator-adjustable.
1.3.118  thermal hazard: Hazard resulting from fire, excessive surface temperature or excessive delivered
gas temperature.
NOTE — Any toxic materials resulting from abnormal temperatures also constitute a thermal hazard. See also annex N.
1.4  General requirements
The requirements given in clause 3 of IEC 60601-1:1988 apply, with the following additions:
3.6 k) Operation of the humidifier without any liquid
3.6 l) 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 temperature control system
3.6 m) A safety hazard (e.g. thermal injury to the patient) resulting from software error.
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1.5  General requirements for tests
The requirements given in clause 4 of IEC 60601-1:1988 apply with the following additions and
modifications:
4.5 a) Modify existing IEC 60601-1:1988 text with the following:
Unless otherwise specified, all tests shall be carried out at ambient conditions according to "b" (see Table 1)
of 23 °C ± 2 °C, RH = 50 % ± 5 % and an atmospheric pressure from 860 hPa to 1060 hPa.
Amend clause 4.6 of IEC 60601-1:1988 as follows:
f) The test gas shall be medical-grade air, medical-grade oxygen, or a mixture of the two.
g) Unless otherwise specified, the liquid container shall be filled at the beginning of a test to the maximum
operating volume with distilled water at the ambient test temperature. The liquid reservoir, if provided,
shall also be filled with distilled water in accordance with the manufacturer's instructions.
h) For the purpose of checking compliance, the measured gas temperature shall be sensed no more than
50 mm from the patient connector port (see also annex N).
1.6  Classification
The requirements given in clause 5 of IEC 60601-1:1988 apply.
1.7  Identification, marking and documents
The requirements given in clause 6 of IEC 60601-1:1988 apply with the following additions and
modifications:
6.1 Marking on the outside of equipment or equipment parts
Amend existing IEC 60601-1:1988 text as follows:
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, in the case of flow-direction sensitive humidifiers or humidification systems;
3) if a pressure-relief mechanism is provided, the pressure over which it opens. This marking shall be on or
near the relief device;
4) if the humidifier is driven by compressed gas, the ranges of the supply flows and pressures that are
required;
5) if the humidifier is intended for use only with patients whose supraglottic airways have not been
bypassed, a warning to indicate that the humidifier is not for use with patients whose supraglottic airways
have been bypassed;
6) if the manufacturer knows of adverse effects on the performance of the humidifier when exposed to, for
example, electrocautery, electrosurgery, defibrillation, X-ray (gamma radiation), infrared radiation,
conducted transients, magnetic fields including magnetic resonance imaging (MRI), and radiofrequency
interference, a warning to, e.g. "See the accompanying documents" for information related to exposure of
this device to, for example, electromagnetic fields.
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6.7 a) Colour of indicator lights
Replace existing IEC 60601-1:1988 text with the following:
Humidifiers and humidification systems for medical use shall met the requirements of ISO 9703-1 and
ISO 9703-2.
6.8 Accompanying documents
Amend 6.8.2 a) as follows:
The Instructions for use shall also include the following information:
1) For humidifiers, at least one delivery tube and other necessary accessories that, when used together with
the humidifier, meet the requirements of this International Standard. In addition, a warning to the effect
that it is potentially unsafe to configure this humidifier with any delivery tube or accessory that is not
specified for use with this humidifier.
For delivery tubes or accessories, at least one humidifier that, when used with the delivery tube or
accessories, will meet the requirements of this International Standard. In addition, a warning to the effect
that it is potentially unsafe to configure this delivery tube or accessory with any humidifier that is not
specified for use with this delivery tube or accessory.
2) If the humidifier includes an integral Venturi mechanism which entrains air for the purpose of diluting
oxygen, the following shall be provided:
a) a statement to the effect that the oxygen concentration may be affected by a partial obstruction
downstream of the humidifier, e.g. the use of accessory equipment;
b) a recommendation that the oxygen concentration be measured at the point of delivery to the patient.
3) The intended use of the humidifier system.
4) If the humidifier is intended for use with patients whose supraglottic airways are bypassed, the
maximum flow and delivered gas temperature that permits a humidifier output of at least 33 mg/l, at a
range of operator control settings.
5) The ranges of operator control settings that result in the gas at a patient connection port having a
relative humidity equal to 100 %.
6) The operating volume and, if provided, the usable volume of the liquid reservoir.
7) If the humidifier is powered by pressurized gas, the recommended ranges of flows or supply pressures
and method(s) of connection.
8) The maximum operating pressure of the humidifier.
9) The pressure drop, as a function of flow, across the humidifier shall be stated. Testing should be in
accordance with ISO 8835-2, or an equivalent method.
10) The gas leakage of the humidifier at the maximum operating pressure.
11) The internal compliance of the humidifier, if the patient's tidal volume can be influenced by inclusion of
the humidifier in the breathing system.
12) The internal compliance of the humidifier at the maximum and minimum operating volumes, if it can be
affected by a change in the volume of liquid in the liquid container.
13) The humidifier output over the humidifier's recommended operating range of gas flows and
temperatures.
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14) The time required (warmup time) for the delivered gas temperature to reach set temperature from a
starting temperature of (23 ± 2) °C when operated according to the manufacturer’s instructions.
15) The circumstances under which the A-weighted sound pressure level exceeds 50 dB measured 1 m
from the device (see 63.2).
16) The maximum delivered gas temperature, if the humidification system is not provided with a means of
continuously indicating the measured gas temperature (see 51.6.1).
17) Identification of all accessories, if the normal use of the humidifier requires a specific accessory (e.g.
heated delivery tubes) in order to meet the requirements of this International Standard.
18) The range of the measured gas temperature which will generate an alarm (see 50.2.4.2).
19) Appropriate warning about operation of the delivery tubes if they may be affected by normal clinical
operation, e.g. covering the tubes with a blanket.
20) The temperature that, when exceeded by the delivered gas temperature, causes the humidification
system to generate a medium-priority alarm. This temperature shall not exceed 41 °C (see 51.6.2).
6.8.2 d)  Cleaning, disinfection and sterilization of parts in contact with the patient
Modify the beginning of 6.8.2 d) as follows:
For reusable equipment parts which come into contact . . .
6.8.3  Technical description
The requirements of clause 6.8.3 of IEC 60601-1:1988 apply with the following amendments:
6.8.3 e) Maximum operating potential
The heated delivery tube controller shall state the maximum operating potential in terms of its mode of
operation (e.g. maximum steady-state voltage and current for electrically heated delivery tubes).
1.8  Power input
The requirements given in clause 7 of IEC 60601-1:1988 apply.
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Section 2:  Environmental conditions
2.1  Basic safety requirements
The requirements given in clause 8 of IEC 60601-1:1988 apply.
2.2  Removable protective means
The requirements given in clause 9 of IEC 60601-1:1988 apply.
2.3  Environmental conditions
The requirements given in clause 10 of IEC 60601-1:1988 apply with the following addition:
10.2.3  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 regulator complying with ISO 10524) it shall
operate and meet the requirements of this International Standard for a pneumatic power supply range
of 280 kPa to 600 kPa and shall not cause a safety hazard under the single fault condition when the
medical gas supply inlet pressure is 1000 kPa.
The requirements given in clause 11 of IEC 60601-1:1988 apply.
The requirements given in clause 12 of IEC 60601-1:1988 apply.
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Section 3:  Protection against electric shock hazards
3.1  General
The requirements given in clause 13 of IEC 60601-1:1988 apply.
3.2  Requirements related to classification
The requirements given in clause 14 of IEC 60601-1:1988 apply.
3.3  Limitation of voltage and/or energy
The requirements given in clause 15 of IEC 60601-1:1988 apply.
3.4  Enclosures and protective covers
The requirements given in clause 16 of IEC 60601-1:1988 apply.
3.5  Separation
The requirements given in clause 17 of IEC 60601-1:1988 apply.
3.6  Protective earthing, functional earthing and potential equalization
The requirements given in clause 18 of IEC 60601-1:1988 apply.
3.7  Continuous leakage currents and patient auxiliary currents
The requirements given in clause 19 of IEC 60601-1:1988 apply, with the following amendment:
19.4 h) Measurement of the patient leakage current
19.4 h) 9) The humidifier connected to the delivery tube and other necessary accessories shall be tested
using metal foil as described under subclause 19.4 g) 5). The metal foil is wrapped around the patient
connection port.
See Figure 25 of IEC 60601-1:1988.
3.8  Dielectric strength
The requirements given in clause 20 of IEC 60601-1:1988 apply.
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Section 4:  Protection against mechanical hazards
4.1  Mechanical strength
The requirements given in clause 21 of IEC 60601-1:1988 apply.
4.2  Moving parts
The requirements given in clause 22 of IEC 60601-1:1988 apply.
4.3  Surface, corners and edges
The requirements given in clause 23 of IEC 60601-1:1988 apply.
4.4  Stability in normal use
The requirements given in clause 24 of IEC 60601-1:1988 apply.
4.5  Expelled parts
The requirements given in clause 25 of IEC 60601-1:1988 apply.
4.6  Vibration and noise
The requirements given in clause 26 of IEC 60601-1:1988 apply.
4.7  Pneumatic and hydraulic power
The requirements given in clause 27 of IEC 60601-1:1988 apply.
4.8  Suspended masses
The requirements given in clause 28 of IEC 60601-1:1988 apply.
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Section 5:  Protection against hazards from unwanted
or excessive radiation
The requirements given in clauses 29-35 of IEC 60601-1:1988 apply.
5.1  Electromagnetic compatibility
The requirements given in clause 36 of IEC 60601-1:1988 apply with the following additions:
36.1 Electromagnetic compatibility
The humidifier system shall continue to function and meet the requirements of this International
Standard or shall fail without causing a safety hazard when tested in accordance with IEC 60601-1-2.
If an anomaly occurs, such as display interruption, false alarm, or loss of function without the integrity
of the associative protective system being compromised, it shall not be considered a safety hazard,
provided it is possible to restore normal operation within 30 s after cessation of the electromagnetic
disturbance.
NOTE: Compliance can be checked by using a worst-case system configuration.
36.2 Protection from electrostatic discharge
Discharges shall be applied only to accessible parts and coupling planes (as defined in IEC 60801-2).
Silencing of an activated alarm shall not be considered a failure.
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Section 6:  Protection against hazards of ignition of flammable
anaesthetic mixtures
6.1  Locations and basic requirements
The requirements given in clause 37 of IEC 60601-1:1988 apply, with the following additions.
37.9 Anaesthetic agents which are ignited by the test in Annex M of this International Standard shall be
regarded as flammable anaesthetic agents.
Humidifiers specified for use with such agents shall be classified and marked as category APG
equipment and shall comply with the requirements of APG equipment in IEC 60601-1:1988.
NOTE: Diethyl ether and cyclopropane are such agents in use.
37.10 Anaesthetic agents which are not ignited by the test in Annex M of this International Standard
shall be regarded as non-flammable anaesthetic agents.
Humidifiers specified for use only with such agents shall comply with subclause 37.11 of this
International Standard.
NOTE: Such an agent in use is halothane
National authorities may decide that test results according to Annex M shall be demonstrated by the
manufacturer of the anaesthetic agent concerned.
37.11 In a humidifier not classified as category APG equipment electrical circuits which may be a
source of ignition under normal condition and single fault condition in enclosed compartments within
which anaesthetic mixtures and oxygen and/or nitrous oxide are produced or used, shall comply with
the requirements of clause 43 of this International Standard.
6.2  Marking, accompanying documents
The requirements given in clause 38 of IEC 60601-1:1988 apply.
6.3  Common requirements for category AP and category APG equipment
The requirements given in clause 39 of IEC 60601-1:1988 apply.
6.4  Requirements and tests for category AP equipment, parts and components thereof
The requirements given in clause 40 of IEC 60601-1:1988 apply
6.5  Requirements and tests for category APG equipment, parts and components thereof
The requirements given in clause 41 of IEC 60601-1:1988 apply
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Section 7:  Protection against excessive temperatures
and other safety hazards
7.1  Excessive temperatures
The requirements given in clause 42 of IEC 60601-1:1988 apply with the following additions:
42.8 The accessible surface temperature within 25 cm of the patient connection port shall not exceed
44 °C.
7.2  Fire prevention
The requirements given in clause 43 of IEC 60601-1:1988 apply, with the following additions:
In order to reduce the risk to patients, other persons or the surroundings due to fire, ignitable material,
under normal and single fault conditions, shall not, at the same time, be subjected to conditions in
which:
— the temperature of the material is raised to its minimum ignition temperature, and
— an oxidant is present.
The minimum ignition temperature is determined in accordance with IEC 6079-4 using the oxidizing
conditions present under the normal and single fault condition.
Compliance is checked by determining the temperature the material is raised to under the normal and
single-fault conditions.
If sparking can occur under normal or single-fault condition, the material subjected to the energy
dissipation of the spark shall not ignite under the oxidizing conditions present.
Compliance is checked by observing if ignition occurs under the most unfavorable combination of
normal conditions with a single fault.
7.3  Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection
The requirements given in clause 44 of IEC 60601-1:1988 apply, with the following modification.
44.2 When the humidifier is tilted through 20° in any direction from its normal operating position, there
shall be no spillage of water from the liquid container or liquid reservoir into the breathing system.
Compliance shall be checked by visual inspection.
7.4  Pressure vessels and parts subject to pressure
The requirements given in clause 45 of IEC 60601-1:1988 apply.
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7.5  Human error
The requirements given in clause 46 of IEC 60601-1:1988 apply.
7.6  Electrostatic charges
The requirements given of clause 47 of IEC 60601-1:1988 apply.
7.7  Materials in applied parts in contact with body of patient
The requirements given in clause 48 of IEC 60601-1:1988 apply.
7.8  Interruption of power supply
The requirements given in clause 49 of IEC 60601-1:1988 apply.
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Section 8:  Accuracy of operating data
and protection against hazardous output
8.1  Accuracy of operating data
The requirements given in clause 50 of IEC 60601-1:1988 apply, with the following additions.
50.1 Marking of controls and instruments
If the humidifier system includes a means of co
...