EN ISO 11196:1997

SLOVENSKI STANDARD
01-januar-2000
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Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)
Überwachungsgeräte für Anästhesiegase (ISO 11196:1995 einschließlich Technisches
Korrigendum 1:1997)
Dispositifs de contrôle de gaz d'anesthésie (ISO 11196:1995 Rectificatif Technique
1:1997 inclus)
Ta slovenski standard je istoveten z: EN ISO 11196:1997
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL
ISO
STANDARD
First edition
1995-1 O-l 5
Anaesthetic gas monitors
Dispositifs de con tr6le de gaz d ‘anesthksie
Reference numbea
ISO 11196:1995(E)
ISO 11196:1995(E)
Contents
Page
General
Section 1
. . . . . . . . . . . . .
1.1 Scope
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . “.~. “.
1.2 Normative references . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Definitions
. . . 4
1.4 General requirements and general requirements for tests
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Classification
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Identification, marking and documents
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Power input
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Environmental conditions
Section 2
........................................................ 10
Basic safety categories
2.1
.............................................. IO
2.2 Removable protective means
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 Environmental conditions
.,.
Section 3 Protection against electric shock hazards
........................... 11
3.1 General .
...... ........................... 11
Requirements related to classification
3.2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Limitation of voltage and/or energy
. .*. .*. 11
3.4 Enclosures and protective covers
3.5 Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Protective earthing, functional earthing and potential
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
equalization
. . 11
3.7 Continuous leakage current and Patient auxiliary currents
............................. ............................. 11
3.8 Dielectric strength .
. . . . . . . . . . . . . . . . . .
Section 4 Protection against mechanical hazards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.1 Mechanical strength
........ ................................................................
4.2 Moving Parts
0 ISO 1995
All rights reserved. Unless otherwise specified. no part of this publication may be reproduced
or utilized tn any form or by any means, electronie or mechanrcal, including photocopying and
mrcrofilm, without permission in writing from the publisher.
International Organrzatlon for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Pnnted rn Swrtzerland
0 ISO
ISO 11196:1995(E
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3 Surface, corners and edges
4.4 Stability in normal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Expelled Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6 Vibration and noise
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.7 Pneumatic and hydraulic power
4.8 Suspended masses . . . . . . . . . . . . . .*.
Section 5 Protection against hazards from unwanted or excessive
radiation . . . . . . . . . .*.*. 13
5.1 X-radiation .*.*. 13
5.2 Alpha, beta, gamma, neutron radiation and other particle
radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3 Microwave radiation
5.4 Light radiation (including lasers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.5 Infrared radiation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.6 Ultraviolet radiation
. . . . . . . . . . . . . . . . . . . . . . . . . .p. 13
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetit compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section 6 Protection against hazards of ignition of flammable
anaesthetic mixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1 Locations and basic requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.2 Marking, accompanying documents
6.3 Common requirements for categories AP and APG equipment 14
6.4 Requirements and tests for category AP equipment, Parts and
components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.5 Requirements and tests for category APG equipment, Parts and
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
components
Protection against excessive temperatures and other
Section 7
. . . . . . . . . . . . . . . . . . . . . .“. 15
safety hazards
7.1 Excessive temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.2 Fire prevention . . 15
7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.4 Pressure vessels and Parts subject to pressure . . . . . . . . . . . . . . . . . a 15
“.,,.rn. . . . . . . . . . .“.“.m.n 16
7.5 Human errors
.......................................... ..................
7.6 Electrostatic charges 16
0 ISO
ISO 11196:1995(E)
7.7 Materials in applied Parts in contact with body of Patient
. . 16
7.8 Interruption of power supply
........................... ..................... 16
Section 8
Accuracy of operating data and protection against
hazardous output . 17
8.1 Accuracy of operating data
.................................................. 17
8.2 Protection against hazardous output
.................................... 17
Section 9 Abnormal Operation and fault conditions; environmental
tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 21
9.1 Abnormal Operation and fault conditions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9.2 Environmental tests
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Section 10 Constructional requirements
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.1 General
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.2 Enclosures and covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Components and general assembly
10.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.4 Main park, components and layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.5 Protective earthing - Terminals and connections . . . . . . . . . . . 22
10.6 Construction and layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Section 11 Additional requirements specific to anaesthetic gas
monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*. 23
11.1 Interfering gas and vapour effects tother than water vapour)
11.2 Obstruction of sampling tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11.3 Breathing System connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11.4 Contamination of breathing Systems
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Annexes
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Ato L
Test of anaesthetic agents for non-flammability . . . . . . . . . . . . . . . . . . . . . . . 26
IM
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
N Rationale
P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Bibliography
0 ISO
ISO 11196:1995(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. Esch 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 patt 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 International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard ISO 1 ‘l196 was prepared by Technical Committee
ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 1, Breathing attachments and anaesthetic machines.

0 ISO
ISO 11196:1995(E)
Introduction
The measurement of the concentration of inhalation anaesthetic gases is
becoming common practice. This International Standard establishes re-
quirements for anaesthetic gas monitors that are achievable within the
limits of existing technology.
Calibration gases (i.e. gases with accurate molar concentrations of anaes-
thetic agents) generated by gravimetric methods defined in ISO 6142 are
directly traceable to national mass Standards.
Such gases may be used
to calibrate anaesthetic gas monitors directly, or
d
b) to calibrate intermediate methods used to verify secondary calibration
gases which are then used to calibrate anaesthetic gas monitors.
For example, such intermediate methods may be the use of refractometry,
mass spectrometry, etc.
Annex N contains rationales for the most important requirements and is
included to provide additional insight for the reasoning that led to the re-
quirements and recommendations that have been incorporated in this
International Standard.
INTERNATIONAL STANDARD 0 ISO ISO 11196:1995(E
Anaesthetic gas monitors
Section 1: General
1.1 Scope
NOTE 1 See the rationale in annex N.
ISO 11196 is one of a series of International Standards based on IEC 601-1; in IEC 601-1 (the “General
Standard ”), this type of International Standard is referred to as a “Particular Standard ”. As stated in 1.3 of
IEC 601-1 :1988, the requirements of this International Standard take precedence over those of IEC 601-1.
The scope and Object given in clause 1 of IEC 601-1:1988 apply except that 1.1 shall be replaced by the following:
This International Standard specifies requirements for anaesthetic gas monitors intended for use in determining
the anaesthetic vapour and/or gas IeveI(s) in breathing gas mixtures and/or fresh gas mixtures. Both diverting and
non-diverting anaesthetic gas monitors are covered, irrespective of the measuring technology used. Also included
are anaesthetic gas identifying monitors. The field of application includes monitoring Patient breathing mixtures,
the output of anaesthesia workstations, and the output of vaporizers as well as anaesthesia Ventilators and
breathing Systems.
Anaesthetic gas monitors intended for use in laboratory research, non-human applications or for calibration of an-
aesthetic agent vaporizers are outside the scope of this International Standard.
Anaesthetic gases addressed in this International Standard include, but are not limited to, halothane, enflurane,
isoflurane, sevoflurane, desflurane and nitrous Oxide.
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 possi-
bility of applying the most recent editions of the Standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
ISO 32: 1977, Gas cylnders for medical use - Marking for identification of content.
ISO 4135: 1995, Anaesthesiology - Vocabulary.
ISO 5356-1 :1987, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
ISO 5359: 1989, Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas
sys tems.
ISO 11196:1995(E)
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.
Part 3: Spark test apparatus for
IEC 79-3:1990, Electrical apparatus for explosive gas atmospheres -
in trinsically-safe circuits.
- Part 4: Me thod of test for ignition temper-
I EC 79-4: 1975, Electrical apparatus for explosive gas atmospheres
a ture.
I EC 601-1: 1988, Medical electrical equipment - Part 7: General requirements for safety.
I EC 601-1-2: 1994, MedicaI e/ectrica/ equipment - Part 7: General requirements for safety - Collateral Standard
- Electromagnetit compatibility requirements and tests.
I EC 80 l-2: 199 1, Electromagne tic compa tibility for indus trial process measurement and control equipment -
Elec tros ta tic discharge requiremen ts.
1.3 Definitions
For the purposes of this International Standard, the definitions given in clause 2 of IEC 601-1 :1988 and ISO 4135,
and the following definitions apply.
1.3.1 alarm Set-Point: Setting of the adjustment control, or display value which indicates the anaesthetic gas
reading, at or beyond which the alarm is intended to be activated.
NOTE 2 Terms such as “alarm Iimits” or “alarm threshold” are frequently used to describe the same function.
1.3.2 alarm System: Those Parts of the anaesthetic gas monitor which
establish the alarm Set-Point(s);
a)
activate an alarm when the anaesthetic gas reading is less than or equal to the low alarm Set-Point, if provided,
b)
or is equal to or greater than the high alarm Set-Point.
1.3.3 anaesthesia workstation: System for administration of anaesthesia which includes, but is not limited to,
an anaesthetic gas delivery System, its essential monitoring devices, and essential hazard protection devices.
1.3.4 anaesthetic gas monitor: Device for the measurement of the anaesthetic gas level in anaesthetic gas
mixtures.
1.3.5 anaesthetic gas: Gas and/or vapour of a volatile agent used in anaesthesia.
1.3.6 anaesthetic gas level: Concentration in volume percent or partial pressure of anaesthetic gas in a gaseous
mixture.
1.3.7 anaesthetic gas reading: Measured anaesthetic gas level as indicated by the anaesthetic gas monitor
display.
1.3.8 applied Part: Part of the anaesthetic gas monitor intended to be connected with the Patient or with the
anaesthetic breathing system. ‘)
1.3.9 delay time: Time from a step function Change in anaesthetic gas level at the sampling site to the
achievement of IO % of the step Change in the anaesthetic gas reading of the anaesthetic gas monitor (see
figure 1).
1) See the rationale in Annex N.
ISO 11196:1995(a
c
a
c
s
f
U
a
aJ
t
Ul 50
t
t
c
s 20
c
t
t
-
IO
Time
-
Figure 1 - Delay time, rise time and total System response time
1.3.10 display: Visual representation of output data.
1.3.11 diverting anaesthetic gas monitor: Anaesthetic gas monitor that transports a Portion of ventilatory
gases from the sampling site through a sampling tube to the Sensor, which is remote from the sampling site.
1.3.12 fresh gas outlet; common gas outlet: That port through which the dispensed mixture from an anaes-
thetic apparatus is delivered to a breathing System.
1.3.13 enabled condition: Necessary, but not sufficient, condition to Cause an action.
default conditions; default settings: Those operating Parameters within the monitor, which are pre-set
1.3.14
at the factory or by the Operator and which the monitor itself Sets, without further intervention, when it is turned
on.
1.3.15 interference with measurement accuracy: Differente between the anaesthetic gas readings in the
presence and absence of an interfering gas(es).
1.3.16 non-diverting anaesthetic gas monitor: Anaesthetic gas monitor that uses a Sensor at the sampling site.
1.3.17 partial pressure: Pressure that each gas in a gas mixture would exert if it alone occupied the volume of
the mixture at the same temperature.
1.3.18 volume percent; % (VW): Volume of an anaesthetic or other gas in a mixture, expressed as a percent
of the total volume.
1.3.19 rise time: Time required to display a rise from IO % to 90 % of the Change in the anaesthetic gas reading
by the anaesthetic gas monitor when a step function Change in anaesthetic gas level occurs at the sampling site
(see figure 1).
0 ISO
ISO 11196:1995(E)
1.320 sampling site: Location at which Ventilator-y gases are diverted for measurement to a remote Sensor in
a diverting anaesthetic gas monitor or the location of the Sensor area in a non-diverting anaesthetic gas monitor.
tube: Conduit for transfer of gas from the sampling site to the Sensor in a diverting anaesthetic
1.3.21 sampling
gas monitor.
1.3.22 Sensor: Part of the anaesthetic gas monitor which is sensitive to the presence of the anaesthetic gas.
1.3.23 total System response time: Sum of the delay time and rise time (see figure 1).
1.3.24 anaesthetic Ventilator: Actuator device of an anaesthesia workstation which, when connected to the
patient ’s airway, is designed to augment or provide Ventilation of the patient ’s lungs.
1.3.25 accuracy: Quality which characterizes the ability of a device to give indications approximating to the true
the quantity measured.
value of
Accuracy is an overall quality of a device from the Point of view of errors. Accuracy is greater when the indications
NOTE 3
are closer to the true value (based on ISO 7504:1984).
drift: Change of the indications of a monitor, for a given
1.3.26 ievel of concentration over a stated period of time,
under reference conditions which remain constant.
4 to distinguish the zero drift which concerns the Operation of the instrument with samples of zero
NOTE lt is necessary
concentration from the drift considered at one or several levels of concentration (based on ISO 7504:1984).
or low
1.3.27 flammable anaesthetic agent: Anaesthetic agent which is ignited by the test specified in annex M.l)
1.3.28 non-flammable anaesthetic agent: Anaesthetic agent which is not ignited by the test specified in
annex M.l)
1.3.29 respiratory gas conducting components: All components of the anaesthetic Ventilator and the anaes-
thetic breathing System which are in contact with the patient ’s inhaled gas during any form of Ventilation.
NOTES
5 Such components are for example anaesthetic breathing Systems, anaesthetic breathing System attachments, Ventilator
bellows, particle filters, APL valves and CO, absorber assemb ilies.
6 When t he s Iample gas i s not returned to the anaesthetic breathing System, the gas sampling line is not considered to be a
re spiratory conducting component.
gas
1.4 General requirements and general requirements for tests
The requirements given in clauses 3 and 4 of IEC 601-1 :1988 apply with the following additions?
All Parts of an anaesthetic gas monitor and their devices should be designed and manufactured to minimize health
risks due to toxic products and substances leached from the devices during use.
3.6 j) Applicable Single fault conditions are:
short- and open-circuits of components or wiring which tan
a)
- Cause Sparks to occur, or
- increase the energy of Sparks, or
- increase the temperature (see section 7);
b) incorrect output resulting from Software error.
3.6 k) An oxidant leak which remains undetected shali be considered a normal condition and not a Single fault
condition?
0 ISO
ISO 11196:1995(1
3.10 Devices dependent on Software shali be designed in such a way as to minimize the possibility of risks
arising from errors in the Software.
4.12 Test methods other than those specified in this international Standard but of equal or greater accuracy
may be used to verify compliance with the requirements of this International Standard. However, in the event
of dispute, the methods specified in this international Standard shall be used as the reference methods.
1.5 Classification
The requirements given in clause 5 of IEC 601-1 :1988 appiy with the following addition.
NOTE - An anaesthetic gas monitor may have applied Parts of different types.
1.6 Identification, marking and documents
The requirements given in clause 6 of IEC 601-1:1988 apply together with the following amendments and addi-
tions.
6.1 i, Amend existing IEC 601-1 :1988 text to read
The rated input shall be given in amperes for the anaesthetic gas monitor and for the sum of the current
ratings for the anaesthetic gas monitor and the auxiliary mains socket outlet(s)?
6.1 k) Amend existing IEC 601-1 :1988 text to read
Esch auxiliary mains socket outlet shail be marked with the maximum allowed output, which shall be given
in amperes?
After 6.1 z), add the following:
6.1 aa) All operator-connectable components of the anaesthetic gas monitor which are flow-direction-sensitive
shail be clearly and durabiy marked with an arrow showing the direction of gas flow.
6.1 ab) Esch gas-specific inlet and outlet shall be identified by ciear and durabie marking using the gas name
or Chemical Symbol in accordance with ISO 5359. If colour coding is used in addition, it shall be in accordance
with ISO 32.
6.1 ac) Marking of packages.
Packages containing respiratory gas-conducting components shall be permanently and legibly marked with the
following:
information about cleanliness and sterility of Single use and reusable components as supplied by
1)
the manufacturer;
an indication of the time limit for using a device safely expressed in yearlmonth, where applicable;
2)
a description of the contents;
3)
4) the name and/or trademark of the manufacturer and/or supplier;
an identification reference to the type, batch or seriai number;
5)
6) the necessary instructions in the event of the sterile pack being damaged and, where appropriate,
details of appropriate methods of steriiization;
if appropriate the words “SINGLE USE” or “SINGLE PATIENT USE ”;
NOTE - Symbol No. 1051 ( “DO not re-use ”) given in ISO 7000:1989 may additionally be used.
the word “STERILE ”, and the method of sterilization, if applicabie. Device packing andlor labeiling
shall differentiate between the Same or simiiar products both sterile and non-sterile placed on the
market by the Same manufacturer.
PS0 11196:1995(E)
6.1 ad) Marking of anaesthetic gas monitors
Anaesthetic gas monitors shall be durabiy and legibly marked with the following:
any particular instructions for use;
1)
any particular warnings and/or cautions;
2)
if a sampled gas inlet and outlet are present on the anaesthetic gas monitor, marking of the ports;
3)
if the device is intended oniy for use with dry fresh-gas mixtures, a Statement to that effect;
4i
serial number and year of manufacture;
5)
NOTE - The year of manufacture may be part of the serial number.
6) if not suitable for use in breathing Systems, a Statement to that effect.
6.2 Marking on the inside of equipment or equipment Parts.
The requirements given in clause 6.2 of IEC 601-1 :1988 apply.
6.3 Marking of controls and instruments.
The requirements given in clause 6.3 of IEC 601-1 :1988 apply with the following additions.
6.3 g) If an anaesthetic gas monitor has more than one sampling site, the selection of a particular sampling site
shall be clearly indicated on the anaesthetic gas monitor;
6.3. h) If a display or a calibrated scale or controi measures or controls a variable within the anaesthetic gas
monitor,
1) the display or scaie shall be marked to indicate that it refers to a machine variable and not a Patient
variable,
anaesthetic gas reading display(s) shall be marked with kPa (partial pressure) or % (VW) (volume
2)
percent) anaesthetic gas,
if abbreviations for anaesthetic agents are used, they shall be in compliance with coiumn 2 of table
3)
1.
Compliance shail be determined by inspection of marking and instructions for use.
Table 1 - Abbreviations for anaesthetic agents
Anaesthetic agent Abbreviation
r
Desflurane DES or D
Enflurane ENF or E
Halothane HAL or H
ISO or I
Isoflurane
Methoxyflurane MET or M
SEV or S
Sevofluranelj
1) Provisional.
6.4 Symbols.
The requirements given in clause 6.4 of IEC 601-111988 apply.
6.5 Colours of insuiation of conductors.

0 ISO ISO 11196:1995(1
The requirements given in clause 6.5 of IEC 601-1 :1988 apply.
6.6 Identification of medical gas cylinders and connections.
The requirements given in clause 6.6 of IEC 601-1 :1988 apply.
6.7 Indicator lights and push-buttons.
The requirements given in clause 6.7 a) of IEC 601-1 :1988 apply with the foilowing modification.
On equipment, the colour red shall be used exclusively to indicate a warning of danger and/or a need for urgent
action. Dot matrix, aiphanumeric displays and computer-generated graphics are not considered to be indicator
iights.
6.8 Accompanying documents.
6.8.1 General.
The requirements given in clause 6.8.1 of IEC 601-1 :1988 apply.
6.8.2 Instructions for use.
The requirements given in clause 6.8.2 of IEC 601-1:1988 apply with the following additions.
6.8.2 a) General information.
- If gas diversion occurs, the range of gas diversion flows shall be given.
- If appropriate, a Statement that equipment may be used in a magnetic resonance imaging (MN) environ-
ment shall be given.
- instructions for proper disposai of the diverted gas shall be provided.
case of divet-ting anaesthetic gas monitors,
- Delay time and rise time (see figure 1) shall be disclosed. in the
disclosed.
the sampling tube(s) used in determining these values shali be
Instructions for use shall contain the conditions under which measured values are displayed, for example am-
bient temperature and pressure saturated (ATPS), body temperature and pressure saturated (BTPS), Standard
temperature and pressure dry (STPD).
6.8.2 i) The instructions for use of category APG anaesthetic gas monitors shall iriclude Statements to the ef-
fett of the following.
- This anaesthetic gas monitor has been constructed to comply with the requirements for category APG
equipment.
- Any modification to the anaesthetic gas monitor may compromise its safety in the presence of flammable
anaesthetic agents.
- Provided that the following precautions are strictiy observed, this anaesthetic gas monitor is safe to use
with fiammable anaesthetic agents such as diethyi ether and cyclopropane.
The discharge of flammable anaesthetic agents or mixtures while the anaesthetic breathing System
‘1)
is disconnected is to be avoided.
Only equipment classified and marked AP@ should be used within 5 cm of any Point of possibie
2)
emission of flammabie anaesthetic agents or mixtures.
Only equipment classified and marked as AP or APG shouid be used within 25 cm of any Point of
3)
possibie emission of flammable anaesthetic agents.

0 ISO
ISO 11196:1995(E)
6.8.2 k) The instructions for use of anaesthetic gas monitors marked as APG but having Parts which are not
category APG shall inciude full information to identify such parts?
6.8.2 1) The instructions for use of category APG anaesthetic gas monitors shali include a warning Statement
to the effect of the foiiowing.
When using agents forming flammable mixtures, only antistatic or electrically conductive components shall
be used in the anaesthetic breathing System. This does not appiy to tracheal tubes, tracheai tube connectors
and oropharyngeai airways?
6.8.2 m) The instructions for use of anaesthetic gas monitors not specified as category APG equipment shall
include a Statement to the effect of the foilowing.
To avoid expiosion hazards, flammable anaesthetic agents such as ether and cyc opropane shall not be used
in this anaesthetic gas monitor. Oniy anaesthetic agents which comply with the requirements on non-
flammable anaesthetic agents in this International Standard are suitable for I se in this anaesthetic gas
monitor?
6.8.2 n) The instructions for use of anaesthetic gas monitors not specified as cc tegory APG shall include a
Statement to the effect of the foiiowing.
The use of antistatic or eiectricaiiy conductive breathing tubes when utiiizing high-frequency electrosurgery
equipment may increase the risk of burns and is therefore not recommended in any application of this an-
aesthetic gas monitor?
6.8.2 o) The instructions for use shaii contain information about cieanliness and sterility upon deiivery for Single
use and re-usable components, where applicable.
6.8.2 p) Information about monitoring, alarm and protection modules.
The instructions for use shail contain:
a description of the methods of verifying alarm functions;
details of any pressure relief valves fitted to the anaesthetic gas monitor that tan affect the
breathing System;
details of default alarm Set-Points and priorities.
6.8.2 q) The instructions for use shall include information about the connection of an anaesthetic gas scav-
enging System (AGSS) and/or return of the diverted gases to the breathing System.
6.8.3 Technicai description.
The requirements given in clause 6.8.3 of IEC 601-1 :1988 apply with the following amendments.
6.8.3 a) The technicai description shaii additionally include the foliowing information.
a) General
The requirements given in ciause 6.8.3 a) of IEC 601-1 :1988 appiy with the following additions.
- The technical description shall give accuracies, dispiay resolutions and ranges of dispiayed vaiues and
caiibrated controls.
Accuracies should be expressed as maximum zero
error (bias) quoted directly in appropriate units plus
a sensitivity error (linearity, precision), for example,
quoted as a percentage of the reading.
- interdependente of controls, if applicable, shall be disclosed.
ISO 11196:1995(i
- The ambient air ingression and internal gas leakage, if any, shall be disciosed.
- Information necessary to check that an anaesthetic gas monitor is installed correctly and is in safe and
correct working Order and on the nature and frequency of maintenance operations necessary to ensure
continuing safety and correct Operation shall be disclosed.
1.7 Power input
The requirements given in clause 7 of IEC 601-1:1988 apply.

ISO 11196:1995(E)
Section 2: Environmental conditions
2.1 Basic safety categories
The requirements given in clause 8 of IEC 601-1 :1988 apply.
2.2 Removable protective means
The requirements given in clause 9 of IEC 601-1: 1988 apply.
2.3 Environmental conditions
The requirements given in ciause 10 of IEC 601-1 :1988 appiy.
ISO 11196:1995(~
Section 3: Protection against electric shock hazards
3.1 General
The requirements given in clause 13 of IEC 601-1 :1988 appiy.
3.2 Requirements related to classification
The requirements given in clause 14 of IEC 601-1 :1988 apply.
3.3 Limitation of voltage and/or energy
The requirements given in clause 15 of IEC 601-1 :1988 apply.
3.4 Enclosures and protective covers
The requirements given in clause 16 of IEC 601-1 :1988 apply.
3.5 Separation
The requirements given in ciause 17 of IEC 601-1 :1988 appiy with the following additions.
17 h) Deterioration of Parts due to Oxygen shali be taken into account.
Compliance is checked by inspection, by measurements and/or test according to subclause 59.2 c) of
IEC 601-1:1988.
17 j) Deterioration of Parts due to anaesthetic agents shali be taken into account.
Compliance is checked via manufacturer certification.
3.6 Protective earthing, functional earthing and potential equalization
The requirements given in clause 18 of IEC 601-1 :1988 apply.
3.7 Continuous leakage current and Patient auxiliary currents
The requirements given in ciause 19 of IEC 601-1:1988 apply with the following addition.
19.4 h) Measurement of the Patient leakage current?
Addition:
19.4. h) 12) The Patient leakage current shail be measured from Parts which are defined as applied Parts
for the purposes of this international Standard. All these Parts shall be connected together eiectrically with
the exception of Parts connected to the protective earth terminal which shall be tested separateiy from Parts
not so connected.
3.8 Dielectric strength
The requirements given in ciause 20 of BEC 601-111988 appiy.
ISO 11196:1995(E)
Section 4: Protection against mechanical hazards
4.1 Mechanical strength
The requirements given in clause 21 of IEC 6Ol-1:1988 apply.
4.2 Moving Parts
The requirements given in clause 22 of IEC 601-1 :l988 apply.
4.3 Surface, corners and edges
The requirements given in clause 23 of IEC 601-1:1988 apply.
4.4 Stability in normal use
The requirements given in clause 24 of IEC 601-1 :1988 apply.
4.5 Expelled park
The requirements given in clause 25 of IEC 601-1 :1988 apply.
4.6 Vibration and noise
The requirements given in clause 26 of IEC 601-1 :1988 apply with the following addition.
Vibration and noise shall be limited to non-hazardous levels.
4.7 Pneumatic and hydraulic power
The requirements given in clause 27 of IEC 601-1 :1988 apply.
4.8 Suspended masses
The requirements given in clause 28 of IEC 601-1 :1988 apply.
ISO 11196:1995~,
Protection against hazards from unwanted or excessive
Section 5:
radiation
5.1 X-radiation
The requirements given in clause 29 of IEC 601-1 :1988 apply.
5.2 Alpha, beta, gamma, neutron radiation and other particle radiation
The requirements given in clause 30 of IEC 601-1 :1988 apply.
5.3 Microwave radiation
The requirements given in clause 31 of IEC 601-1 :1988 apply.
5.4 Light radiation (including lasers)
The requirements given in clause 32 of IEC 601-1:1988 apply.
5.5 Infrared radiation
The requirements given in clause 33 of IEC 601-1 :1988 apply.
5.6 Ultraviolet radiation
The requirements given in clause 34 of IEC 601-1 :1988 apply.
5.7 Acoustical energy (including ultrasonics)
The requirements given in clause 35 of IEC 601-1 :1988 apply. See also 1.6, “6.8.2 p) “.
5.8 Electromagnetit compatibility
Replace the requirements given in clause 36 of IEC 601-1 :1988 with the following.
36.1 Electromagnetit compatibility.
The anaesthetic gas monitor shall continue to function and meet the requirements of this International Standard
or shall not Cause a safety hazard when tested in accordance with IEC 601-1-2.
36.2 Protection from electrostatic discharge.
Discharges shall be applied only to accessible Parts and coupling planes (as defined in IEC 801-2).
If an anomaly occurs, such as display interrupt, alarm activation, etc., it shall be possible to restart normal op-
eration within 30 s after the electrostatic discharges have been applied.
Silencing of an activated alarm should not be considered a failure.
0 ISO
ISO 11196:1995(E)
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 601-1 :1988 apply with the following additional subclauses.
37.9 Anaesthetic agents which are ignited by the test in annex M shall be regarded as flammable anaesthetic
agents?
Anaesthetic gas monitors specified for use with such flammable agents shall be classified and marked as cat-
egory APG equipment and shall comply with the requirements of APG equipment in IEC 601-1 :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 shall be regarded as non-flammable
anaesthetic agents?
Anaesthetic gas monitors specified for use only with such non-flammable agents shall comply with 7.2, “43 ”.
NOTE - Such an agent in use is halothane.
6.2 Marking, accompanying documents
The requirements given in clause 38 of IEC 601-1 :1988 apply.
6.3 Common requirements for categories AP and APG equipment
The requirements given in clause 39 of IEC 601-1 :1988 apply, with the following additions.
39.3 k) An anaesthetic gas monitor specified and marked as APG shall provide a continuous current path for
electrostatic charges from the applied part to earth with a resistance less than 1 MW)
Compliance is checked by the following test:
The resistance shall be measured between the applied Part(s) and, in turn,
- a conductive plate on which the anaesthetic gas monitor is placed,
- any protective earth terminal,
- any terminal for potential equalization conductor.
6.4 Requirements and tests for category AP equipment, Parts and components
The requirements given in clause 40 of IEC 601-1 :1988 apply.
6.5 Requirements and tests for category APG equipment, Parts and components
The requirements given in clause 41 of IEC 601-1 :1988 apply.
0 ISO
ISO 11196:1995(L
Protection against excessive temperatures and other safety
Section 7:
hazards
7.1 Excessive temperatures
The requirements given in clause 42 of IEC 601-1 :1988 apply.
7.2 Fire prevention
The requirements given in clause 43 of IEC 601-1:1988 apply with the following additional subc1ause.l)
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 79-4 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 condition.
normal or su bjected to the energy dissipation
If sparking tan occur under Single fault conditions, the material
of the spark shall not ignite under the oxidizing conditions present.
Compliance is checked by observing if ignition occurs under the most unfavourable 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 601-1 :1988 apply with the following addition.
44.7
44.7.1 In Order to minimize the risk of infection PO the Patient from respiratory gas conducting components,
all manufacturer-specified reusable components which come into contact with the respiratory gas shall be
sterile or disinfected, or sterilizable or disinfectable, or be provided with a microbial filter.
44.7.2 If a Claim is made in the labelling that the device is sterile, it shall have been sterilized using an ap-
propriate validated method.
44.7.3 Non-sterile device packaging Systems shall be designed to maintain products which are intended to
be sterilized before use at the intended Ievel of cleanliness
...