Oxygen monitors for monitoring patient breathing mixtures — Safety requirements

Analyseurs d'oxygène pour le contrôle des mélanges gazeux respirés par le patient — Exigences de sécurité

General Information

Status
Withdrawn
Publication Date
23-Apr-1997
Withdrawal Date
23-Apr-1997
Current Stage
9599 - Withdrawal of International Standard
Completion Date
17-Nov-2004
Ref Project

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ISO 7767:1997 - Oxygen monitors for monitoring patient breathing mixtures -- Safety requirements
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IS0
INTERNATIONAL
7767
STANDARD
Second edition
1997-05-01
Oxygen monitors for monitoring patient
breathing mixtures - Safety requirements
Analyseurs d’oxyghe pour le contr6le des mklanges gazeux respirks par le
patient - Exigences de skcurith
Reference number
IS0 7767: 1997(E)

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IS0 7767:1997( E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of national standards
bodies (IS0 member bodies). The work of preparing International Standards is normally carried out
through IS0 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. IS0
collaborates closely with the International Electrotechnical Commission(lEC) 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 IS0 7767 was prepared by Technical Committee lSO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee 3, Lung ventilators and ’ related equipment.
(IS0 7767:1988), which has been technically
This second edition cancels and replaces the first edition
revised.
Annex N forms an integral part of this International Standard. Annexes 0 and P are for information only.
0 IS0 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 l CH-1211 Geneve 20 l Switzerland
Internet central @ iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii

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IS0 7767: 1997(E)
@ IS0
Introduction
IS0 7767 is one of a series of standards developed for specific medical electrical equipment (a Particular
Standard) based on IEC 601-1:1988, Medica/ electrica/ equipment - Part 7; Genera/ requirements for safety
(The General Standard). IS0 7767:1988 referenced the first edition of IEC 601-I published in 1977 and this
International Standard references the second edition, published late in 1988.
Annex 0 provides a rationale for specific requirements.

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IS0 7767: 1997(E)
INTERNATIONAL STANDARD @ IS0
Section 1: General
1.1 Scope
IS0 7767 is one of a series of International Standards based on IEC 601-I (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-I.
The scope given in clause 1 of IEC 601-I:1988 applies except that 1.1 shall be replaced by the
following:
This International Standard specifies safety requirements for oxygen monitors, as defined in
clause 1.3.14, intended for use in determining the oxygen level in gas mixtures. Both diverting
and non-diverting oxygen monitors are covered.
The field of application includes, but is not limited to:
anaesthetic machines and breathing systems;
a)
W ventilators;
d infant incubators;
oxygen concentrators.
d)
Devices that do not “measure and indicate” are not intended to be covered by this International
Standard. For instance, a device that has no function other than to signal an alarm at a specific
oxygen level would not be considered to be an oxygen monitor for use in direct patient
monitoring applications.
The phrase “in a gaseous mixture” implies that devices that measure or monitor oxygen in a
liquid phase (for example, blood gas analyzer or indwelling catheters) are not covered by this
International Standard.
Oxygen monitors intended for use in laboratory research applications are outside the scope of
this International Standard.
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 agreement based on this
International Standard are encouraged to investigate the possibility of applying the most recent
edition of the standards listed below:
IS0 5356-l :1996, Anaesthetic and respiratory equipment - Conical connectors - Part 7: Cones
and sockets.
IS0 5356-2:1996, Anaesthetic and respiratory equipment -Conical connectors - Part 2: Screw-
threaded weight-bearing connectors.
IS0 9703-I :1992, Anaesthesia and respiratory care alarm signals - Part 7: Visual alarm signals.

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IS0 7767: 1997(E)
IS0 9703-2:1994, Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm
signals.
IEC 79-3: 1990, Electrical apparatus for explosive gas atmospheres - Part 3: spark test apparatus
for explosive gas atmospheres.
IEC 79-4:1975, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for
ignition temperature.
IEC 601-I :1988, Medical electrical equipment - Part 7: General requirements for safety.
Part 7: General requirements for safety.
IEC 601-l-2:1993, Medica/ electrical equipment -
2. Collateral standard: Electromagnetic compatibility - Requirements and tests.
1.3 Definitions
For the purposes of this International Standard, the definitions given in clause 2 of
IEC 601-I:1988 apply, together with the following definitions.
1.31.4 alarm: Warning signal of an alarm system.
I.312 alarm set-point: Setting of the adjustment control or display value which indicates the
oxygen level at or beyond which the alarm is intended to be activated (indicated alarm
limit).
set
1.3.3 alarm system: Those parts of the oxygen monitor which a) establish the alarm
ow
point(s); b) activate an alarm when the oxygen level is less than or equal to the
alarm set-point, or is equal to or greater than the high alarm set-point.
1.3.4 default (alarm or setting): Those operating parameters within the system which are
preset at the factory or by the operator and which the system itself sets, without further
intervention, when it is turned on.
1.3.5 delay time: With respect to a step change in oxygen concentration or partial pressure at
the sampling site, the time required for the monitor to register IO % of the step change.
1.3.6 display: Device that visually indicates quantitative or qualitative information.
1.3.7 diverting oxygen monitor: Oxygen monitor which transports the gas mixture from the
sampling site to the sensing area.
1.3.8 expected service life: Period during which the performance of an oxygen monitor or
any of its components is expected to meet the requirements of this International
Standard when used and maintained according to the accompanying documents.
I .3.9 high priority alarm: Combination of auditory and visual signals indicating that
immediate operator response is required.
1.3.10 interference with measurement accuracy: Difference between the oxygen reading in the
presence of an interfering gas mixture and the oxygen reading in a corresponding
mixture in which the interfering gas or vapour fraction has been replaced by nitrogen.

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IS0 7767: 1997(E)
1.3.11 low priority alarm: Visual signal, or combination of auditory and visual signals,
indicating that prompt operator response is required.
1.3.12 medium priority alarm: Combination of auditory and visual signals indicating that
prompt operator response is required.
1.3.13 oxygen level: Concentration of oxygen in a gaseous mixture expressed as volume
fraction in percent (V/v) or as partial pressure (in kilopascals).
1.3.14 nitor: Device that measures and indicates the oxygen level in a gaseous
oxygen
mixture.
1.3.15 oxygen reading: Measured oxygen level as indicated by the oxygen monitor.
1.3.16 oxygen (or other gases) % (V/W Level of oxygen (or other gas) in a mixture expressed
as volume fraction in percent.
1.3.17 partial pressure: Pressure that each gas in a gas mixture could exert if it alone occupied
the volume of the mixture at the same temperature.
1.3.18 response time: Time required for an oxygen monitor to achieve a 90 % change to a step
function (delay response to a step change in oxygen level plus rise time).
1.3.19 rise time: Time for an oxygen monitor to change from IO % to 90 % of a step function,
1.3.20 sensing area: Part of the sensor at which oxygen is detected.
1.3.21 sensor: Part of the oxygen monitor which is sensitive to the presence of oxygen.
1.3.22 shelf life: Period during which the oxygen monitor or any of its components are stored
in its original container under conditions in accordance with the accompanying
documents.
14 . General requirements and general requirements for tests
Clauses 3 and 4 of IEC 601-I:1988 apply, together with the following additions:
3.6 Add the following text:
3.6 i) short and open circuits of the sensor and associated circuitry which increase
temperature
3.6 j) An oxidant leak which is not detected, by e.g. an alarm or periodic inspection,
shall be considered a normal condition and not a single fault condition.
4.5 Add the following text:
For reference tests a temperature of (23 -r-Z) “C, relative humidity of (60 &5) %
and atmospheric pressure between 68 kPa and 108 kPa shall be used.
Add the following section:
4.12
Other test methods
Test methods other than those specified in this International Standard, but of
equal or greater accuracy may be used to verify compliance with requirements.
However, in the event of a dispute, the methods specified in this International
Standard shall be used as the reference methods.

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IS0 7767: 1997(E)
1.5 Classification
The requirements given in clause 5 of IEC 601-I:1988 apply.
1.6 Identification, marking and documents
The requirements given in clause 6 of IEC 601-I:1988 apply, together with the following
additions and modifications:
6.1 d) Replace the text in item d) by the following:
If the size of the oxygen monitor does not permit the complete marking as
specified throughout this clause, at least the following shall be marked on the
the name of the manufacturer and the serial number; and
oxygen monitor:
symbol number 14 given in table D.l of IEC 601-1:1988.
6.1 q) Add the following text:
Oxygen monitors not meeting the requirements of section 8.2 (51.8.1)
shall be marked with the words, “Not for use in breathing systems“.
Add additional items as follows:
Oxygen monitors not meeting the requirements of section 11.1 (60.1 a.)
shall be marked with the words “Not for use with inhalation anaesthetic
agents”.
affects the accuracy of the oxygen measurement, then the
If moisture
arked with symbol nu mber 14 given in table D.1 of IEC
monitor sha II be m
601-1:1988.
The alarm set-point of the oxygen level shall be marked, if the oxyger
monitor is provided with a non-adjustable oxygen level alarm.
If the oxygen monitor or parts thereof are suitable for use in an MR
environment, they shall be so marked.
6.3 Add the following text:
Oxygen level displays shall be in percent (volume fraction) or in kilpascals.
6.3 g)
6.8.2 a) Add the following to item a):
The instructions for use shall additionally include the following information:
1) A description of the purpose and intended use of the oxygen monitor.
2) A description of the principles of operation of the oxygen monitor, including
the relationship between gas concentration and its partial pressure and the
effects of humidity.
3) A detailed specification including the following:
the oxygen level measurement range and the accuracy of measurement
[see 8.2 (51.5, 51.5.1, 51.6.1 and 51.6.2)];
the stability of measurement accuracy [see 8.2 (51.7.1 and 51.7.2)];
the response time [see 11.5 (65.1)];
the oxygen level alarm range and its accuracy [see 8.2 (51.9)];

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for diverting oxygen monitors, the range of diversion flows ]see 11.3
6231;
time from switching on to obtaining specified operating performance.
4) Information about any effect on stated function due to the following:
humidity or condensation including, for example, any adverse effects if
an adaptor is provided to improve the function of the sensor in the
presence of condensation or particulate water [see 8.2 (51.6.2)];
interfering gases or vapours [see 11.1 (6O.W;
cyclic pressure [see 8.2 (51.8)1;
barometric pressure or pressure at the site of use of the oxygen monitor;
5) Over the expected lifetime specified by the manufacturer, the accuracy
requirements specified in 8.2 (51.5 through 51.8) and the response-time
requirements in 11.5 shall be met under the conditions specified in this
International Standard.
6) The expected service life of other expendable components of the oxygen
monitor (e.g. batteries).
7) Instructions for pre-use checking and calibration.
8) Operational details for oxygen monitor or parts thereof which are marked
suitable for use in an MRI environment.
17 . Power input
The requirements given in clause 7 of IEC 601-I:1988 apply.

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IS0 7767: 1997(E)
Section 2: Environmental conditions
2.1 Basic safety categories
The requirements given in clause 8 of IEC 601-I:1988 apply.
2.2 Removable protective means
Not used.
2.3 Environmental conditions
The requirements given in clause IO of IEC 601-I:1988 apply.
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IS0 7767:1997( E)
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Section 3: Protection against electric shock hazards
3.1 General
The requirements given in clause 13 of IEC 601-I:1988 apply.
3.2 Requirements related to classification
The requirements given in clause 14 of IEC 601-I:1988 apply.
3.3 Limitation of voltage and/or energy
The requirements given in clause 15 of IEC 601-I:1988 apply.
3.4 Enclosures and protective covers
The requirements given in clause 16 of IEC 601~I:1988 apply.
3.5 Separation
The requirements given in clause 17 of IEC 601-I:1988 apply.
3.6 Protective earthing, functional earthing and potential equalization
The requirements given in clause 18 of IEC 601-I:1988 apply.
3.7 Continuous leakage currents and patient auxiliary currents
The requirements given in clause 19 of IEC 601-I:1988 apply, with the following
additions.
19.1 e) Add the following text:
The patient leakage current shall be measured at the following positions:
for non-diverting oxygen monitors, at the oxygen sensor;
for diverting oxygen monitors, at the connection port of the sampling tube.
3.8 Dielectric strength
The requirements given in clause 20 of IEC 601-I:1988 apply.

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IS0 7767: 1997(E)
Section 4: Protection against mechanical hazards
4.1 Mechanical strength
The requirements given in clause 21 of IEC 601-I:1988 apply.
4.2 Moving parts
The requirements given in clause 22 of IEC 601-I:1988 apply.
4.3 Surfaces, corners and edges
The requirements given in clause 23 of IEC 601-I:1988 apply.
4.4 Stability in normal use
The requirements given in clause 24 of IEC 60%~I:1988 apply.
45 . Expelled parts
The requirements given in clause 25 of IEC 601-I:1988 apply.
46 . Vibration and noise
The requirements given in clause 26 of IEC 601-I:1988 apply with the following
addition:
Vibration and noise shall be limited to non-hazardous levels.
1)
47 . Pneumatic and hydraulic power
Under consideration.
48 . Suspended masses
The requirements given in clause 28 of IEC 601-I:1988 apply.
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IS0 7767: 1997(E)
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Secti
on 5: Protection against hazards from unwanted or excessive
radiation
5.1 X-radiation
The requirements given in clause 29 of IEC 601-I:1988 apply.
5.2 Alpha, beta, gamma, neutron radiation and other particle radiation
Under consideration.
5.3 Microwave radiation
Under consideration.
5.4 Light radiation (including lasers)
Under consideration.
5.5 Infrared radiation
Under consideration.
5.6 Ultraviolet radiation
Under consideration.
5.7 Acoustical energy (including ultrasonics]
Under consideration.
5.8 Electromagnetic compatibility
The requirements given in clause 36 of IEC 601-I:1988 apply, with the following
addition:
The requirements given in IEC 601-I-2 apply.
36.1

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IS0 7767: 1997(E)
Section 6: Protection against hazards of ignition and flammable
anaesthetic mixtures
6.1 Locations and basic requirements
The requirements given in clause 37 of IEC 601-I:1988 apply, with the following
additions:
Anaesthetic agents which are ignited by the test in annex P of this International
Standard are classified as flammable anaesthetic agents.
Oxygen monitors specified for use with flammable anaesthetic agents shall be
shal I comply with the
classified and marked as CATEGORY APG EQUIPMENT and
requirements of APG EQUIPMENT in IEC 601-1:1988.
aesthetic agents and
NOTE: For example diethyl ether and cyclopropane are such flammable ar
halothane is a nonflammable anaesthetic agent.
6.2 Marking, accompanying documents
The requirements given in clause 38 of IEC 601-I:1988 apply.
6.3 Common requirements for category AP and category APG equipment
The requirements given in clause 39 of IEC 601-I:1988 apply.
6.4 Requirements and tests for category AP equipment, parts and components
thereof
The requirements given in clause 40 of IEC 601-I:1988 apply.
6.5 Requirements and tests for category APG equipment, parts and components
thereof
The requirements given in clause 41 of IEC 601-I:1988 apply.
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0 IS0 IS0 7767: 1997(E)
Protection against excessive temperatures and other
Section 7:
safety hazards
71 .
Excessive temperatures
The requirements given in clause 42 of IEC 601-I:1988 apply.
7.2 Fire prevention
The requirements given in clause 43 of IEC 601-I:1988 apply, with the following
addition:
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 normal and single fault conditions. Compliance is
checked by determining the temperature to which the material is raised under normal
and single fault condition.
If sparking can occur under normal or single fault conditions, 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
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-I:1988 apply.
7.4 Pressure vessels and parts subject to pressure
Not applicable.
7.5 Human errors
Not used.
7.6 Electrostatic charges
Not used.
7.7 Materials in applied parts in contact with body of patient
Not used.
7.8 Interruption of power supply
The requirements given in clause 49 of IEC 601-I:1988 apply.
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IS0 7767: 1997(E)
Accuracy of operating data and protection against
Section 8:
hazardous output
8.1 Accuracy of operating data
The requirements given in clause 50 of IEC 601-I:1988 apply.
82 . Protection against hazardous output
The requirements given in clause 51 of IEC 601-I:1988 apply, with the following
additions:
51.5 Measurement accuracy
The difference between the mean oxygen reading and the oxygen level shall be within
k3 % (V/v) over the range specified in table 1. Compliance shall be checked by the test
given in 51.5.3.
51.5.1 Display range
The oxygen reading displayed on a digital display shall not be limited to 100 %. If
digital displays are used, there shall be an indication when the overrange value exceeds
99 (two-digit display) or 100 (three-digit display), plus the monitor error. Compliance
shall be checked by the test given in 51.5.2.
51.5.2 Display range test method
Compliance shall be checked by simulating the appropriate out-of-range condition.
51.5.3 Oxygen level test method
Oxygen readings are taken at a number of oxygen levels spanning the oxygen monitor
measurement range.
Test gases of a composition accuracy equal to or better than l/5 of the tolerance of the
requirements stated in 51.5 as determined by gravimetric methods shall be used for
these tests. Alternative methods of certifying gas composition accuracy may be
substituted for the gravimetric method if the alternative method can be shown to be
equivalent to or better than the gravimetric method.
51.5.3.1 Dry gas
The oxygen monitor shall be set up in accordance with the accompanying documents
and tested using the dry test gas mixtures given in table 1, under the conditions stated
in 1.4.
- Dry gas mixtures
Table 1
Oxygen % (V/V)
(Balance nitrogen)
15
21
40
60
100
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51.5.3.2 Water-saturated gas
This requirement does not apply to oxygen monitors intended solely for use in dry gas
mixtures.
The oxygen monitor shall be set up in accordance with the accompanying documents.
Operate the monitor in accordance with the manufacturer’s instructions for a minimum
of 1 h using gas saturated at (37 93) “C.
At the end of this period, perform an accuracy test using the gas mixtures given in table
2 (with a dry gas accuracy specified in 51.5.3) saturated at (37 ~3) “C.
Table 2 - Water-saturated gas test mixtures
Oxygen % (V/V)
(Balance nitrogen)
15
21
40
60
100
Oxygen monitors shall maintain the accuracy required in 51.5 after readings are
corrected for volumetric changes caused by humidity as specified in the accompanying
documents.
51.6 Drift of measurement accuracy
The oxygen monitor shall meet the requirements specified in 51.5 for a minimum of 8 h
when used in accordance with the accompanying documents.
Compliance shall be checked by the test given in 51.6.1
51.6.1 Water-saturated gas
This requ irement does not apply to oxygen monitors intended solely for use in dry gas
mixtures.
oxygen mon itor as specified in 51.5.3.2, sampling for gas test
Continue to operate the
2 h for a min imum of 8 h.
mixtures in table 2 every
51.6.2 Dry gas
If the oxygen monitor is tested by the method in 51.6.1, this subclause does not apply.
The oxygen monitor shall be set up in accordance with the accompanying documents
and using ambient conditions described in 51.5.3.1. Connect the oxygen monitor to a
supply of dry air at (23 2 2) “C.
Operate the monitor for a minimum of I h.
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IS0 7767: 1997(E) @ IS0
At this time, perform an accuracy test using the dry gas method as described in 51.5.3.1
and using the test gas mixtures given in table 1.
Continue to operate for a minimum of 8 h, repeating the accuracy test every 2 h.
51.7 Pressure effects
51.7.1 General
Oxygen monitors shall either:
a) meet the requirements given in 51.5 following exposure of the sampling site to a
nominal positive pressure of IO kPa (100 cmH,O) and a nominal negative pressure of
I,5 kPa (15 cmH,O) for 5 s each for 20 cycles:
b) be marked with a warning “NOT FOR USE IN BREATHING SYSTEMS” and a similar
warning shall appear in the accompanying documents (see Section 6).
Compliance shall be checked by the test given in 51.7.2.
51.7.2 Test for pressure effects
51.7.2.1 Principle
The accuracy of the oxygen monitor is determined after exposure of the sensor to
pressure cycling.
51.7.2.2 Procedure
Cycle the pressure at the sampling site between a positive pressure with respect to
ambient of (IO -c 1) kPa [(IO0 k IO) cmH,Ol and a negative pressure with respect to
ambient of (1,5+ 0,2) kPa [(I5 -c 2) cmH,Ol for not less than 5 s each. Repeat this
procedure 20 times, then carry out the test for measurement accuracy using the dry gas
method as described in 51.5.3.1 using the gases listed in table 1.
51.8 Alarms
51.8.1 Alarm annunciation shall comply with the requirements of IS0 9703-I and IS0
9703-Z.
51.8.2 The set points of adjustable alarms shall be indicated continuously or on
operator demand.
51.8.3 If a means of temporarily silencing the auditory alarm(s) is provided, this
silencing shall not exceed 120 s.
51.8.4 If provided, a remote alarm extension shall be arranged so that a failure in the
remote circuit will not affect the correct functioning of the local alarm.
The oxygen monitor shall have a low-oxygen alarm set point. The low-oxygen
51.8.5
alarm set point shall not have a default setting lower than 18 %. If, by special provision,
the low-oxygen alarm set point can be set below 18 % (V/v), there shall be a separate
continuous visual indication when the monitor is so set.
51.8.6 The low- and high-oxygen alarms shall activate for:
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IS0 7767:1997( E)
ow-0 xygen alarm: oxygen readings less than or equal to the low-oxygen alarm set
a) I
poi nt.
b) high-oxygen alarm (if provided): oxygen readings greater than or equal to the high-
oxygen alarm set point.
A low-oxygen alarm shall cause at least a medium-priority annunciation. A high-
oxygen alarm (if provided) shall cause at least a medium-priority annunciation.
51.8.7 If alarm parameters are adjustable by the operator, means shall be provided to
prevent unintentional change of such adjustable settings.
NOTE: Prevention of unintentional change may be achieved by a deliberate sequence of operator
actions, a recess or guard over the control
51.8.8 Compliance shall be checked by inspection and by simulation of the alarm
conditions in accordance with the accompanying documents.
51.9 Function and position of controls
Check or test controls which validate battery condition or signal operation and
signal override shall automatically return from the check or test position.
all include means to prevent an inadvertent change from
Cali bration controls sh
the intended position.
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IS0 7767:1997(E)
Section 9 - Abnormal operation and fault conditions;
environmental tests
9.1 Abnormal operation and fault conditions
The requirements given in clause 52 of IEC 601-I:1988 apply.
9.2 Environmental tests
The requirements given in clause 53 of IEC 601-I:1988 apply.
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IS0 7767: 1997(E)
Section 10 - Constructional requirements
10.1 General
The requirements given in clause 54 of IEC 601-I:1988 apply.
10.2 Enclosures and covers
Not used.
10.3 Components and general assembly
The requirements given in clause 56 of IEC 601-I:1988 apply.
Mains parts, components and layout
10.4
The requirements given in clause 57 of IEC 601-I:1988 apply.
10.5 Protective earthing - Terminals and connections
ause 58 of IEC 601-I:1988 apply.
The requirements given in cl<
10.6 Construction and layout
The requirements given in cl1 ause 59 of IEC 601-I:1988 apply.
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IS0 7767:1997( E)
Section II - Additional requirements
11.1 Interfering gas and vapour effects
11.1.1 Interference with measurement accuracy
Oxygen monitors shall either:
a) have not more than 2 % (V/v) oxygen interference with measurement accuracy in the
presence of any of the gases or vapours at the levels listed in table 3, or
b) if the body of the oxygen monitor is marked “‘Not for use with inhalation agents” or
equivalent, the oxygen monitor shall not have more than 2 % (V,, oxygen interference
with measurement accuracy in the presence of helium or carbon dioxide at the levels
listed in table 3. If the oxygen interference is greater than 1 % (V/v) this shall be stated
in the accompanying documents.
Compliance shall be checked by the test given in 11.1.2.
Table 3 - inhalation anaesthetics and other interfering gases and vapours
Gas or vapour Ilevel
(Balance: mixture of 30 % OJ70 % N,O, except where noted)
Helium 50 %, balance 0,
5/ 0
Carbon dioxide
Nitrous oxide (N,O) 800%, balance 0,
Halothane 4/ 0 0
Enflurane 5/ 0 0
Isoflurane 5/ 0 0
5/ 0
Sevoflurane
Desflurane 15;
Nitric oxide (NO) 50 ppm in a balance of
30 % 0, /70 % N, (see NOTE)
Diethyl ether 20 % (APG only)
NOTE: The NO and 0, components of the mixture must be introduced in such a manner as to
minimize the formation of NO, at the measuring point.
11 .I 2 Compliance tests
11.1.2.1 Principle
Determination of the accuracy of the oxygen reading in the presence of interfering gases and
vapours given in table 3.
11 .I 2.2 Test gases
Use dry premixtures of 30% oxygen and 70% nitrous oxide and the interfering gas or vapour at
the level given in table 3, the oxygen
...

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