SIST EN ISO 11196:2000

Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)

NOTE1: 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 601-1:1998 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 level(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 anaesthetic 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.

Überwachungsgeräte für Anästhesiegase (ISO 11196:1995 einschließlich Technisches Korrigendum 1:1997)

ANMERKUNG 1: Siehe Begründung in Anhang N. ISO 11196 ist Teil einer Internationaler Normenreihe, die auf IEC 601-1 basiert. In IEC 601-1 (der "Allgemeinen Festlegung") wird diese Art einer Internationalen Norm als "Besondere Fetslegung" bezeichnet. Wie in 1.3 von IEC 601-1:1988 festgestellt, haben die Anforderungen dieser Internationalen Norm Vorrang vor denen der 601-1.

Dispositifs de contrôle de gaz d'anesthésie (ISO 11196:1995 Rectificatif Technique 1:1997 inclus)

Monitorji za spremljanje anestezijskih plinov in hlapov (ISO 11196:1995, vključno s tehničnim popravkom 1:1997)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 31-Aug-2005
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Sep-2005
• Due Date: 01-Sep-2005
• Completion Date: 01-Sep-2005
• 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 11196:1997 - Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)

Relations

• Replaced By: SIST EN ISO 21647:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 01-Sep-2005

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11196:2000
01-januar-2000
0RQLWRUML]DVSUHPOMDQMHDQHVWH]LMVNLKSOLQRYLQKODSRY,62YNOMXþQRV
WHKQLþQLPSRSUDYNRP
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
SIST EN ISO 11196:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11196:2000

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SIST EN ISO 11196:2000

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SIST EN ISO 11196:2000

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SIST EN ISO 11196:2000
INTERNATIONAL
ISO
STANDARD
11196
First edition
1995-1 O-l 5
Anaesthetic gas monitors
Dispositifs de con tr6le de gaz d ‘anesthksie
Reference numbea
ISO 11196:1995(E)

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SIST EN ISO 11196:2000
ISO 11196:1995(E)
Contents
Page
General
Section 1
. . . . . . . . . . . . .
1.1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . “.~. “.
1.2 Normative references . . . .
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Definitions
. . . 4
1.4 General requirements and general requirements for tests
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Classification
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Identification, marking and documents
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
11
.,.
Section 3 Protection against electric shock hazards
........................... 11
3.1 General .
...... ........................... 11
Requirements related to classification
3.2
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Limitation of voltage and/or energy
. .*. .*. 11
3.4 Enclosures and protective covers
11
3.5 Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Protective earthing, functional earthing and potential
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
equalization
. . 11
3.7 Continuous leakage current and Patient auxiliary currents
............................. ............................. 11
3.8 Dielectric strength .
12
. . . . . . . . . . . . . . . . . .
Section 4 Protection against mechanical hazards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.1 Mechanical strength
12
........ ................................................................
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

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SIST EN ISO 11196:2000
0 ISO
ISO 11196:1995(E
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3 Surface, corners and edges
12
4.4 Stability in normal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Expelled Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6 Vibration and noise
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.7 Pneumatic and hydraulic power
12
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
13
radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3 Microwave radiation
13
5.4 Light radiation (including lasers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.5 Infrared radiation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.6 Ultraviolet radiation
. . . . . . . . . . . . . . . . . . . . . . . . . .p. 13
5.7 Acoustical energy (including ultrasonics)
13
5.8 Electromagnetit compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section 6 Protection against hazards of ignition of flammable
14
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

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SIST EN ISO 11196:2000
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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)
23
11.2 Obstruction of sampling tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
11.3 Breathing System connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24
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

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SIST EN ISO 11196:2000
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.

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SIST EN ISO 11196:2000
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.

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SIST EN ISO 11196:2000
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.

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SIST EN ISO 11196:2000
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.
2

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SIST EN ISO 11196:2000
ISO 11196:1995(a
80
c
a
c
70
s
60
f
U
a
aJ
t
Ul 50
0
t
40
30
t
c
s 20
c
t
t
-
IO
0
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).

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SIST EN ISO 11196:2000
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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?

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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.
5

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SIST EN ISO 11196:2000
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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.

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SIST EN ISO 11196:2000
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The requirements given in clause 6.5 of IEC 601-1 :1988 apply.
6.6 Ide
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