ISO 8835-2:1999
(Main)Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems for adults
Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems for adults
Systèmes d'anesthésie par inhalation — Partie 2: Systèmes respiratoires d'anesthésie pour adultes
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8835-2
Second edition
1999-05-01
Inhalational anaesthesia systems —
Part 2:
Anaesthetic breathing systems for adults
Systèmes d'anesthésie par inhalation —
Partie 2: Systèmes respiratoires d'anesthésie pour adultes
A
Reference number
ISO 8835-2:1999(E)
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ISO 8835-2:1999(E)
Contents
1 Scope .1
2 Normative references .1
3 Definitions .1
4 Breathing-system connections and materials.3
5 Breathing systems either supplied assembled or assembled in accordance with the manufacturer’s
instructions .4
6 Exhaust valves.4
7 Circle absorber assemblies .5
8 Pressure monitoring and limitation .7
9 Location of components in circle absorber breathing systems .7
10 Marking .8
11 Information to be provided by the manufacturer .10
Annex A (normative) Type test methods .13
Annex B (informative) Breathing-system notation.17
Annex C (informative) Rationale .21
Bibliography.22
© ISO 1999
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.
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Internet iso@iso.ch
Printed in Switzerland
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ISO 8835-2:1999(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
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 8835-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This second edition cancels and replaces the first edition (ISO 8835-2:1993), which has been technically revised.
The major difference between this revision and the first edition is the broadening of the scope to include all types of
breathing system.
ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
Part 1: Published as IEC 60601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for the
safety of anaesthetic workstations
Part 2: Anaesthetic breathing systems for adults
Part 3: Anaesthetic gas scavenging systems — Transfer and receiving systems
Annex A forms an integral part of this part of ISO 8835. Annexes B and C are for information only.
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Introduction
A breathing system comprises an assembly of tubes and connectors and may include valves, a reservoir bag and a
circle absorber assembly. Its function is to convey mixtures of gases to and from the patient.
Other items of equipment may be incorporated into a breathing system, e.g. humidifiers, filters, spirometers,
thermometers and gas analysers.
Annex A (normative) gives test methods. Annex B (informative) describes a standardized set of graphical symbols
for breathing attachments and gives some examples of their use in a schematic representation of a circle absorber
system, and annex C (informative) gives the rationale for some of the requirements.
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INTERNATIONAL STANDARD © ISO ISO 8835-2:1999(E)
Inhalational anaesthesia systems —
Part 2:
Anaesthetic breathing systems for adults
1 Scope
This part of ISO 8835 specifies requirements for inhalational anaesthetic breathing systems for adults which are
supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer’s
instructions. It also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in
some designs, those parts of an anaesthetic breathing system that are incorporated within an anaesthetic
workstation, including the expiratory gas pathway of an anaesthetic ventilator and any parts of a non-operator-
detachable anaesthetic-gas scavenging system (AGSS).
This part of ISO 8835 does not cover the performance of breathing systems regarding the elimination of expired
carbon dioxide, since this is complex and depends on the interaction of the patient, the fresh-gas flow, the carbon
dioxide absorbent and the breathing system itself.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 8835. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 8835 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 4135:1995, Anaesthesiology — Vocabulary.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors.
ISO 5362, Anaesthetic gas reservoir bags.
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators.
ISO 7000:1989, Graphical symbols for use on equipment — Index and synopsis.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
3 Definitions
For the purposes of this part of ISO 8835 the definitions in ISO 4135:1995, together with the following, apply. Terms
3.1, 3.2 and 3.9 are also defined in ISO 4135:1995 but the definitions in this part of ISO 8835 relate more
particularly to anaesthetic breathing systems than do those in ISO 4135:1995.
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3.1
breathing system
those inspiratory and expiratory pathways through which gas flows at respiratory pressure between the fresh-gas
inlet, the patient-connection port and the exhaust valve or port
3.2
circle breathing system
breathing system in which the direction of gas flow through inspiratory and expiratory pathways is unidirectional and
in which the two pathways form a circle
3.3
circle absorber assembly
that part of a circle system which comprises one or more carbon-dioxide-absorbent containers, inspiratory and
expiratory valves or other means of ensuring unidirectional gas flow, two ports for connection to breathing tubes, a
fresh-gas inlet, a reservoir bag port and/or a ventilator port
3.4
fresh-gas inlet
that port through which fresh gas is supplied to the breathing system
3.5
fresh-gas tube
tube conveying fresh gas to the fresh-gas inlet
3.6
patient-connection port
that port at the patient end of a breathing system intended for connection to devices such as a tracheal or
tracheostomy tube connector, or to a face mask
3.7
exhaust port
that port through which excess and/or waste gas(es) are discharged to the atmosphere or to an anaesthetic-gas
scavenging system (AGSS)
3.8
exhaust valve
a valve through which excess and/or waste gas(es) are discharged to the atmosphere or to an AGSS
NOTE Such a valve may or may not be an adjustable pressure-limiting (APL) valve
3.9
Y-piece
3-way breathing-system connector
3-way connector with a patient-connection port and two ports for connection to breathing tubes
3.10
non-rebreathing exhaust valve
exhaust valve with three ports, namely an inlet port for connection to a breathing tube or attachment, a patient-
connection port and an exhaust port, the function of the valve being to prevent exhaled gas from entering the
breathing system
NOTE Such a valve may or may not allow intermittent positive-pressure ventilation.
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4 Breathing-system connections and materials
4.1 Connectors
4.1.1 Patient-connection port
The patient-connection port shall have a male 22 mm conical connector incorporating a coaxial female 15 mm
conical connector, both complying with ISO 5356-1.
4.1.2 Y-piece
The machine ends of a Y-piece not permanently attached to breathing tubes shall be either 22 mm male conical
connectors complying with ISO 5356-1 or other connectors which mate with breathing tubes complying with
ISO 5367.
NOTE The Y-piece may be so designed that the patient-connection port swivels.
4.1.3 Exhaust port
Exhaust port(s) on a breathing attachment shall be one of the following:
a) 30 mm male conical connector(s) complying with ISO 5356-1 and with means to prevent connection of the
orifice to any breathing attachment;
b) proprietary fitting(s) incompatible with connectors complying with ISO 5356-1 and breathing tubes complying
with ISO 5367;
c) non-operator-detachable connection(s) to the transfer hose(s) of a non-interchangeable AGSS.
NOTE See 10.1.and 10.2 for marking requirements.
4.1.4 Connection port for reservoir bags
The connection port for a reservoir bag shall be a connector that mates with breathing tubes or reservoir bags
complying with ISO 5367 or ISO 5362 respectively.
NOTE See10.1 and 10.2 for marking requirements.
4.1.5 Ventilator port
If an operator-accessible ventilator port is provided, it shall be a 22 mm male conical connector complying with
ISO 5356-1.
NOTE See 10.1 and 10.2 for marking requirements.
4.1.6 Ports on operator-interchangeable breathing attachments
Interchangeable breathing attachments intended for use within a breathing system shall have conical connectors of
either 15 mm or 22 mm size complying with ISO 5356-1 or ISO 5356-2.
4.1.7 Other ports
Ports used for purposes such as sampling, monitoring and pressure measurement shall not have connectors
complying with ISO 5356-1 or ISO 5356-2 and shall be provided with a means to secure engagement and closure of
the ports when not in use.
4.2 Bag/ventilator selector switch
If a switch is provided to change from bag to ventilator and vice versa, it shall be bi-stable.
NOTE See 10.1 and 10.2 for marking requirements.
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4.3 Electrical conductivity
Breathing systems and breathing attachments marked as "antistatic" shall comply with the requirements for
prevention of electrostatic charges specified in 39.3 b) of IEC 60601-1:1988.
4.4 Recommendations on materials
When selecting materials for components of breathing systems, manufacturers should take particular care to ensure
compatibility of the materials with the gases and anaesthetic agents with which they are intended to come into
contact.
5 Breathing systems either supplied assembled or assembled in accordance with the
manufacturer’s instructions
5.1 Leakage
The leakage to atmosphere from a complete breathing system when tested as described in clause A.2 in all the
operational modes stated by the manufacturer [see 11 b) 2)] should preferably not exceed 50 ml/min but shall not
exceed 150 ml/min (15,21 kPa×l/min). The manufacturer shall disclose the leakage rate if it is between 51 ml/min
and 150 ml/min.
5.2 Resistance to flow
When tested as described in clause A.3, the pressure generated at the patient-connection port shall not exceed
– 0,6 kPa (– 6 cmH O).
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5.3 Cleaning and disinfection or sterilization
Unless the breathing system is intended and marked as being for single use, the manufacturer shall recommend
methods of cleaning and disinfection or sterilization [see 11 g)].
6 Exhaust valves
6.1 Direction of movement of controls
For operator-adjustable exhaust valves with rotary controls, movement of the control in a clockwise direction shall
progressively increase the limiting pressure.
NOTE In some designs, movement of the control to a fully clockwise position does not close the valve.
6.2 Resistance to flow
6.2.1 Opening pressure
The manufacturer shall disclose the minimum opening pressure of the valve [see 11 c) 2) and 11 c) 3)].
6.2.2 Pressure-flow characteristics
For exhaust valves supplied separately, the manufacturer shall disclose the pressure-flow characteristics of the
valve, including the pressure drop with any valve control fully open at a flow of 30 l/min [see 11 c) 2) and 11 c) 3)].
6.3 Leakage
For an exhaust valve supplied separately that can be fully closed, the manufacturer shall disclose the leakage to
atmosphere in the closed position at a pressure of 3 kPa (30 cmH O) [see 11 c) 6)].
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6.4 Non-rebreathing exhaust valves supplied separately
6.4.1 Ports
The inlet port shall have a male 22 mm conical connector complying with ISO 5356-1 and shall not be a
22 mm/15 mm co-axial connector [see also 10.2.2 h)].
The patient-connection port shall comply with 4.1.1.
The exhaust port shall comply with 4.1.3.
6.4.2 Resistance to flow
6.4.2.1 Opening pressure
The manufacturer shall disclose the minimum opening pressure of the valve [see 11 c) 2) and 11 c) 3)].
6.4.2.2 Pressure-flow characteristics
The manufacturer shall disclose the pressure-flow characteristics of the valve, including the pressure drop with any
valve control fully open at a flow of 30 l/min [see 11 c) 2) and 11 c) 3)].
7 Circle absorber assemblies
7.1 Construction
7.1.1 The design of the carbon-dioxide-absorbent container shall enable the colour change of the absorbent to be
clearly visible.
7.1.2 Circle absorber assemblies supplied separately shall incorporate inspiratory and expiratory valves or other
means of ensuring unidirectional gas flow. If these valves or means can be detached from the absorber unit, the
method of attachment to the latter shall be by means of connectors which are non-interchangeable with each other
and which are not compatible with any of the connectors specified in ISO 5356-1 and ISO 5356-2.
7.2 Absorbent-bypass mechanism
7.2.1 If a means of excluding the absorbent from the gas pathway is provided, the operation of which is actuated
automatically by removing the absorbent container(s), the circle absorber assembly shall meet the leakage
requirements of 7.3.1 and the resistance to flow requirement of 7.4 with the container(s) in place and removed.
When the mechanism for excluding the absorbent is operator-controlled, the control shall have means to
7.2.2
prevent accidental movement and shall be durably marked with the clearly legible words “on” and “off” or the
equivalent in the national language, and/or with the symbols shown in figure 1. The “off” indication shall mean that
gas does not pass through the absorbent and the indication shall be visible to the operator from his/her normal
operating position.
NOTE The words “on” and “off” may be preceded by the word “absorber”.
7.2.3 Unless the absorbent-bypass mechanism is intended to function at one or more intermediate setting(s), the
control shall have only “on” and “off” positions and shall be bi-stable. The circle absorber assembly shall meet the
leakage requirements of 7.3 and the resistance to flow requirements of 7.4 with the control in the “on” and “off”
positions.
7.2.4 For a bypass mechanism intended to function at one or more intermediate setting(s), the control shall so
indicate and the circle absorber assembly shall meet the leakage requirements of 7.3 and the resistance to flow
requirements of 7.4 in the “on” and “off” positions and at any intermediate setting of the control.
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a) Symbol for "absorber on" b) Symbol for "absorber off"
Figure 1 — Markings for operator-controlled absorbent-bypass mechanism
7.3 Leakage
7.3.1 For a circle absorber assembly with an operator-controlled absorbent-bypass mechanism, when the control
is in the “off” position it shall be possible to change the absorbent without opening the gas pathway to the
atmosphere.
7.3.2 For an assembly supplied separately, the manufacturer shall disclose the leakage to atmosphere when
tested as described in clause A.4.
7.4 Resistance to flow
For a circle absorber assembly supplied separately, the pressure generated at the patient-connection port shall not
exceed – 0,6 kPa (– 6 cmH O) when tested as described in clause A.4.
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7.5 Inspiratory and expiratory ports
Inspiratory and expiratory ports shall be either 22 mm male conical connectors or coaxial 22/15 mm conical
connectors complying with ISO 5356-1 or ISO 5356-2. The inspiratory and expiratory ports shall be differentiated
from the reservoir bag port.
NOTE 1 See 10.1 and 10.2 for marking requirements.
NOTE 2 Differentiation of the ports can be achieved by, e.g., different orientation.
7.6 Inspiratory and expiratory valves
7.6.1 General
Unless a means of indicating valve malfunction is provided, the valves shall be designed and located such that their
action is visible to the operator.
7.6.2 Reverse flow and dislocation
When tested as described in clause A.6, the pressure shall rise to at least 0,5 kPa (5 cmH O) within 5 min and the
2
valve disc or flap shall not become dislocated on application of a reverse pressure of 5 kPa (50 cmH O).
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NOTE 1 Requiring the pressure to rise to at least 0,5 kPa within 5 min is equivalent to requiring that the reverse flow does
not exceed 60 ml/min at a pressure of up to 0,5 kPa (see also the note to A.6.2.1).
NOTE 2 Typically, the most significant reverse flow with disc-type valves is at pressures of less than 0,05 kPa (0,5 cmH O),
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whereas with flap valves it can be at a higher pressure.
7.6.3 Resistance to flow
For inspiratory and expiratory valves supplied as separate components, the manufacturer shall disclose the
pressure-flow characteristics of the valves under both wet and dry conditions, including the pressure drop at a flow
of 60 l/min [see 11 e) 1) and 11 e) 2)].
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7.6.4 Opening pressure
For inspiratory and expiratory valves supplied as separate components, the manufacturer shall disclose the
pressure required to open the valves under both wet and dry conditions [see 11 e) 1) and 11 e) 2)].
8 Pressure monitoring and limitation
8.1 Pressure monitoring
8.1.1 The anaesthetic breathing system shall incorporate either a pressure-measuring device or a means for
connection to a pressure-measuring device.
8.1.2 If a pressure-measuring device is provided, it shall be marked in units of cmH O and/or kPa and shall have a
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minimum range from either –10 cmH O to +60 cmH O or from –1 kPa to +6 kPa, as appropriate.
2 2
Under conditions of dynamic testing, readings shall be within a tolerance of – (4 % of the full scale reading + 4 % of
the reading).
8.1.3 To permit cleaning and disinfection or sterilization of the components of the breathing system , the pressure-
measuring device shall either be detachable or itself capable of being cleaned and disinfected or sterilized.
8.2 Pressure limitation
If a pressure-limiting device is provided, then both during normal conditions and under a single-fault condition the
pressure at the patient-connection port shall not exceed 12,5 kPa (125 cmH O).
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9 Location of components in circle absorber breathing systems
9.1 Exhaust valve
An exhaust valve shall not be located between the inspiratory valve and the Y-piece.
9.2 Port for connection to a reservoir bag
On a circle absorber assembly, the port for connection to a reservoir bag shall not be on the patient side of the
inspiratory or expiratory valve(s).
9.3 Fresh-gas inlet
If a fresh-gas inlet is permanently located on an absorber assembly, it shall not be on the patient side of the
expiratory valve.
The fresh-gas inlet should preferably be between the carbon-dioxide-absorbent container and the inspiratory valve.
9.4 Inspiratory valves and expiratory valves
Inspiratory valves and expiratory valves shall not be located in the Y-piece.
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10 Marking
10.1 Marking of breathing systems supplied complete
10.1.1 Marking of breathing systems intended for single use
Breathing systems supplied complete and intended for single use shall be legibly marked with the following:
NOTE See also 7.2.2, 7.2.4 and 7.5.
a) The name and/or trademark of the manufacturer and/or supplier.
b) An identification reference to the lot or date of manufacture.
c) The maximum limiting pressure, if the system has a designed limiting pressure.
d) For exhaust ports complying with 4.1.3, the word “EXHAUST” and/or “AGS” or the equivalent in the national
language or an appropriate symbol.
e) For ventilator ports complying with 4.1.5, the word “VENTILATOR” or the equivalent in the national language or
an appropriate symbol.
f) The word “ANTISTATIC” for breathing systems and integrally attached non-metallic components made of
antistatic materials.
NOTE They may also bear an indelible yellow-coloured mark.
g) If a switch is provided to change from bag to ventilator and vice versa, it shall be marked with the words “BAG”
and “VENTILATOR” or the equivalent in the national language and/or appropriate symbols.
10.1.2 Marking of breathing systems intended for re-use
Complete breathing systems intended for re-use shall be durably and legibly marked with the following:
NOTE See also 7.2.2, 7.2.4 and 7.5.
a) The name and/or trademark of the manufacturer and/or supplier.
b) An identification reference to the lot or date of manufacture.
c) The maximum limiting pressure, if the system has a designed limiting pressure.
d) For exhaust ports complying with 4.1.3, the word “EXHAUST” and/or “AGS” or the equivalent in the national
language or an appropriate symbol.
e) For reservoir bag ports complying with 4.1.4, the word “BAG” or the equivalent in the national language and/or
an appropriate symbol.
f) For ventilator ports complying with 4.1.5, the word “VENTILATOR” or the equivalent in the national language or
an appropriate symbol.
g) The word “ANTISTATIC” for breathing systems and integrally attached non-metallic components made of
antistatic materials.
NOTE They may also bear an indelible yellow-coloured mark.
h) If a switch is provided to change from bag to ventilator and vice versa, it shall be marked with the words “BAG”
and “VENTILATOR” or the equivalent in the national language and/or appropriate symbols.
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10.2 Marking of breathing attachments
10.2.1 Marking of breathing attachments intended for single use
Operator-detachable breathing attachments (e.g. exhaust valves, inspiratory and expiratory valves) intended for
single use shall be legibly marked with the following:
NOTE See also 7.2.2, 7.2.4, 7.5 and clause 8.
a) The name and/or trademark of the manufacturer and/or supplier.
b) An identification reference to the lot or date of manufacture.
c) The maximum limiting pressure, if the component has a designed limiting pressure.
d) For exhaust ports complying with 4.1.3, the word “EXHAUST” and/or “AGS” or the equivalent in the national
language or an appropriate symbol.
e) For connection ports for reservoir bags complying with 4.1.4, the word “BAG” or the equivalent in the national
language or an appropriate symbol.
f) For ventilator ports complying with 4.1.5, the word “VENTILATOR” or the equivalent in the national language or
an appropriate symbol.
g) The word “ANTISTATIC” for breathing attachments and integrally attached non-metallic components made of
antistatic materials.
NOTE They may also bear an indelible yellow-coloured mark.
h) Flow-direction-sensitive components shall be marked with at least one arrow to indicate the direction of gas
flow.
NOTE 1 The words “INLET” and “OUTLET” or the equivalent in the national language may be marked in addition.
NOTE 2 The safe and correct functioning of certain breathing attachments is dependent upon the direction of gas flow
through them.
i) If a switch is provided to change from bag to ventilator and vice versa, it shall be marked with the words “BAG”
and “VENTILATOR” or the equivalent in the national language and/or appropriate symbols.
10.2.2 Marking of breathing attachments intended for re-use
Operator-detachable breathing attachments (e.g. exhaust valves, inspiratory and expiratory valves) intended for re-
use shall be durably and legibly marked with the following:
NOTE See also 7.2.2, 7.2.4, 7.5 and clause 8.
a) The name and/or trademark of the manufacturer and/or supplier.
b) An identification reference to the lot or date of manufacture.
c) The maximum limiting pressure, if the component has a designed limiting pressure.
d) For exhaust ports complying with 4.1.3, the word “EXHAUST” and/or “AGS” or the equivalent in the national
language or an appropriate symbol.
e) For reservoir bag ports complying with 4.1.4, the word “BAG” or the equivalent in the national language and/or
an appropriate symbol.
f) For ventilator ports complying with 4.1.5, the word “VENTILATOR” or the equivalent in the national language
and/or an appropriate symbol.
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g) The word “ANTISTATIC” for breathing attachments and integrally attached non-metallic components made of
antistatic materials.
NOTE They may also bear an indelible yellow-coloured mark.
h) Flow-direction-sensitive components shall be marked with at least one arrow to indicate the direction of gas
flow.
NOTE 1 The words “INLET” and “OUTLET” or the equivalent in the national language may be marked in addition.
NOTE 2 The safe and correct functioning of certain breathing attachments is dependent upon the direction of gas
flow through them.
i) If a switch is provided to change from bag to ventilator and vice versa, it shall be marked with the words “BAG”
and “VENTILATOR” or the equivalent in the national language and/or appropriate symbols.
10.3 Marking of packages
10.3.1 Packages containing breathing attachments or complete breathing systems intended for single use shall be
legibly marked with the following:
a) A description of the contents.
b) The words “FOR SINGLE USE” or symbol No. 1051 (indicating “do not re-use”) given in ISO 7000:1989.
c) If appropriate, the word “STERILE” or a symbol.
d) The name and/or trademark of the manufacturer and/or supplier.
e) An identification reference to the lot or date of manufacture.
10.3.2 Packages containing breathing attachments or complete breathing systems intended for re-use shall be
legibly marked with the following:
a) A description of the contents.
b) The name and/or trademark of the manufacturer and/or supplier.
c) Recommended methods of cleaning and sterilization or disinfection, including the maximum number of cycles
recommended.
d) An identification reference to the lot or date of manufacture.
10.3.3 Packages containing breathing attachments or complete breathing systems made of antistatic material shall
be legibly marked with the word “ANTISTATIC” or the equivalent in the national language.
11 Information to be provided by the manufacturer
The following information shall be provided by the manufacturer for complete breathing systems and for breathing
attachments supplied separately:
a) for all breathing systems and breathing attachments
A stat
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