ISO/TS 18835:2004

Inhalational anaesthesia systems — Draw-over vaporizers and associated equipment

ISO/TS 18835:2004 specifies safety and performance requirements for draw-over vaporizers and associated equipment to provide draw-over anaesthetic systems for patients weighing greater than 15 kg using both non-flammable and, in places where regulations permit their use, flammable anaesthetic agents. No requirements for monitoring the equipment are given in ISO/TS 18835:2004.

Systèmes d'anesthésie par inhalation — Alimentation en vapeur et équipements annexes

General Information

• Status: Withdrawn
• Publication Date: 01-Jul-2004
• Withdrawal Date: 01-Jul-2004
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Drafting Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 02-Apr-2015

Relations

• Revised: ISO 18835:2015 - Inhalational anaesthesia systems — Draw-over anaesthetic systems
• Effective Date: 10-May-2012

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 18835
First edition
2004-07-01

Inhalational anaesthesia systems —
Draw-over vaporizers and associated
equipment
Systèmes d'anesthésie par inhalation — Alimentation en vapeur et
équipements annexes




Reference number
ISO/TS 18835:2004(E)
©
ISO 2004

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ISO/TS 18835:2004(E)
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ISO/TS 18835:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 ∗∗
∗∗
 Air/oxygen reservoir . 2
4.1 Connections . 2
4.2 Draw-over vaporizer. 2
4.3 Inflating bellows device. 3
4.4 Anaesthetic patient valve. 3
4.5 Connecting tubes. 3
5 Construction. 4
5.1 General. 4
5.2 Draw-over vaporizer. 4
5.3 Air/oxygen reservoir . 5
5.4 ∗∗∗∗
 Inflating bellows device . 5
5.5 Anaesthetic patient valve dismantling and reassembly . 5
6 Performance . 5
6.1 Draw-over vaporizer. 5
6.2 Air/oxygen reservoir . 6
6.3 Inflating bellows device. 6
6.4 Anaesthetic patient valve. 6
6.5 Complete system — Resistance to spontaneous inspiration and expiration . 7
7 Arrangement of components in draw-over anaesthetic system. 7
7.1 ∗∗∗∗
 Oxygen inlet . 7
7.2 ∗∗
∗∗
 Vaporizer . 7
8 Marking of components. 7
8.1 General. 7
8.2 Marking of breathing-system attachments.7
8.3 Marking of draw-over vaporizer. 7
8.4 Marking of air/oxygen reservoir . 8
8.5 Marking of inflating bellows device . 8
8.6 Marking of packages. 8
9 Information to be provided with equipment.9
9.1 General. 9
9.2 Draw-over vaporizer. 9
9.3 Inflating bellows . 9
9.4 Anaesthetic patient valve. 10
Annex A (normative) Test methods. 11
Annex B (informative) Diagrams of assemblies of components used in draw-over anaesthetic
systems. 14
Annex C (informative) Rationale . 17
Bibliography . 19

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ISO/TS 18835:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
 an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
 an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 18835 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
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ISO/TS 18835:2004(E)
Introduction
The continuous-flow anaesthetic system described in ISO 8835-2 to ISO 8835-5 relies upon supplies of
compressed medical gases and an uninterrupted electricity supply. These in turn depend upon a highly
developed infrastructure of transport facilities, power generation and technical service.
The World Federation of Anaesthesiologists (WFSA) has requested ISO to ensure that the needs for safe
anaesthesia for people in the populous and developing countries of the world are also addressed in ISO
standards for anaesthetic equipment. This should include a practical standard for draw-over vaporizers and
associated equipment.
In accordance with this request, this Technical Specification deals with such a system that is not dependent
on compressed gas and electrical power.
It is based on the use of ambient air, preferably with the addition of supplementary oxygen, as the carrier gas
to convey anaesthetic vapour to a patient from a draw-over vaporizer.
Attention is drawn to IEC 60601-2-13 and the ISO 8835 series of standards relating to other devices used for
inhalational anaesthesia.
Throughout this Technical Specification, text for which a rationale is provided in Annex C is indicated by an
asterisk (*).

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TECHNICAL SPECIFICATION ISO/TS 18835:2004(E)

Inhalational anaesthesia systems — Draw-over vaporizers and
associated equipment
1 Scope
This Technical Specification specifies safety and performance requirements for draw-over vaporizers and
associated equipment to provide draw-over anaesthetic systems for patients weighing greater than 15 kg
using both non-flammable and, in places where regulations permit their use, flammable anaesthetic agents.
No requirements for monitoring the equipment are given in this Technical Specification.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — 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 5360, Anaesthetic vaporizers — Agent-specific filling systems
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 8835-2:1999, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems for adults
ISO 8835-4:2004, Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices
IEC 60601-1:1988 + A1:1991 + A2:1995 and corrigendum 1995 mod, Medical electrical equipment — Part 1:
General requirements for safety
IEC/SC62A/389/CDV; 2002, Medical electrical equipment — Part 1: General requirements for safety and
performance (revision of IEC 60601-1:1988)
EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
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ISO/TS 18835:2004(E)
3.1
air/oxygen reservoir
tubular container, open to ambient air at one end, with an inlet for connection to an oxygen supply and an
outlet port through which the air/oxygen mixture passes to the draw-over vaporizer
3.2
inflating bellows device
device with unidirectional valve(s) and a connection to a concertina-type bellows
NOTE Manual operation of the bellows will cause unidirectional flow towards the patient.
3.3
inflating valve
valve that closes the expiratory pathway during the inspiratory phase of intermittent positive-pressure
ventilation
3.4
anaesthetic patient valve
APV
valve at the patient end of a draw-over anaesthetic system that has three operating functions: as a
unidirectional valve to prevent flow towards the vaporizer during exhalation, as an inflating valve to permit
intermittent positive-pressure ventilation, and as a unidirectional exhaust valve to prevent inhalation of air
through the exhaust port during spontaneous ventilation
NOTE This type of valve is similar to “non-rebreathing exhaust valve” defined in ISO 8835-2 and to “patient valve”
defined in ISO 10651-4. However, it has a combination of functions not mandated in either of the earlier definitions.
∗∗∗∗
4 Air/oxygen reservoir
4.1 Connections
4.1.1 Ambient air inlet
The ambient air inlet shall not be a conical connection complying with ISO 5356-1 or ISO 5356-2.
The ambient air inlet should be designed to reduce the risk of accidental obstruction.
Consideration should be given to provision for attaching particulate filters to reduce the risk of inhaling
particulate matter.
4.1.2 Oxygen inlet port
The oxygen inlet port shall comprise a nipple in accordance with EN 13544-2.
4.1.3 Outlet port
If operator-detachable, the outlet port shall be a 22 mm male conical connection in accordance with
ISO 5356-1 or ISO 5356-2.
4.2 Draw-over vaporizer
4.2.1 Inlet port
If operator-detachable, the inlet port shall be a 22 mm female conical connector complying with ISO 5356-1 or
ISO 5356-2.
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ISO/TS 18835:2004(E)
4.2.2 Outlet port
If operator-detachable, the outlet port shall be a 22 mm male conical connector complying with ISO 5356-1 or
ISO 5356-2.
4.3 Inflating bellows device
4.3.1 Inlet port
If operator-detachable, the inlet port shall be a 22 mm female conical connector complying with ISO 5356-1 or
ISO 5356-2.
4.3.2 Outlet port
The outlet port shall be a 22 mm male conical connector complying with ISO 5356-1 or ISO 5356-2.
4.3.3 Connection for attachment of the bellows unit to the inflating bellows device
The connection for the bellows unit shall not be a conical connector complying with ISO 5356-1 or ISO 5356-2
(see Figure B.1 for an example).
4.3.4 Connection for breathing system pressure monitor
If provided, the connection for a pressure monitor shall not be compatible with connectors specified in
EN 13544-2. It should be self-sealing or may be provided with an audible warning of disconnection, e.g. a
whistle.
4.4 Anaesthetic patient valve
4.4.1 Inlet port
The inlet port shall be a 22 mm female conical connector complying with ISO 5356-1.
4.4.2 Patient connection port
The patient connection port shall be a 22 mm male conical connector with coaxial 15 mm female conical
connector, both complying with ISO 5356-1.
∗∗∗∗
4.4.3 Exhaust port
The exhaust port shall be a 30 mm male conical connector complying with ISO 5356-1.
4.5 Connecting tubes
If provided, connecting tubes shall be anaesthetic breathing tubes complying with ISO 5367 and, if
operator-detachable, fitted at one end with a tube adaptor to provide a 22 mm male conical connector
complying with ISO 5356-1.
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ISO/TS 18835:2004(E)
5 Construction
5.1 General
∗∗∗∗
5.1.1 Components for use with flammable anaesthetic agents
All components intended to be used with flammable anaesthetic agents shall comply with Annex G of
IEC/SC62A/389/CDV:2002.
5.1.2 Materials
The materials from which all components are made shall be selected to take into account the chemical and
physical properties of any substances with which the manufacturer declares that they may come into contact
during use.
The selection procedures used for materials shall be documented and retained by the manufacturer.
NOTE Draw-over vaporizers and associated equipment have been used in areas where “normal” cleaning materials
are not available and many corrosive and abrasive materials have been substituted as cleaners. Water has also been
used to flush out draw-over vaporizers after use.
5.2 Draw-over vaporizer
5.2.1 Mechanical hazards
The requirements given in IEC 60601-1:1988, Clauses 21 to 24, apply.
5.2.2 Contents indicator
The draw-over vaporizer shall be provided with a visual indication of the level of liquid anaesthetic agent
contained within.
5.2.3 Output control
5.2.3.1 Vapour output control
A calibrated control shall be provided to adjust the vapour concentration (volume fraction). Under normal
operating conditions it shall not be possible to set the control above the calibrated range. The calibrated
control may have a separate “OFF” position in addition to a “0” or “zero” position.
5.2.3.2 Unintentional adjustment of control
Means shall be provided to prevent unintended change of the calibrated control from its set position.
Compliance is checked by visual inspection and functional testing.
5.2.4 Filler port
If the vaporizer is fitted with an agent-specific filler, the filler shall comply with the requirements of ISO 5360.
5.2.5 Prevention of overfilling
When operated in accordance with the manufacturer's instructions, it shall not be possible to overfill the
draw-over vaporizer such that
a) its performance is affected, or
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ISO/TS 18835:2004(E)
b) the fluid level is no longer visible or indicated.
Compliance is checked by visual inspection and functional testing.
5.2.6 Stability in use
The draw-over vaporizer either shall be provided with mounting fittings suitable to enable it to be rigidly
supported or shall have a base designed to provide stability when free-standing.
Compliance is checked by visual inspection and functional testing.
5.3 Air/oxygen reservoir
The oxygen inlet should be as close as possible to the inlet of the draw-over vaporizer.
A length of breathing hose complying with ISO 5367 may be used as the air/oxygen reservoir.
∗∗∗∗
5.4 Inflating bellows device
5.4.1 Bellows form
The bellows shall be designed to give a visual indication of spontaneous respiration.
∗∗∗∗
5.4.2 Unidirectional valves
A unidirectional valve shall be provided at the inlet port. If a unidirectional valve is provided at the outlet port,
means shall be provided to retain the valve in the fully open position.
Each valve shall be designed and located such that their function is visible to the operator
5.4.3 Stability in use
If free-standing, the inflating bellows device shall be provided with a base to provide stability during use. The
device shall not fall over when a force of 30 N is applied in a downward direction to the top of the bellows at
any angle up to 30° from the vertical.
5.4.4 Pressure-limiting device
A pressure-limiting device shall be provided within the gas path of the inflating bellows device (see 6.3.3).
5.5 Anaesthetic patient valve dismantling and reassembly
The valve shall be designed so that it can be dismantled without the use of a tool for cleaning, disinfection and
sterilization.
The design should aim to reduce the risk of incorrect assembly after dismantling. The valve body should
preferably be transparent to permit the internal components to be visible for checking.
6 Performance
6.1 Draw-over vaporizer
6.1.1 Output when off
When tested in compliance with A.3, the output of the vaporizer in the “0”, “off” or “zero” position shall be less
than 0,1 %.
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ISO/TS 18835:2004(E)
6.1.2 Output in use
When tested in compliance with A.3, the accuracy of output shall be within ± 20 % of set value for
concentrations (volume fraction) greater than 1 %, and ± 50 % of set value for concentrations of 1 % or below.
6.1.3 Output when fitted
If the draw-over vaporizer is designed to operate without being rigidly attached to a mounting rail, the
draw-over vaporizer output shall remain within the manufacturer's stated performance if the draw-over
vaporizer is tilted within an angle of ± 30° from the vertical.
Compliance is checked by functional testing.
6.2 Air/oxygen reservoir
When tested as described in A.4, the oxygen concentration (volume fraction) measured at the air inlet port
shall not exceed 21 %.
6.3 Inflating bellows device
6.3.1 Delivered volume
The maximum delivered volume shall be not less than 1 l.
Test by discharging into a spirometer.
6.3.2 Reverse flowrate through unidirectional valves
When tested as described in A.5, the reverse flowrate through each individual valve in the inflating bellows
device shall not exceed 60 ml/min.
6.3.3 Pressure-limiting device
The pressure-limiting device shall ensure that, under both normal conditions and single-fault condition, the
pressure at the patient connection port shall not exceed 12,5 kPa (125 cmH O).
2
6.4 Anaesthetic patient valve
6.4.1 Unidirectional function from patient to inflating bellows device
When tested as described in A.5, the reverse flowrate from the patient through the unidirectional inlet valve
component of the anaesthetic patient valve into the inflating bellows during exhalation shall not exceed
60 ml/min.
6.4.2 Unidirectional function to patient from exhaust port
When tested as described in A.5, the reverse flowrate from the exhaust port to the patient during inhalation
shall not exceed 60 ml/min.
∗∗∗∗
6.4.3 Efficiency of ventilation
The manufacturer shall disclose the range of tidal volumes over which at least 80 % of the displaced volume
from an adjustable sine-wave generator is delivered to an appropriate test lung.
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ISO/TS 18835:2004(E)
6.5 Complete system — Resistance to spontaneous inspiration and expiration
When tested as described in A.6, the resistance to inspiration shall not exceed 0,6 kPa, and the resistance to
expiration shall not exceed 0,2 kPa.
7 Arrangement of components in draw-over anaesthetic system
∗∗∗∗
7.1 Oxygen inlet
If an oxygen inlet is provided, it shall be into a reservoir open to atmosphere.
∗∗∗∗
7.2 Vaporizer
Unless otherwise stated by the manufacturer, the inflating device shall be on the patient side of the vaporizer.
NOTE Annex B provides diagrams of common arrangements of components.
8 Marking of components
8.1 General
The breathing system, as defined in ISO 4135, starts at the air inlet port and continues through the draw-over
system, terminating at the exhaust port. All components of the draw-over system, including the vaporizer, are
therefore classified as breathing-system attachments.
8.2 Marking of breathing-system attachments
All components shall be durably and legibly marked with the following:
a) the name and/or trade mark 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 of ISO 8835-2:1999, the word “EXHAUST” and/or “AGSS” or the
equivalent in the national language or an appropriate symbol;
e) 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.
f) 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.
8.3 Marking of draw-over vaporizer
8.3.1 The graduated scale of vapour output shall be marked with the generic name of the specific
anaesthetic agent, or at least with an abbreviated form from the following list:
a) “ENF” — (Enflurane)
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ISO/TS 18835:2004(E)
b) “HAL” — (Halothane)
c) “ISO” — (Isoflurane)
d) “SEV” — (Sevoflurane)
If colour coding is used, it shall be in accordance with Annex BB of ISO 8835-4:2004.
If a vaporizer is provided with interchangeable scales for more than one agent, no agent identification or
colour coding should be provided except on these scales.
8.3.2 Graduated controls shall be marked with the units in which the graduation is made.
8.3.3 Graduated controls shall be marked with “0” or “OFF” at the zero position.
8.3.4 Either the maximum and minimum filling levels shall be marked or the actual useable volume shall be
displayed.
8.3.5 The direction of operation of the control to increase the concentration (mass fraction) shall be clearly
marked.
8.4 Marking of air/oxygen reservoir
8.4.1 The air inlet shall be marked “AIR INLET — DO NOT OBSTRUCT” and/or the equivalent in the
national language.
8.4.2 The oxygen inlet shall be marked “OXYGEN” or “O ” and/or the equivalent in the national language.
2
8.5 Marking of inflating bellows device
8.5.1 If a pressure monitor connection is provided, it shall be marked “PRESSURE MONITOR” and/or the
equivalent in the national language.
8.5.2 Inflating bellows devices without an outlet unidirectional valve shall be marked “FOR USE ONLY
WITH AN ANAESTHETIC PATIENT VALVE” and/or the equivalent in the national language.
8.6 Marking of packages
Packages containing breathing attachments or complete breathing systems shall be legibly marked with the
following:
a) a description of the contents;
b) where applicable the words “FOR SINGLE USE”, and/or the equivalent in the national language or
symbol No. 1051 (indicating “do not re-use”) given in ISO 7000;
c) if appropriate, the word “STERILE” and/or the equivalent in the national language 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;
f) if applicable, recommended methods of cleaning and sterilization or disinfection, including the maximum
number of cycles recommended;
g) if the packages contain breathing attachments or complete breathing systems made of antistatic material,
the word “ANTISTATIC” and/or the equivalent in the national language shall be marked legibly on the
package.
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ISO/TS 18835:2004(E)
9 Information to be provided with equipment
9.1 General
The following information shall be provided by the manufacturer/supplier of the complete draw-over vaporizer
system:
a) instructions for assembling the complete draw-over anaesthetic system, including specifications for the
as
...