ISO 10651-1:1993
(Main)Lung ventilators for medical use — Part 1: Requirements
Lung ventilators for medical use — Part 1: Requirements
Is to be used in conjunction with IEC 601-1:1988. Specifies relevant requirements (general requirements, environmental conditions, protection against electric shock hazards, protection against excessive temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, constructional requirements, additional requirements) for lung ventilators, excluding ventilators primarily intended for anaesthesia, home care, transport, and other devices such as jet and high-frequency ventilators. The requirements of this standard take precedence over those of IEC 601-1.
Ventilateurs pulmonaires à usage médical — Partie 1: Prescriptions
General Information
Relations
Standards Content (Sample)
INTERNATIONAL
STANDARD
10651-1
First edi tion
1993-06-0 1
Lung ventilators for medical use -
Part 1:
Requirements .
Ventilateurs pulmonaires a wage medical -
Partie Ir Prescrip tions
Reference number
ISO 10651-1:1993(E)
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ISO 10651~1:1993(E)
Contents
Page
1
General . . . . . . . . . . . . . . . . .I.
Section 1
1
..,............,...............................,..............................................
1.1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Normative references
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Definitions
3
1.4 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
1.5 General requirements for tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
1.6 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .-.
. . . . . . . . . . . . . . . . .*. 4
1.7 Identification, marking and documents
6
1.8 Power Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
Section 2 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Basic safety categories
..,...........~.................................. 7
2.2 Removable protective means
7
2.3 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Special measures with respect to safety
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
2.5 Single fault condition
,,.,.,.1.1. 8
Section 3 Protection against electric shock hazards
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 General
. . . . . . . . . . . . . . . . . . . . . . . . . . . .s. 8
3.2 Requirements related to classification
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Limitation of voltage and/or energy
8
3.4 Enclosures and protective covers ,.,.,.
8
. . . .-.
3.5 Separation
3.6 Protective earthing, functional earthing and potential
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
equalization
8
3.7 Continuous leakage currents and Patient auxiliary currents
. . . . . . . . . . . .m.m. 8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.8 Dielectric strength
0 ISO 1993
All rights reserved. No part of this publication may be reproduced or utilized in any form
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Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 0 Switzerland
Printed in Switzerland
ii
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ISO 106514:1993(E)
Section 4 Protection against mechanical hazards . . . . . . . . .*.“. 9
4.1 Mechanical strength . . . . . . . .*. 9
4.2 Moving Parts
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3 Surfaces, corners and edges . ,9
4.4 Stability in normal use
............................................................. 9
4.5 Expelled Parts
........................................................................... 9
4.6 Vibration and noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
4.7 Pneumatic and hydraulic power
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.8 Suspended masses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 9
Section 5 Protection against hazards from unwanted or excessive
radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
5.1 X-radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
Alpha, beta, gamma, neutron radiation and other particle
5.2
radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
5.3 Microwave radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IO
5.4 Light radiation (including lasers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.5 Infrared radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.6 Ultraviolet radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.7 Acoustical energy (including ultrasonics) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.8 Electromagnetit compatibility . . . . . . . . . . . . . . . .*.
10
Section 6 Protection against hazards of ignition of fiammable
anaesthetic mixtures .,.,.,~.~., 11
6.1 Locations and basic requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.2 Marking, accompanying documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Common requirements for category AP and category APG
6.3
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.4 Requirements and tests for category AP equipment and Parts and
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
components 11
6.5 Requirements and tests for category APG equipment and Parts
and components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Section 7 Protection against excessive temperatures and other safety
,,,,,,.,.,,.~.,.,,,.
hazards 12
7.1 Excessive temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
7.2 Fire prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
. . .
Ill
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ISO 10651-1:1993(E)
7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
7.4 Pressure vessels and Parts subject to pressure
. . . . . . . . . . . . . . . . 13
7.5 Human error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
7.6 Electrostatic charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
7.7 Materials in applied Parts in contact with the body of the
Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
13
7.8 Interruption of power supply
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 13
Section 8 Accuracy of operating data and protection against
hazardous output .1.*.,.,. 14
8.1 Accuracy of operating data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.2 Protection against hazardous output
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Section 9 Abnormal Operation and fault conditions; environmental
tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
17
9.1 Abnormal Operation and fault conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
9.2 Environmental tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Section 10 Constructional requirements . . . . . . . . . . . . . . . . . .1. 18
10.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.2 Enclosures and covers
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.3 Components and general assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.4 Mains park, components and layout 19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5 Protective earthing - Terminals and connections . . . . . . . . . . , 20
10.6 Construction and layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Section 11 Additional requirements .1.11,.11.,,.1.~. 21
11.1 Additional alarm requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
11.1.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
21
11.1.2 Alarm activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
11.1.3 Muting and cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
11.1.4 Ventilator breathing System alarms
21
11.1.5 High temperature alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iv
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ISO 106!51=1:1993(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, govern-
mental 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 Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard ISO 106514 was prepared by Technical Commit-
tee ISO/TC 121, Anaesthetic and respiratory equipment, Sub-Committee
SC 3, Lung ventiiators and related equipment.
This fit-st edition of ISO 10651-1 cancels and replaces the first edition of
of ISO 5369, published in 1988, and IEC 601-2-12:1988, of both of which
it constitutes a technical revision and amplification.
ISO 10651 consists of the following Parts, under the general title Lung
ventilators for medical use:
- Part 1: Requirements
- Part 2: Particular requirements for home care ventilators
transport
- Part 3: Particular requiremen ts for emergency
ven tila tors
V
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~--~- -
ISO 106514:1993(E)
INTERNATIONAL STANDARD
Lung ventilators for medical use -
Part 1:
Requirements
Section 1: General
IEC and ISO maintain registers of currently valid
1.1 Scope
International Standards.
ISO 10651 is one of a series of International Stan-
ISO 32:1977, Gas cylinders for medical use - Mark-
dards based on IEC 601-1:1988. In IEC 601-1:1988
ing for identification of content.
(the “General Standard”), this type of International
Standard is referred to as a “Particular Standard”.
ISO 4135:1979, Anaesthesiology - Vocabulary.
As stated in 1.3 of IEC 601-1:1988, the requirements
of this International Standard take precedence over
ISO 5356-1 :1987, Anaesthetic and respiratory equip-
those of IEC 60%1:1988.
ment - Conical connectors - Part 1: Cones and
sockets.
This International Standard is a revision and ampli-
fication of IEC 60%2-12:1988, Medical electrical
equipmen t - Part 2: Particular requirements for the ISO 5356-2: 1987, Anaesthetic and respiratory equip-
safety of lung ventilators for medical use. lt includes ment - Conical connectors - Part 2: Screw-
requirements from ISO 5369:1988 and replaces both threaded weight-bearing connectors.
documents.
ISO 5359:1989, Low-pressure f7exible connecting as-
The scope and Object given in clause 1 of
semblies Chose assemblies) for use with medical gas
IEC 60%1:1988 applies except that 1.1 shall be re-
Systems.
placed by the following:
ISO 5362:1986, Anaesthetic reservoir bags.
This part of ISO 10651 specifies requirements for
lung Ventilators intended for medical use, excluding
ISO 5367:1991, Breathing tubes intended for use with
Ventilators primarily intended for anaesthesia, home
anaesthetic apparatus and ventilators.
care, transport, and other devices such as jet and
high-frequency Ventilators.
ISO 7767:1988, Oxygen analyzers for moniforing pa-
tient breathing mixtures - Safety requirements.
1.2 Normative references
ISO 8185:1988, Humidifiers for medical use - Safety
requirements.
The following Standards contain provisions which,
through reference in this text, constitute provisions
ISO 9360:1992, Anaesthetic and respiratory equip-
of this part of ISO 10651. At the time of publication,
ment - Heat and moisture exchangers for use in
the editions indicated were valid. All Standards are
humidifying respired gases in humans.
subject to revision, and Parties to agreements based
on this part of ISO 10651 are encouraged to investi-
ISO 9703~1:1992, Anaesthesia and respiratory care
gate the possibility of applying the most recent edi-
alarm Signals - Part 1: Visuai alarm Signals.
tions of the Standards indicated below. Members of
---------------------- Page: 7 ----------------------
ISO 106514:1993(E)
IEC 65:1985, Safety requirements for mains operated
1.3.9 expiratory Phase: Interval from the Start of
elecfronic and related apparatus for household and
expiratory flow to the Start of inspiratory flow.
similar general use.
1.3.10 flow-direction-sensitive component: Com-
IEC 6014 3988, Medical electrical equipment -
ponent through which the gas flow has to be in one
Part 1: General requiremen ts.
direction only for its proper functioning and/or pa-
tient safety.
IEC 80%2:1991, Elecfromagnetic compatibility for
industrial-process measurement and control equip-
1.3.11 fresh gas: Gas supplied to the lung Ventilator
ment - Part 2: Elec tros ta tic discharge requiremen ts.
breathing System. lt excludes the following:
a) air drawn through the emergency air intake port;
1.3 Definitions
b) air drawn through leaks in the Ventilator breath-
ing System;
For the purposes of this part of ISO 10651, the defi-
nitions given in clause 2 of IEC 601-1:1988 apply ex-
c) expired gas from the Patient.
cept that the definition given in 2.1.5 shall be
replaced by the following?
1.3.12 fresh gas Input port: Gas input port to which
[2.1.5] applied Part:‘) All Parts of the Ventilator in- fresh gas is supplied.
tended to be connected to the Patient or to the
NOTE 1 There may be more than one fresh gas input
breathing System.
port.
For the purposes of this part of ISO 10651, the fol-
lowing additional definitions also apply. 1.3.13 fresh gas intake port: Gas intake port, other
than the emergency air intake port, through which
fresh gas may be drawn into the Ventilator breathing
1.3.1 bacterial filter: Device intended to reduce
System by the lung Ventilator or the Patient.
bacteria content and particulate matter content of
the gas stream.
1.3.14 gas exhaust port: Port of the lung Ventilator
from which gas is discharged to the atmosphere ei-
1.3.2 calibrated control: Control with numbered
ther directly or via an anaesthetic gas scavenging
marks in which the numbers purport to indicate the
System.
value of the Parameter being controlled, whether or
not the control has been individually calibrated.
1.3.15 gas input port: Port to which gas is supplied
under positive pressure and through which the gas
1.3.3 clearly legible: Visual attribute of informat’ion
is driven by this pressure.
displayed by the equipment that allows the Operator
to discern (or identify) qualitative or quantitative
NOTES
values or functions under a specific set of environ-
mental conditions.
2 The gas may be supplied either at a controlled pres S-
ure and/or at a controlled flow.
1.3.4 cycling pressure: Pressure in the Ventilator
3 c.f. gas intake Port.
breathing System which initiates an inspiratory or
expiratory Phase.
1.3.16 gas lntake port: The port through which gas
is drawn into the Ventilator breathing System by the
1.3.5 driving gas:
Gas which powers the lung
lung Ventilator or the Patient.
Ventilator but is not necessarily delivered to the pa-
tient.
NOTES
1.3.6 driving gas input po& Gas input port to which
4 Gas may be supplied to the port at or about ambient
driving gas is supplied.
atmosphere or end-expiratory pressure, or the port may
simply be left open to the atmosphere.
1.3.7 emergency air lntake port: Dedicated gas in-
5 In a Ventilator breathing System, energy is required to
take port through which ambient air may be drawn
reduce the pressure below that of the atmosphere.
when the supply of fresh and/or inflating gas is in-
Therefore, when gas is supplied at or about atmospheric
sufficient.
pressure to a gas intake Port, work has to be done, either
by the lung Ventilator (using energy from, for example, an
1.3.8 expired tidal volume: Volume of gas leaving
electrical supply or a driving gas supply) or by the Patient
the patient’s lungs during an expiratory Phase. in Order to lower the breathing System pressure suf-
1) See also annex L in this part of ISO 10651.
2
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ISO 10651=1:1993(E)
ficiently for gas to flow in through the gas intake Port. In NOTE 7 Even if not adjustable, this maximum may be
this sense, gas is “drawn” into the breathing System. A less than the maximum limited pressure.
similar argument applies, even if gas is supplied to the
gas intake port at a small positive pressure to compen-
1.3.28 minimum limlted pressure, Piim min: Lowest
sate for the use of positive end-expiratory pressure.
(most negative) pressure measured at’ the Patient
connection port, which tan be attained in the
1.3.17 gas output Port: Port of a lung Ventilator
Ventilator breathing System during malfunction of
through which gas is delivered through a tube to the
the Ventilator but with a functioning safety mech-
Patient connection Port.
anism.
See note 6.
NOTE 8
1.3.18 gas return port: Port of the lung Ventilator
through which gas is returned at respiratory press-
1.3.29 minimum working pressure, Pw min: Lowest
ures through a tube from the Patient connection
(most negative) pressure which tan be’ attained at
.
Port
the Patient connection port during the expiratory
Phase, irrespective of the setting of controls other
1.3.19 high pressure gas input port: Gas input port
than any control intended to adjust this pressure,
to which gas is supplied at a pressure greater than
with the Ventilator working normally.
100 kPa.
1.3.30 operator’s Position: Intended orientation of
1.3.20 inflating gas: Fresh gas which powers the
the Operator with respect to the equipment for
lung Ventilator and is supplied to the Patient.
normal use according to the instructions for use.
1.3.21 inflating gas input port: Gas input port to
1.3.31 Patient connectlon port (of the Ventilator
which inflating gas is supplied.
breathing System): Port of the Ventilator breathing
System to which the Patient may be connected.
1.3.22 inspiratory Phase: Interval from the Start of
inspiratory flow to the statt of expiratory flow.
1.3.32 triggering: Initiation of the inspiratory Phase
of the lung Ventilator by the inspiratory effort of the
Patient.
1.3.23 low pressure gas input port: Gas input port
to which gas is supplied at a pressure not exceeding
1.3.33 Ventilation, R Volume of gas per minute en-
100 kPa.
tering or leaving the patient’s lungs.
1.3.24 lung Ventilator: Any device which is intended
1.3.34 Ventilator breathing System (VBS): Breathing
to augment automatically or provide Ventilation of
System bounded by the low pressure gas input
the patient’s lungs when connected to the patient’s
port(s), the gas intake port(s) and the Patient con-
airway, referred to as a Ventilator throughout this
nection port together with the fresh gas inlet and
document.
exhaust port(s), if these are provided.
1.3.25 manual ventilation port: Port of the Ventilator
NOTES
to which a device may be connected for manual in-
flation of the lungs.
9 Attention is drawn to the definition of a breathing sys-
tem in ISO 4135.
1.3.26 maxlmum limited pressure, I’lim max: Highest
10 Gas supplied to the Ventilator at any gas input port
pressure measured at the Patient connection port
enter the Ventilator breathing System at any Point.
maY
which tan be attained in the Ventilation breathing
System during malfunction of the Ventilator but with
Valves may be placed anywhere in relation to ports
11
a functioning safety mechanism.
and, indeed, anywhere in the Ventilator breathing System,
provided the requirements of this part of ISO 10651 are
met.
NOTE 6 Components of a Ventilator are operating
normally when individually they operate as the manufac-
turer intended, even though particular combinations of
settings of controls and of the compliance and resistance 1.4 General requirements
of the patient’s respiratory tract may lead to an inappro-
priate Pattern of Ventilation.
The general requirements given in clause 3 of
IEC 60%1:1988 apply with the following addition:
1.3.27 maximum worklng pressure, Pw max: Highest
pressure which tan be attained at the ‘Patient con- 3.6j) Applicable Single fault conditions are short-
nection port during the inspiratory Phase, irrespec- and open-circuits of components of wiring which
tive of the setting of controls other than any control tan
intended to adjust this pressure, with the Ventilator
working normally.
- Cause Sparks to occur, or
3
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ISO 10651~1:1993(E)
ab) Any high pressure gas input port shall be
- increase the energy of Sparks, or
marked in accordance with ISO 5359.
- increase temperatures.
ac) If Parts are marked, the following terms shall
be used at least in the national language or
A Single fault condition shall not Cause a moni-
English. Alternatively, Symbols may be used
toring and/or alarm device as in 8.2 and 11.1, and
and explained in the instructions for use:
the corresponding Ventilation control function
shall not fail in such a way that the monitoring
1 Driving gas input port: “driving gas in-
function becomes simultaneously ineffective, and
Jl
Put
thus fails to detect the loss of the monitored
Ventilator function.
2 Inflating gas input Port: “inflating gas
input” or “driving and fresh gas input”,
Test for compliance by Simulation of a Single
as appropriate
fault condition or by visual inspection.
3 Fresh gas input port: “fresh gas”
1.5 General requirements for tests
4 Fresh gas intake port: “fresh gas
intake”
The requirements given in clause 4 of IEC 601-1:1988
5 Emergency air intake port: “WARNING:
aPPlY l
emergency air intake - do not
obstruct”
1.6 Classification
6 Manual Ventilation port: “bag”
The classification given in clause 5 of IEC 601-1:1988
7 Gas output port: “gas output”
applies.
8 Gas return port: “gas return”
NOTE 12 A Ventilator may have applied Parts of differ-
ent types.
9 Gas exhaust port: “exhaust”. If the vol-
ume of gas discharged from the exhaust
port is either more or less than the ex-
1.7 Identification, marking and documents
pired volume, additionally: “not for
spirometer”
The requirements given in clause 6 of IEC 601-1:1988
apply except for the following additions and modifi-
ad) A Checklist indicating the procedures to be
cations.
carried out by the user immediately before
use shall be permanently attached to the
a) Amend 6.1 e) as follows:
Ventilator. The use of electronie displays,
e.g. a CRT, is permitted.
The address of the manufacturer and/or author-
ized representative, as applicable, shall also be
ae) If auxiliary mains socket outlet(s) tan accept
marked.
a mains plug, the auxiliary mains socket
outlet(s) shall be marked with Symbol 14
b) Amend 6.1 j) as follows:
given in table Dl in Appendix D of
IEC 601-1:1988.
The power input marking shall be given in am-
peres for the Ventilator and for the sum of the
af) If gas-specific colour coding of flow controls
current ratings for the Ventilator and auxiliary
and flexible hoses is provided, it shall be in
mains socket outlets.
accordance with ISO 32.
c) Amend 6.1 k) as follows:
ag) Packages containing breathing attachments
intended for Single use shall be clearly
The requirement for marking of auxiliary mains
marked with the following:
socket outlets shall apply to each auxiliary mains
socket outlet and the maximum allowed output a description of the contents;
a)
shall be marked in amperes.
b) the words “Single Patient use”;
d) In 6.1, add the following items:
given in
NOTE 13 Symbol No. 1051
ISO 7000 may additionally be used.
aa) All operator-accessible flow-direction-
sensitive components, unless non-
c) the words “sterile” or “non-sterile”, as
interchangeable, shall be permanently
applicable;
marked with a clearly legible arrow indicat-
ing the direction of flow.
4
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ISO 10651=1:1993(E)
d) the name and/or trademark of the 5 if auxiliary mains socket outlet(s) accept a
manufacturer and/or supplier; Standard mains plug, a warning related to
the Symbol required in item ac) of 6.1 to the
an identification reference to the type,
e)
effect that the connection of equipment to
batch, serial number or date of manu-
the auxiliary mains socket outlet(s) may in-
facture.
crease the Patient leakage currents to val-
ues exceeding the allowable limits in the
Packages containing breathing attachments
ah)
event of a defective ear-th conductor,
intended for re-use shall be clearly marked
with the following:
6 the intended use of the Ventilator (e.g. in-
tensive therapy, adult, paediatric, neonatal),
a description of the contents;
a)
7 if the lung Ventilator is fitted with a gas mix-
b) the name and/or trademark of the
ing System, the manufacturer shall disclose
manufacturer and/or supplier;
the following:
recommended methods of cleaning,
Cl
a) the recommended range of flows from
disinfection and sterilization;
the mixing System,
NOTE 14 Some breathing attachments
the leakage from one gas System to the
W
may contain these recommended methods
other,
in the instructions for use.
c) the design pressure and any pressure
ai) Packages containing breathing attachments
differential,
made of conductive materials shall be
clearly marked with the word “conductive”
f) .In 6.8.3, add the following to item a):
or “antistatic”.
The technical description shall additionally in-
e) In 6.8.2a), add the following:
clude disclosure of all information necessary to
check that the lung Ventilator is installed cor-
1 a Statement to the effect that antistatic
rectly an
...
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