SIST EN ISO 8359:2000
(Main)Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
ISO 8359 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 601-1:1998, 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 safety requirements for continous-flow oxygen concentrators. This International Standard does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents. The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing absorbes, as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.
Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen (ISO 8359:1996)
ISO 8359 gehört zu einer Reihe von Internationalen Normen, die auf der IEC 601-1 basieren. In IEC 601-1 (der "Allgemeinen Norm") wird diese Art Internationaler Norm als "Besondere Festlegungen" bezeichnet. Wie in 1.3 der IEC 601-1:1988 festgelegt, haben die Anforderungen dieser Internationalen Norm Vorrang vor denen der IEC 601-1. Der Anwendungsbereich nach Abschnitt 1 von IEC 601-1:1988 gilt mit der Ausnahme, daß 1.1 durch folgendes ersetzt werden muß.
Concentrateurs d'oxygene a usage médical - Prescriptions de sécurité (ISO 8359:1996)
Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve (ISO 8359:1996)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8359:2000
01-januar-2000
Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve (ISO
8359:1996)
Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen (ISO
8359:1996)
Concentrateurs d'oxygene a usage médical - Prescriptions de sécurité (ISO 8359:1996)
Ta slovenski standard je istoveten z: EN ISO 8359:1996
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8359:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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INTERNATIONAL
IS0
STANDARD
8359
Second edition
1996-l 2-l 5
Oxygen concentrators for medical use -
Safety requirements
Concentrateurs d’oxyghe 2 usage mgdical - Prescriptions de s6curit6
Reference number
IS0 8359: 1996(E)
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IS0 8359: 1996(E)
Contents
Page
1
Section 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
1 .I Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
1.2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Definitions
................................ ............................. 2
I .4 General requirements
O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
I.5 General requirements for tests
2
1.6 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Identification, marking and documents . . .*. 2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.8 Power input
. . . .D.‘. 6
Section 2 Safety requirements
6
2.1 Basic safety categories ~.~.
....................................... ......... 6
2.2 Removable protective means
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Environmental conditions . . . . .
. . . . . . . . . . . . . . . . 7
Protection against electric shock hazards
Section 3
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 General
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Requirements related to classification
............ 7
...........................
3.3 Limitation of voltage and/or energy
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Enclosures and protective covers
7
3.5 Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Protective earthing, functional earthing and potential
7
equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 7
Continuous leakage currents and patient auxiliary currents
3.7
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
3.8 Dielectric strength
. . . . .*. 8
Protection against mechanical hazards
Section 4
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Mechanical strength
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
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0 IS0
IS0 8359: 1996(E)
4.2 Moving parts . . 8
4.3 Surfaces, corners and edges . . . 8
4.4 Stability in normal use . . . . 8
4.5 Expelled parts .
............................ ...................................... 8
4.6 Vibration and noise
....................................... .......................... 8
Pneumatic and hydraulic power
4.7 . 8
4.8 Suspended masses . . 8
Section 5 Protection against hazards from unwanted or excessive
radiation . .~.” . 9
5.1 X-Radiation . . . . 9
5.2 Alpha, beta, gamma, neutron radiation and other particle
radiation . . . . 9
5.3 Microwave radiation . . 9
5.4 Light radiation (including visual radiation and lasers) . 9
5.5 Infrared radiation . . . 9
5.6 Ultraviolet radiation . . 9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Section 6 Protection against hazards of expli osions in medically
used rooms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Locations and basic requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
6.1
10
6.2 Marking, accompanying documents . . . . . . . . . . . . . . D . . . . . . . . . . . . . . . . . . . . .
6.3 Common requirements for category AP and category APG
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
6.4 Requirements and tests for category AP equipment, parts and
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
components thereof
6.5 Requirements and tests for category APG equipment, parts and
components thereof . . . . . . . . . . . . . . . .I. IO
Protection against excessive temperatures and other
Section 7
safety hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
.................................................
7.1 Excessive temperatures . 11
7.2 Fire prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.4 Pressure vessels and parts subject to pressure . . . . . . . . . . . . . . . . . .
12
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0 IS0
IS0 8359:1996(E)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.5 Human errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with the body of the
12
patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.8 Interruption of the power supply
Section 8 Accuracy of operating data and protection against
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
hazardous output
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.1 Accuracy of operating data
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.2 Protection against hazardous output
Abnormal operation and fault conditions; environmental
Section 9
16
tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
9.1 Abnormal operation and fault conditions
16
Environmental tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.2
. . . . . .m.*. 17
Constructional requirements
Section 10
I7
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1
I7
Enclosures and covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.3 Components and general assembly
. . . . . . . . . . . . . . . . . . .“. 17
10.4 Mains parts, components and layout
. . . . . . . . . . . 17
10.5 Protective earthing - Terminals and connections
17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6 Construction and layout
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional clauses
Section 11
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
11 .l Auditory indicators
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11.2 Indication of loss of mains power
Annexes
................................................................................ 20
N Test apparatus
21
......................................................................
P Rationale statement.
24
....................................................................................
Q Bibliography
iv
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0 IS0
IS0 8359: 1996(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(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 IS0 8359 was prepared by Technical Committee
lSO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition
(IS0 8359:1988), which has been technically revised.
Annexes A to N form an integral part of this International Standard. An-
nexes P and Q are for information only.
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0 IS0
IS0 8359: 1996(E)
Introduction
Oxygen concentrators provide a safe source of oxygen-enriched air for
patients in need. These devices raise the level of inspired oxygen by sep-
arating nitrogen or oxygen from ambient air.
Oxygen concentrators fall into two main classes according to the means
whereby gas separation is effected, namely:
a) oxygen concentrators in which oxygen selectively permeates or
transports through a membrane or lattice,
b) pressure swing absorbers (PSA) in which air is exposed at a certain
pressure to molecular sieve material which selectively retains nitrogen
and other components until they are subsequently released when the
pressure is reduced.
Details of the arrangement of test apparatus for carrying out a number of
the tests to check compliance with certain requirements are given in an-
nex N.
A rationale for the most important requirements is given in annex P. It is
considered that a knowledge of the reasons for the requirements will not
only facilitate the proper application of this International Standard, but will
expedite any subsequent revision.
Test methods other than those specified in this International Standard, but
of equal or greater accuracy, may be used to verify compliance with the
given requirements. However, in the event of a dispute, the methods
specified in this International Standard are to be used as the reference
methods.
VI
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INTERNATIONAL STANDARD 0 IS0
IS0 8359: 1996(E)
Oxygen concentrators for medical use
- Safety
requirements
Section I: General
1.1 Scope
NOTE 1 See the rationale in annex P.
IS0 8359 is one of a series of International Standards based on IEC 601-I. In IEC 601-I (the “General
Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in 1.3 of
IEC 601-I :1988, the requirements of this International Standard take precedence over those of IEC 601-I.
The scope and object given in clause 1 of IEC 601-I :I 988 apply, except that 1.1 shall be replaced by the following:
This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined
in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators in-
tended to supply gas to several patients via a piped medical gas installation or to those intended for use in the
presence of flammable anaesthetic and/or cleaning agents.
The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing
absorbers (see Introduction), as alternative methods of concentrating oxygen may become available and it is not
intended that this International Standard should restrict future developments.
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 IS0 maintain
registers of currently valid International Standards.
- Determination of sound power levels of noise sources using sound pressure - En-
I SO 3744: 1994, Acoustics
gineering method in an essentially free field over a reflecting plane.
IS0 9703-I :I 992, Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals.
IS0 9703-2: 1994, Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals.
- Part 1: General requirements for safety.
I EC 601-I : 1988, Medica/ electrica/ equipment
- Part 1: General requirements for safety. 2. Collateral standard:
I EC 601-I -2: 1993, Medical electrica/ equipment
Electromagnetic compatibility requirements and tests.
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IS0 8359:1996(E)
I EC 651: 1979, Sound level meters.
1.3 Definitions
For the purposes of this International Standard, the definitions given in clause 2 of IEC 601-l :I988 apply, except
that the definition given in 2.1.5 shall be replaced by the following:
2.1.5 applied part: Oxygen concentrator outlet.
For the purposes of this International Standard, the following definitions also apply:
1.3.1 administration accessories: All accessories for conducting the product gas from the oxygen concentrator
outlet to the patient, but excluding any fixed tubing extensions.
1.3.2 oxygen concentrator outlet: Port of the oxygen concentrator from which the product gas flows.
1.3.3 flow control device: Device which controls the flow of the product gas.
1.3.4 flow indicator: Device which shows the volume of product gas passing through the oxygen concentrator
in a specified unit of time.
operator control: Contro I to enable the user, without the need for tools, to cause the oxygen concentrator
1.3.5
t-form its intended fu nction.
to pe
1.3.6 outlet pressure: Gauge pressure at the oxygen concentrator outlet under the test flow conditions.
1.3.7 oxygen analyzer: Device which measures and quantitatively indicates the concentration of oxygen present
in a gaseous mixture.
Device which, by selective removal of constituents of ambient air, increases the
1.3.8 oxygen concentrator:
product gas.
concentration of oxygen in the
1.3.9 product gas: Output from the oxygen concentrator consisting of respirable oxygen-enriched air.
1.3.10 oxygen concentration status indicator (OCSI): Device which indicates when the proportion of oxygen
in the product gas is at an abnormal level.
1.4 General requirements
The requirements given in clause 3 of IEC 601-I :I 988 apply.
1.5 General requirements for tests
The requirements given in clause 4 of IEC 601-I :I 988 apply.
1.6 Classification
The classification given in clause 5 of IEC 601-I :I988 applies, except for the following deletions.
- Delete 5.5.
- In 5.6 delete all except for “continuous operation” and “intermittent operation”.
1 .J Identification, marking and documents
The requirements given in clause 6 of IEC 601-I :I 988 apply, except for the following additions and modifications.
2
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0 IS0
IS0 8359: 1996(E)
- The foilowing additional general requirement also applies.
All markings pertaining to the operation of the oxygen concentrator shall be legible to an operator having
visual acuity, corrected if necessary, of at least I,0 and seated or standing 1 m from the oxygen
concentrator flooded with illuminance of 215 lux.
NOTE 2 All markings should have a luminance contrast of at least 50 % when compared with the surrounding
background material.
- In 6.1 e) add the following.
The oxygen concentrator shall be marked with its country of origin plus the address of the manufacturer.
- Delete 6.1 r)
- To 6.1 add the following additional items.
The marking on the outside shall additionally include the following:
1) a warning against removal of the cover by unauthorized persons;
2) a warning “NO SMOKING OR NAKED FLAMES”;
3) the nominal concentration of oxygen in the product gas, expressed as a percent volume fraction, at a
flowrate of 2 I/min or at the recommended maximum flowrate;
4) the statement “USE NO OIL OR GREASE”;
5) on the flow indicator, the output (e.g. output, gas flow, etc.).
- Replace 6.7 a) by the following.
If visual indicators are used on the oxygen concentrator, with the exception of alphanumeric displays, their
colouring shall conform to IS0 9703-I and the following additional requirements:
1) continuous red shall be used to indicate to the operator that the oxygen concentrator, or a portion of it,
has failed;
2) the function of all lights and displays shall be marked.
Compliance shall be checked by functional test and inspection.
- In 6.8.2a), add the following.
Instructions for use shall also include the following information:
1) intended use of the oxygen concentrator;
at least one type of humidifier which is suitable for use with the oxygen concentrator when needed;
a
statement that use of certain humidifiers and administration accessories not specified for use with this
oxygen concentrator may impair the performance;
4) preferred location of any humidifier in the administration accessories;
5) statement that in certain circumstances oxygen therapy can be hazardous and that seeking medical
advice before using the machine is advisable;
3
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0 IS0
IS0 8359: 1996(E)
6) statement of the time required from switching on the oxygen concentrator to reach a stated perform-
ance;
statement that the air intake of the oxygen concentrator should be located in a well-ventilated space;
7)
intervals at which cleaning procedures need to be performed and the items required for such cleaning;
8)
statement that no lubricants are to be used other than those recommended by the manufacturer;
9)
statement that advises the operator of actions to take when the oxygen concentration status indicator
10)
indicates an abnormal oxygen concentration level;
statement that the oxygen concentrator should be located so as to avoid pollutants or fumes.
11)
- In 6.8.2d), add the following.
Instructions for use shall also include the following information:
A specification for at least one complete set of administration accessories which is suitable for use with the
oxygen concentrator and, except for administration accessories, intended for single use, recommendations
for their cleaning, sterilization and disinfection.
- In 6.8.3a), add the following.
The technical description shall also include the following information:
1) table or graph showing values of oxygen concentration as a function of flowrate at specified operator
settings at a nominal outlet pressure of zero;
2) maximum recommended flow, expressed in litres per minute;
3) flowrate, expressed in litres per minute, at a specified control setting at nominal outlet pressures of zero
and 7 kPa;
4) maximum outlet pressure when the oxygen concentrator is operated in accordance with the method
given in new clause 50.8 presented in this International Standard;
5) maximum A-weighted sound pressure level, expressed in decibels, when the oxygen concentrator is
operated under the test conditions specified in new clause 26.2 presented in this International Standard;
6) if a pressure relief mechanism is provided, the range of pressures, expressed in kilopascals, at which
the mechanism operates;
7) nominal concentration of oxygen in the product gas, expressed as a percent volume fraction, at a
flowrate of 2 l/min or at the recommended maximum flowrate;
8) statement of the concentration of oxygen in the product gas, expressed as a percent volume fraction,
at the maximum recommended flowrate;
9) statement of the oxygen concentration (with tolerances) at which the OCSI gives an indication of ab-
normal oxygen concentration in the product gas;
10) statement of the ranges of temperature and atmospheric pressure at which the OCSI is intended for
use;
temperature range within which the oxygen concentrator is intended to be operated;
12) variation of oxygen concentration with flowrate over a barometric pressure corresponding to the alti-
tude range 0 to 4000 m above sea level.
4
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IS0 8359: 1996(E)
0 IS0
1.8 Power input
The requirements given in clause 7 of IEC 601-I :I 988 apply.
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IS0 8359: 1996(E)
Section 2: Safety requirements
2.1 Basic safety categories
The requirements given in Appendix Al .2 of IEC 601-I :I 988 do not apply, as they are not relevant to oxygen
concentrators.
2.2 Removable protective means
The requirements given in clause 6.1 z) of IEC 601-I :I 988 apply.
2.3 Environmental conditions
The requirements given in clause 10 of IEC 601-I :I 988 apply.
6
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IS0 8359: 1996(E)
Section 3: Protection against electric shock hazards
3.1 General
The requirements given in clause 13 of IEC 601-I :I 988 apply.
3.2 Requirements related to classification
The requirements given in clause 14 of IEC 601-I :I 988 apply.
Limitation of voltage and/or energy
3.3
The requirements given in clause 15 of IEC 601-I :I 988 apply.
3.4 Enclosures and protective covers
The requirements given in clause 16 of IEC 601-I :I 988 apply.
3.5 Separation
The requirements given in clause 17 of IEC 601-I :I 988 apply.
3.6 Protective earthing, functional earthing and potential equalization
The requirements given in clause 18 of IEC 601-I :I 988 apply.
3.7 Continuous leakage currents and patient auxiliary currents
The requirements given in clause 19 of IEC 601-I :I 988 apply.
3.8 Dielectric strength
The requirements given in clause 20 of IEC 601-I :I 988 apply.
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IS0 8359: 1996(E)
Section 4: Protection against mechanical hazards
4.1 Mechanical strength
The requirements given in clause 21 of IEC 601-I :I 988 apply, except that 21.3 shall be deleted.
4.2 Moving parts
The requirements given in clause 22 of IEC 601-I :I 988 apply.
4.3 Surfaces, corners and edges
The requirements given in clause 23 of IEC 601-I :I 988 apply.
4.4 Stability in normal use
The requirements given in clause 24 of IEC 601-I :I 988 apply.
4.5 Expelled parts
The requirements given in clause 25 of IEC 601-I :I 988 apply.
4.6 Vibration and noise
Clause 26 of IEC 601-I :I 988 shall be replaced by the following requirements.
26.1 In normal use the maximum A-weighted sound pressure level (steady or peak value) of the oxygen
concentrator shall not exceed 60 dB.
Compliance shall be checked by the test specified in 26.2.
26.2 Place the microphone of a sound level meter complying with the requirements for a type 1 instrument
specified in IEC 651 at the position of maximum sound pressure level in the horizontal plane passing through
the geometric centre of the oxygen concentrator at a radius of 1 m. The measured sound pressure level shall
not exceed the specified value.
For this test, the oxygen concentrator shall be operated over its normal working range of flow, including the
maximum flowrate recommended by the manufacturer. Measurements shall be taken using the frequency-
weighting characteristic A and the time-weighting characteristic F on the sound level meter. The measurements
shall be taken in a free field over a reflecting plane as specified in IS0 3744.
The A-weighted background level of extraneous noise shall be at least 10 dB below that measured during the
test.
4.7 Pneumatic and hydraulic power
The requirements given in clause 27 of IEC 601-I :I 988 apply.
4.8 Suspended masses
The requirements given in clause 28 of IEC 601-I :I 988 apply.
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Protection against hazards from unwanted or excessive
Section 5:
radiation
5.1 X-Radiation
The requirements given in clause 29 of IEC 601-I :I 988 apply.
5.2 Alpha, beta, gamma, neutron radiation and other particle radiation
The requirements given in clause 30 of IEC 601-I :I 988 apply.
5.3 Microwave radiation
The requirements given in clause 31 of IEC 601-I :I988 apply.
5.4 Light radiation (including visual radiation and lasers)
The requirements given in clause 32 of IEC 601-I :I 988 apply.
5.5 Infrared radiation
The requirements given in clause 33 of IEC 601-I :I 988 apply.
5.6 Ultraviolet radiation
The requirements given in clause 34 of IEC 601-I :I988 apply.
5.7 Acoustical energy (including ultrasonics)
The requirements given in clause 35 of IEC 601-I :I988 apply.
5.8 Electromagnetic compatibility
The requirements given in clause 36 of IEC 601-I :I 988 apply. In addition the requirements given in
I EC 601-I -2: 1992 apply.
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0 IS0
IS0 8359: 1996(E)
Section 6: Protection against hazards of explosions in medically used
rooms
6.1 Locations and basic requirements
The requirements given in clause 37 of IEC 601-I :I 988 do not apply, as oxygen concentrators intended for use in
the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.
6.2 Marking, accompanying documents
The requirements given in clause 38 of IEC 601-I :I988 do not apply, as oxygen concentrators intended for use in
the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.
6.3 Common requirements for category AP and category APG equipment
The requirements given in clause 39 of IEC 601-I :I 988 do not apply, as oxygen concentrators intended for use in
the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.
6.4
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