EN ISO 10079-1:2009

SLOVENSKI STANDARD
01-maj-2009
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SIST EN ISO 10079-1:2000
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Medical suction equipment - Part 1: Electrically powered suction equipment - Safety
requirements (ISO 10079-1:1999)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte -
Sicherheitsanforderungen (ISO 10079-1:1999)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration -
Prescriptions de sécurité (ISO 10079-1:1999)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10079-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 10079-1:1999
English Version
Medical suction equipment - Part 1: Electrically powered suction
equipment - Safety requirements (ISO 10079-1:1999)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch betriebene
électriques d'aspiration - Prescriptions de sécurité (ISO Absauggeräte - Sicherheitsanforderungen (ISO 10079-
10079-1:1999) 1:1999)
This European Standard was approved by CEN on 24 February 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 10079-1:1999 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10079-1:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directives.
For relationship with EC Directives, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10079-1:1999 has been approved by CEN as a EN ISO 10079-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 - Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
All 1, 2, 3, 4, 6
nd st
- 1 (2 paragraph, 1 dash) This relevant Essential
Requirement is not addressed in
this European Standard
nd nd
- 1 (2 paragraph, 2 This relevant Essential
dash) Requirement is not addressed in
this European Standard
- 6a This relevant Essential
Requirement is not addressed in
this European Standard
6 9.1, 13
nd
6 7.5 (2 paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
- 12.1a) This relevant Essential
Requirement is not addressed in
this European Standard.
6.1 e) This relevant Essential
13.3 (a):
Requirement is not fully addressed
in this European Standard
6.1 This relevant Essential
13.3 (f)
Requirement is not fully addressed
in this European Standard
6 (6.1 p), 6.3 c)) 12.9
rd
6.8.2 7.5 (3 paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
Table ZA.1 - Correspondence between this European Standard and EU Directives (continued)

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
nd
6.8.2 This relevant Essential
13.6 (h)(2 paragraph)
Requirement is not fully addressed
in this European Standard
6.8.2 This relevant Essential
13.6 (q)
Requirement is not addressed in
this European Standard: covered
by EN ISO 13485: 2003, subclause
4.2.3
9 12.6
10 12.7
10.1 9.2, 12.7.1
10.2 9.2, 12.7.1
10.3 9.2, 12.7.1
10.4 9.2, 12.7.1
10.5 9.2, 12.7.1
10.6 12.7.2, 12.7.3
11 11
11.8 12.5
12 7.1, 9.3
13.1 12.7.5
13.2 7.1, 9.3
13.3 7.2, 7.5, 9.1
13.3 (44.2) 8.1
13.3 (44.3) 7.6
13.3 (44.4) 7.6
13.3 (44.6) 7.6
13.3 (44.7) 1 8.1
13.4 9.2, 12.7.1
Table ZA.1 - Correspondence between this European Standard and EU Directives (continued)

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
13.5 9.2, 12.8
13.8 (49.2) 8.1
14.2 12.8.2
st
15 1 (1 paragraph), 2, 4
15 (53.2, 53.3) 5
15.1 4
15.2 9.2
16 1, 2, 3
16.1 7.3
16.3 9.1, 9.2
16.3 (56.5) 12.8.2
16.3 (56.8) 10.1, 10.2, 10.3, 12.8.2, 12.9
16.3 (56.11) 12.7.1
16.3 (56.12) 9.1, 12.7.4
16.4 9.1, 12.7.4, 12.6, 12.8.1
16.5 12.7.4
16.6 2, 3, 12.8.1, 12.9
16.6 (59.11) 10.1, 10.2, 10.3, 12.9
16.6 (59.11.2) 9.2, 9.3
16.6 (59.12) 7.2
st
59 7.5 (1 paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of Essential Health and Safety Qualifying remarks/Notes
this EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.1.4 This relevant EHSR is not addressed in
this European Standard
- 1.2.2 This relevant EHSR is not addressed in
this European standard; only partially
covered by EN 60601-1-6 and EN
- 1.5.4 This relevant EHSR is not fully
addressed in this European Standard:
only partially covered in EN 14971 and
EN 62366
- 1.6.1 This relevant EHSR is not addressed in
this European Standard
- 1.6.2 This relevant EHSR is not addressed in
this European Standard
- 1.6.3 This relevant EHSR is not addressed in
this European Standard
- 3.4.5 This relevant EHSR is not addressed in
this European Standard
- 3.6.2 This relevant EHSR is not addressed in
this European Standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 10079-1
Second edition
1999-08-15
Medical suction equipment —
Part 1:
Electrically powered suction equipment —
Safety requirements
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration — Prescriptions de sécurité
A
Reference number
ISO 10079-1:1999(E)
ISO 10079-1:1999(E)
Contents
1 Scope .1
2 Normative references .2
3 Terms and definitions .3
4 General requirements and general requirements for tests .5
5 Classification.5
6 Identification, marking and documents.5
7 Power input .7
8 Environmental conditions.7
9 Protection against electric shock hazards.8
10 Protection against mechanical hazards .9
11 Protection against hazards from unwanted or excessive radiation .10
12 Protection against hazards of ignition of flammable anaesthetic mixtures .10
13 Protection against excessive temperatures and other safety hazards .11
14 Accuracy of operating data and protection against hazardous output .15
15 Abnormal operation and fault conditions: environmental tests.15
16 Constructional requirements.17
Annexes A to L.25
Annex M (informative) Rationale statement.26
Annex N (informative) Table of typical ranges of volume for collection containers for specific uses.27
Annex O (informative) Lumen (passageway) size and its effects on flow.28
©  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.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 10079-1:1999(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 10079-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.
This second edition cancels and replaces the first edition (ISO 10079-1:1991), which has been technically revised.
ISO 10079 consists of the following parts, under the general title Medical suction equipment:

Part 1: Electrically powered suction equipment — Safety requirements
 Part 2: Manually powered suction equipment
 Part 3: Suction equipment powered from vacuum or pressure source
Annexes A to L of this part of ISO 10079 refer to Appendixes A to L of IEC 60601:1988, respectively. Annexes M, N
and O are for information only.
iii
INTERNATIONAL STANDARD  © ISO ISO 10079-1:1999(E)
Medical suction equipment —
Part 1:
Electrically powered suction equipment — Safety requirements
1 Scope
This part of ISO 10079 specifies minimum safety and performance requirements for medical and surgical suction
equipment (see Figure 1) for health care facilities such as hospitals, for domiciliary care of patients and for field and
transport use.
Although such equipment may be driven by centrally powered piped vacuum systems, compressed gases and
electricity, or be manually powered for a variety of applications, this part of ISO 10079 addresses only mains
electricity- and battery-powered suction equipment.
NOTE See also annex M in this part of ISO 10079.
ISO 10079-1 is one of a series of International Standards based on IEC 60601-1:1988; in IEC 60601-1 (the
"General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of
IEC 60601-1:1988, the requirements of this part of ISO 10079 take precedence over those of IEC 60601-1.
The scope and object given in clause 1 of IEC 60601-1:1988 apply, except that 1.1 shall be replaced by the
following:
This part of ISO 10079 is not applicable to:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings,
and wall connectors;
b) catheter tubes, drains, curettes and suction tips;
c) syringes;
d) dental suction equipment;
e) waste gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) passive urinary drainage;
i) closed systems for wound drainage;
j) gravity gastric drainage;
k) orally operated mucous extractors;
l) suction equipment where the collection container is downstream of the vacuum pump;
m) equipment marked as suction unit for permanent tracheostomy;
n) ventouse (obstetric) equipment;
o) neonatal mucous extractors;
p) suction equipment marked for endoscopic use only.
© ISO
ISO 10079-1:1999(E)
Key
1 Vacuum indicator
2 Filter
3 Collection container
4 Vacuum regulator
NOTE 1 This part of ISO 10079 applies to mains electricity- and battery-powered suction equipment. Part 2 of ISO 10079
applies to manually powered suction equipment. Part 3 of ISO 10079 applies to suction equipment powered from a vacuum or
pressure source.
NOTE 2 Components illustrated are not necessarily required by this part of ISO 10079.
NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements and
components not illustrated.
Figure 1 — Schematic drawing of suction equipment
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 10079. 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 10079 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 3744:1994, Acoustics — Determination of sound power levels of noise sources — Engineering methods for
free-field conditions over a reflecting plane.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
© ISO
ISO 10079-1:1999(E)
ISO 8836:1997, .
Suction catheters for use in the respiratory tract
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature.
IEC 60529:1976, Classification of degrees of protection provided by enclosures.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety; and Amd.1:1991 and
Amd.2:1995.
IEC 60651:1979, Sound level meters.
IEC 60695-2-2:1980, Fire hazard testing — Part 2: Test methods — Needle-flame test.
3 Terms and definitions
For the purposes of this part of ISO 10079, the terms and definitions given in clause 2 of IEC 60601-1:1988 apply
except that the definition given in 2.1.5 shall be replaced by the following:
2.1.5
applied part
all parts in the liquid pathway
Add to definition 2.4.3 the following:
2.4.3
safety extra-low voltage
SELV
electrical sources which are isolated (e.g. car battery) and do not require a separate transformer or converter
with separate windings
For the purposes of this part of ISO 10079, the following additional terms and definitions apply.
3.1
breast pump
vacuum pump for the collection of breast milk
3.2
collection container
container in which liquids and solid particles are collected
3.3
collection container assembly
collection container and its closure with connectors for suction
3.4
drainage
removal of fluids from a body cavity or wound
3.5
end-piece
that part of the suction equipment applied to the patient which begins at the site where material is drawn in and ends
at the first detachable connection
NOTE Examples of commonly used end-pieces are a Yanker sucker and a suction catheter.
3.6
exhaust opening
port or ports through which exhaust is discharged
© ISO
ISO 10079-1:1999(E)
-3.7
filter
device for retention of particulate matter
3.8
free air flow
unrestricted flow of air through a designated inlet
3.9
high flow suction
suction which produces a free air flow of 20 l/min or more
3.10
high vacuum
vacuum of 60 kPa or more below atmospheric pressure
NOTE 1 kPa = 7,50 mmHg or 4,02 inchH O or 10,2 cmH O or 10 hPa
2 2
3.11
inlet
port of a component through which fluids and/or solid particles enter
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent suction
type of suction in which the negative pressure applied to the end-piece is automatically and periodically returned to
atmospheric pressure
3.14
low flow suction
suction which produces a free air flow less than 20 l/min
3.15
low vacuum
vacuum of not more than 20 kPa below atmospheric pressure
3.16
medium vacuum
vacuum of more than 20 kPa but less than 60 kPa below atmospheric pressure
3.17
outlet
port of a component through which fluids and/or solid particles exit
3.18
overfill protection device
system intended to prevent liquid or solid particles from entering the intermediate tubing
3.19
suction
application of vacuum to remove fluids and/or solid particles
3.20
suction tubing
tubing for conduction of fluids and/or solid particles between the end-piece and the collection container
© ISO
ISO 10079-1:1999(E)
3.21
thoracic drainage
drainage by application of suction to the thoracic cavity of the patient
NOTE For the purposes of this part of ISO 10079, all thoracic drainage is considered to be active.
3.22
vacuum
pressure less than atmospheric pressure
NOTE In this part of ISO 10079, vacuum is expressed as a difference from atmospheric pressure.
3.23
vacuum indicator
device for displaying the level of vacuum
3.24
vacuum pump
powered device for generating vacuum
3.25
vacuum regulator
device for controlling the maximum vacuum applied to the patient
4 General requirements and general requirements for tests
The requirements given in clauses 3 and 4 of IEC 60601-1:1988 apply, together with the following additional item:
4.6 f) Where reference is made in test methods to tubing, the tubing which is supplied or recommended by the
manufacturer shall be used.
5 Classification
The classification given in clause 5 of IEC 60601-1:1988 applies.
6 Identification, marking and documents
The requirements given in clause 6 of IEC 60601-1:1988 apply, with the following additions and modifications:
6.1 e) add the following:
The address of the manufacturer, and the name and address of the supplier responsible within the region or
country if the supplier is not the manufacturer.
Wherever reasonable and practicable, the device and detachable components shall be identified, where
appropriate, in terms of batches, to allow the appropriate action to detect any potential risk posed by the
devices and detachable components.
6.1 f) add the following:
The equipment shall be marked with a batch or serial number and also year of manufacture, to allow all parts
in the functional state to be sufficiently identified to the level that appropriate action can be undertaken if a
defect or hazard arises.
Replace 6.1 p) by the following:
© ISO
ISO 10079-1:1999(E)
1) All equipment generating suction shall be marked with words indicating suction, and with an indication of
the available level of vacuum as determined by the manufacturer. This marking shall be visible in the
normal working position.
NOTE Equipment including vacuum should be marked with the designation; “high vacuum/high flow”, “high
vacuum/low flow”, “medium vacuum/high flow”, “medium vacuum/low flow”, “low vacuum/high flow” or “low
vacuum/low flow”, as appropriate.
2) Low vacuum equipment with a level of vacuum which is not adjustable by the user shall be marked either
with the level of vacuum which can be attained or with words indicating low vacuum.
3) Intermittent suction equipment shall be marked with words indicating intermittent suction. Equipment which
can provide both continuous and intermittent suction shall have the mode control clearly marked.
4) If there is a single exhaust opening, it shall be marked with words indicating exhaust opening.
5) Suction equipment intended for thoracic drainage and complying with 59.8 shall be marked as such.
6) The inlet connection to the collection container shall be identified unless misconnection is prevented by a
design feature.
7) If the suction equipment is intended for use in the field and/or transport and does not comply with 53.1, it
shall be marked on the equipment case as not suitable for use at temperatures below . °C or above . °C,
with the appropriate limiting temperatures marked. If no case is provided, the statement shall be marked
on the equipment.
In 6.1, add the following additional items:
aa)  Equipment containing a filter which is intended to be cleaned or changed by the user shall have wording
clearly marked on the equipment, or on the filter unit, to the effect that the filter should be cleaned or changed
in accordance with the manufacturer's recommendations.
ab)  The capacity of the collection container.
In 6.3 c), add the following:
If a progressive variation in the degree of vacuum is available, the direction of adjustment to increase vacuum
shall be clearly and permanently marked.
In 6.8.1, add the following:
The collection container capacity shall be stated in the accompanying documents.
In 6.8.2 a), add the following:
The instructions for use shall additionally include the following information:
1) instructions for operating the vacuum regulator, if supplied, and for setting the required vacuum;
2) the size and type of suction tubing recommended for use with the suction equipment and its means of
connection to the collection container;
3) recommended methods for cleaning and disinfection or sterilization of all applied parts;
4) the method for removing the collection container for emptying;
5) details of the operation of any overfill protection device fitted to the collection container assembly and the
usable capacity of the collection container in all the recommended inclined planes of operation;
6) if applicable, the method of controlling frothing in the collection container;
© ISO
ISO 10079-1:1999(E)
7) instructions, if applicable, for the replacement or cleaning of air filters, and for cleaning or sterilization of the
filter housing;
8) on performance as either
i) the type of equipment, e.g. medical suction, high vacuum, high flow,
ii) the level of vacuum and flow obtainable,
iii) the vacuum and air flow characteristics obtainable from the equipment as required by 6.1 p) 1), 2) or
3), as appropriate.
9) instructions to inspect suction tubing, collection containers and any other components that are subject to
wear or damage;
10) a statement advising removal and servicing of the equipment if liquid or solid has been drawn into the
vacuum pump;
NOTE In some cases, this may require servicing by the manufacturer or his authorized agent.
11) if applicable, a statement that suction ceases when the overfill protection device operates, and the method
of correcting this situation;
12) recommendations for cleaning and/or disinfection of the outer casing;
13) instructions for cleaning and sterilization or disinfection of reusable suction tubing;
14) instructions for sterilizing or disinfecting any part of a filter assembly which is reusable;
15) guidance for the intended use and limitations of the equipment, including whether or not the equipment is
intended for use within a health care facility, for domiciliary use, or for field and/or transport use.
7 Power input
The requirements given in clause 7 of IEC 60601-1:1988 apply.
8 Environmental conditions
8.1 Basic safety categories
Appendix A.1.2 of IEC 60601-1:1988 applies (see Amendment 2).
8.2 Removable protective means
Replaced by 6.1 z) of IEC 60601-1:1988.
8.3 Environmental conditions
The requirements given in clause 10 of IEC 60601-1:1988 apply, with the following modification.
Replace 10.2.1 a) with the following:
a) An ambient temperature range of + 5 °C to + 35 °C.
For field and/or transport use, environmental conditions shall be as specified in 4.10 and clause 10 of
IEC 60601-1:1988.
© ISO
ISO 10079-1:1999(E)
8.4 Special measures with respect to safety
Clauses 11 and 12 of IEC 60601-1:1988 are not used.
9 Protection against electric shock hazards
9.1 General
The requirements given in clause 13 of IEC 60601-1:1988 apply.
9.2 Requirements related to classification
The requirements given in clause 14 of IEC 6060l-1:1988 apply.
9.3 Limitation of voltage and/or energy
The requirements given in clause 15 of IEC 60601-1:1988 apply.
9.4 Enclosures and protective covers
The requirements given in clause 16 of IEC 60601-1: 1988 apply, together with the following additional item:
16 h) The housing shall be constructed of fire-retarding material which withstands the needle-flame test
specified in IEC 60695 2-2 when the flame is applied to any point on the inside or outside surface of the
housing for 20 s.
9.5 Separation
The requirements given in clause 17 of IEC 60601-1:1988 apply, except as follows:
Replace item 17 c) by the following:
For mains-powered equipment, accessible unearthed conductive parts shall not be connected to any part of
the applied part.
Compliance shall be checked by applying the normal operating voltage and frequency between any part of
the applied part and accessible unearthed conductive paths.
Leakage current shall not exceed 5 mA for Type B or BF equipment and 0,05 mA for Type CF equipment.
Measurements shall be made with the applied part filled with saline solution containing 9 g/l sodium chloride
until the overfill protection device operates or until saline solution emerges from the exhaust opening. For the
purposes of the test for Type B or BF equipment, an electrically isolated conductive cap on a collection
container is not considered to be part of the accessible unearthed conductive path.
9.6 Protective earthing, functional earthing and potential equalization
The requirements given in clause 18 of IEC 60601-1:1988 apply.
9.7 Continuous leakage currents and patient auxiliary currents
The requirements given in clause 19 of IEC 60601-1:1988 apply, together with the following addition:
In 19.4 h), add the following additional item:
12) Measurement shall be made with any overfill protection device operative. Fluid shall be drawn through a
suction catheter immersed in a container filled with saline solution containing 9 g/l sodium chloride, until
the overfill protection device operates or until saline solution emerges from the exhaust opening.
Measurement shall be made from the saline solution in the container.
© ISO
ISO 10079-1:1999(E)
9.8 Dielectric strength
The requirements given in clause 20 of IEC 60601-1:1988 apply.
10 Protection against mechanical hazards
10.1 Mechanical strength
The requirements given in clause 21 of IEC 60601-1:1988 apply, together with the following additional requirement:
Equipment intended for field and/or transport use shall meet the requirements for flow and vacuum of this part
of ISO 10079 after being dropped from a height of 1 m onto a concrete floor in the worst-case mode.
10.2 Moving parts
The requirements given in clause 22 of IEC 60601-1:1988 apply.
10.3 Surfaces, corners and edges
The requirements given in clause 23 of IEC 60601-1:1988 apply.
10.4 Stability in normal use
The requirements given in clause 24 of IEC 60601-1:1988 apply.
10.5 Expelled parts
The requirements given in clause 25 of IEC 60601-1:1988 apply.
10.6 Vibration and noise
The requirements given in clause 26 of IEC 60601-1:1988 shall be replaced by the following requirements:
26.1 Low vacuum equipment (see 59.7 and 59.8)
26.1.1 In normal use the maximum A-weighted sound pressure level (steady or peak value) of low
vacuum/low flow and low vacuum suction equipment including equipment for thoracic drainage shall not
exceed 60 dB.
Compliance shall be checked by the test given in 26.1.2.
26.1.2 Test the suction equipment with the inlet opened to the atmosphere and also with the inlet occluded.
Place the microphone of a sound level meter complying with the requirements for a type I instrument
specified in IEC 60651 at the position of maximum sound pressure level in the horizontal plane passing
through the geometric centre of the suction equipment at a radius of 1 m. The measured sound pressure
level shall not exceed the specified value.
For this test, the suction equipment shall be operated over its normal working range of flowrate including the
maximum flowrate recommended by the manufacturer. Measurements shall be taken using the frequency-
weighting characteristic A and the time-weighting characteristic S on the sound level meter. The
measurements shall be taken in a free field over a reflecting plane as specified in ISO 3744.
The A-weighted background level of extraneous noise shall be at least 10 dB below that measured during the
test.
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ISO 10079-1:1999(E)
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26.2 Equipment other than that specified in 26.1
In normal use, the maximum A-weighted sound pressure level (steady or peak value) of equipment other than
the low vacuum equipment specified in 26.1 shall not exceed 70 dB.
Compliance shall be checked by the test given in 26.1.2.
10.7 Pneumatic and hydraulic power
The requirements given in clause 27 of IEC 60601-1:1988 do not apply, as they are not relevant to suction
equipment.
10.8 Suspended masses
The requirements given in clause 28 of IEC 60601-1:1988 apply.
11 Protection against hazards from unwanted or excessive radiation
11.1 X-radiation
The requirements given in clause 29 of IEC 60601-1: 1988 apply.
11.2 Alpha, beta, gamma, neutron radiation and other particle radiation
The requirements given in clause 30 of IEC 60601-1:1988 apply.
11.3 Microwave radiation
The requirements given in clause 31 of IEC 60601-1:1988 apply.
11.4 Light radiation (including lasers)
The requirements given in clause 32 of IEC 60601-1:1988 apply.
11.5 Infra-red radiation
The requirements given in clause 33 of IEC 60601-1:1988 apply.
11.6 Ultraviolet radiation
The requirements given in clause 34 of IEC 60601-1:1988 apply.
11.7 Acoustical energy (including ultra-sonics)
The requirements given in clause 35 of IEC 60601-1:1988 apply.
11.8 Electromagnetic compatibility
The requirements given in clause 36 of IEC 60601-1:1988 apply.
12 Protection against hazards of ignition of flammable anaesthetic mixtures
12.1 Locations and basic requirements
The requirements given in clause 37 of IEC 60601-1:1988 apply.
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ISO 10079-1:1999(E)
12.2 Marking, accompanying documents
The requirements given in clause 38 of IEC 60601-1:1988 apply.
NOTE See also annex M in this part of ISO 10079.
12.3 Common requirements for Category AP and Category APG equipment
NOTE The abbreviations "AP" and "APG" stand for "anaesthetic-proof" and "anaesthetic-proof category G" respectively.
The requirements given in clause 39 of IEC 60601-1:1988 apply.
12.4 Requirements and tests for Category AP equipment, parts and components thereof
The requirements given in clause 40 of IEC 60601-1:1988 apply.
12.5 Requirements and tests for Category APG equipment, parts and components thereof
The requirements given in clause 41 of IEC 60601-1:1988 apply.
NOTE See also annex M in this part of ISO 10079.
13 Protection against excessive temperatures and other safety hazards
13.1 Excessive temperatures
The requirements given in clause 42 of IEC 60601-1:1988 apply.
13.2 Fire prevention
Clause 43 of IEC 60601-1:1988 applies, with the following addition:
In order to reduce the risk to patients, other persons or the surroundings due to fire, ignitable material, under
normal and single fault conditions, shall not at the same time be subjected to conditions in which the
temperature of the material is raised to its minimum ignition temperature; and an oxidant is present.
The minimum ignition temperature shall be determined in accordance with IEC 60079-4 using the oxidizing
conditions present under normal and single fault conditions.
Compliance shall be checked by determining the temperature to which the material is raised under normal
and single fault conditions.
If sparking can occur under normal or single fault conditions, the material subjected to the energy dissipation
of the spark shall not ignite under the oxidizing conditions present.
Compliance shall be checked by observing if ignition occurs under the most unfavorable combination of
normal conditions with a single fault.
13.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection
The requirements given in clause 44 of IEC 60601-1:1988 apply, with the following additions and modifications:
In 44.2, add the following:
Means shall be provided to prevent inadvertent contamination of the pump.
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ISO 10079-1:1999(E)
When the collection container is full, suction equipment shall either continue to operate and meet the
requirements of the relevant subclauses of clause 59 or shall have an overfill device to prevent liquids
entering the intermediate tubing downstream of the collection container.
If the suction equipment is fitted with an overfill device, suction shall cease when the overfill device operates
and not more than 5 ml of liquid shall pass downstream of the overfill device. If the overfill device is integral
with the collection container, it shall not activate until at least 90 % of the stated collection capacity has been
reached.
Compliance shall be checked by the following test.
Connect the overfill device according to the manufacturer's instructions. Set the suction equipment to
maximum free air flow and draw water at (23 ± 3) °C into the system until the overfill protection device is
activated. Run the equipment for a further 2 min. Measure the volume of water which has passed the overfill
device. If the overfill device is integral with the collection container, measure the volume collected in the
collection container.
Test suction equipment intended for reuse after 30 cycles of cleaning and disinfection or sterilization as
recommended by the manufacturer.
Replace by the following :
44.3
The suction equipment shall be so constructed that, in the event of spillage of liquids, no safety hazard shall
result.
Compliance shall be checked by the following test.
Place the suction equipment in the least favourable position of normal use and subject it for 30 s to an
artificial rainfall of 3 mm/min falling vertically from a height of 0,5 m above the top of the equipment.
Immediately after the 30 s exposure, remove visible moisture from the body of the equipment. The suction
equipment shall meet the relevant dielectric strength tests specified in 20.1 to 20.4 of IEC 60601-1:1988 and
meet the appropriate requirements for vacuum and flow specified in 16.6 of this part of ISO 10079.
Battery-operated transportable suction equipment intended for use in the field shall meet the requirements of
59.10 after exposure to water as specified in 8.3 of IEC 60529:1976 when in the carrying mode and position
as recommended by the manufacturer.
In 44.4, add the following:
1) Collection containers for general use
For collection containers intended for single use, the leakage of air into the collection container assembly
shall not exceed 200 ml/min, if the collection container is intended for suction with a free air flow of more than
1 l/min. The pressure increase shall be less than 3,3 kPa/V, where V is the volume in litres, of the collection
container.
A collection container assembly intended for reuse shall comply with the above requirement, before and after
being subjected to 30 cycles of cleaning and disinfection or sterilization as recommended by the
manufacturer.
Compliance shall be checked by the following test.
Evacuate the collection container to 40 kPa below atmospheric pressure. Close off the vacuum source, and
observe the pressure increase within 10 s. (See Figure 2 for a typical test apparatus.)
NOTE A typical collection container will have a pneumatic compliance of approximately 10 ml/kPa per litre volume.
A leakage of 200 ml/min corresponds to 33,3 ml per 10 s which would result in a pressure increase of
33,3/10 = 3,33 kPa per 10 s.
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ISO 10079-1:1999(E)
Key
1 Vacuum source
2 Vacuum regulator
3 Vacuum indicator accurate to 0,5 kPa between 30 kPa and 50 kPa below atmospheric pressure
4 On/off valve
5 Closed to atmosphere
6 Test collection container
Figure 2 — Typical test apparatus for evaluating leakage of collection container for general use
2) Collection containers intended for use in a thoracic drainage system.
The leakage of air into a collection container in a thoracic drainage system shall not exceed 4 ml/min. For
reusable collection containers, the test shall be applied before and after the container has been subjected to
30 cycles of cleaning and disinfection or sterilization as recommended by the manufacturer.
Compliance shall be checked by the following test.
Set the vacuum regulator to 15 kPa below atmospheric pressure. Open the valve and allow the container to
reach the set vacuum. Note the number of escaping bubbles escaping into the water bottle over a period of
10 s. (See Figure 3 for a typical test apparatus).
NOTE Three bubbles escaping in 10 s is approximately equivalent to a leakage of 4 ml/min.
In 44.6, add the following:
Remote foot switches with electrical switching parts shall be of watertight construction.
Compliance shall be checked by the following test.
Completely immerse the foot switch in water to a depth of 150 mm for a period of 30 min. While immersed,
connect the foot switch in a circuit corresponding to its normal use and actuat
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