EN ISO 10079-2:1999

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction to establish and maintain the patency of the airway. It covers equipment operated by foot or by hand or both (.). Non-electrical suction equipment which may be integrated with electrical equipment is within the scope of this part.  This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity or battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure source which is dealt with in ISO 10079-3, nor the following:  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) breast pumps; q) liposuction; r) uterine aspiration; s) thoracic drainage.

Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:1999)

Dieser Teil von ISO 10079 legt Anforderungen an die Sicherheit und Leistung von handbetriebenen medizinischen Absauggeräten für oro-pharyngeale Absaugung fest. Er umfaßt von Fuß oder Hand oder von beidem betriebene Geräte (siehe Bild 1). Nichtelektrische Absauggeräte, die in elektrische Geräte eingebaut sein können, sind im Anwendungsbereich dieses Teils enthalten.

Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-2:1999)

Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:1999)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-1999
• Withdrawal Date: 03-Mar-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Mar-2009
• Completion Date: 04-Mar-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10079-2:2000 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

Relations

• Replaced By: EN ISO 10079-2:2009 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
• Effective Date: 11-Mar-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-2:2000
01-januar-2000
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO5RþQDVXNFLMVNDDVSLUDFLMVND
RSUHPD,62
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-
2:1999)
Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:1999)
Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-
2:1999)
Ta slovenski standard je istoveten z: EN ISO 10079-2:1999
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 10079-2
Second edition
1999-08-15
Medical suction equipment —
Part 2:
Manually powered suction equipment
Appareils d'aspiration médicale —
Partie 2: Appareils d'aspiration manuelle
A
Reference number
ISO 10079-2:1999(E)

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ISO 10079-2:1999(E)
Contents
1 Scope .1
2 Normative references .2
3 Terms and definitions .3
4 Cleaning and sterilization .3
5 Design requirements .3
6 Operational requirements .4
7 Physical requirements.5
8 Performance requirements for vacuum and flowrate .6
9 Resistance to environment.6
10 Marking .7
11 Information to be supplied by manufacturer .7
Annex A (normative) Test methods.8
Annex B (informative) Table of typical ranges of volume for collection containers for specific uses.12
Annex C (informative) Rationale statement.13
©  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 [e-mail]
Printed in Switzerland
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© ISO
ISO 10079-2:1999(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
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 10079-2 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 10079-2:1992), 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
Annex A forms a normative part of this part of ISO 10079. Annexes B and C are for information only.
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INTERNATIONAL STANDARD  © ISO ISO 10079-2:1999(E)
Medical suction equipment —
Part 2:
Manually powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction
equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see
Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the
scope of this part of ISO 10079.
This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity- or
battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure
source which is dealt with in ISO 10079-3, nor to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and
wall connectors;
b) cathether 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) breast pumps;
q) liposuction;
r) uterine aspiration;
s) thoracic drainage.
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© ISO
ISO 10079-2:1999(E)
Key
1 Vacuum indicator
2 Filter
3 Collection container
4 Vacuum regulator
NOTE 1 ISO 10079-1 applies to mains electricity- and battery-powered suction equipment. ISO 10079-2 applies to manually
powered suction equipment. ISO 10079-3 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 which are not illustrated.
Figure 1 — Examples 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 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 8836:1997, Suction catheters for use in the respiratory tract.
ISO 10079-1:1999, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety
requirements.
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© ISO
ISO 10079-2:1999(E)
3 Terms and definitions
For the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 and the following apply.
3.1
manually powered vacuum
manually generated vacuum
generation of vacuum by human effort with a hand or foot or both
3.2
transportable equipment
equipment which is intended to be easily moved from one place to another, whether or not connected to the vacuum
supply, without an appreciable restriction of range
4 Cleaning and sterilization
The suction equipment shall meet the requirements given in 8.1 to 8.3 after those components which are
4.1
subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning,
disinfection and/or sterilization as recommended by the manufacturer.
4.2  Any filters installed shall either be of the disposable type or be capable of being cleaned, disinfected and/or
sterilized for re-use in accordance with 4.1.
4.3  Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements
given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30
cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
4.4  Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as
recommended by the manufacturer.
5 Design requirements
NOTE The constructional requirements may deviate from those detailed in this part of ISO 10079 if the equivalent level of
safety is obtained.
5.1 Connectors
5.1.1 Collection container connectors
The connectors for the suction tubing and the intermediate tubing to the vacuum source shall be designed to
facilitate correct assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be
checked by inspection.
The construction of the connections has frequently been a source of spillover into a vacuum pump. The use of
mechanical fittings so as to ensure correct attachment is highly desirable.
5.1.2 Inside diameter of suction tubing connection
The inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameter
of the largest tubing size recommended by the manufacturer.
5.1.3 Exhaust opening
It shall not be possible to connect suction tubing to the exhaust opening.
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© ISO
ISO 10079-2:1999(E)
5.2 Suction tubing
5.2.1 General
If supplied, suction tubing shall have an inside diameter of not less than 6 mm.
Suction performance may be markedly affected by the length, diameter and degree of collapse of the suction tubing.
When tested in accordance with A.2, the degree of collapse of the suction tubing supplied with the equipment shall
be less than 0,5 throughout its entire length.
5.2.2 Length of suction tubing for foot-operated suction equipment
When the foot-operated vacuum pump is on the floor in the operating position, the length of suction tubing, if
supplied, shall be such that the endpiece can be positioned at least 1,3 m above the floor.
NOTE See also annex C for rationale.
5.3 End-pieces
Suction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836.
6 Operational requirements
6.1 Ease of operation
The suction equipment shall be designed to be operated by one person unaided.
6.2 Dismantling and reassembly
Suction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed to facilitate
correct assembly or marked to indicate correct reassembly when all parts are mated. After dismantling, reassembly
and testing in accordance with the manufacturer's instructions, the suction equipment shall meet the requirements
given in 8.1 to 8.3, as appropriate.
6.3 Mechanical shock
After suction equipment intended for field or transport use or both has been drop-tested in accordance with A.3, it
shall meet the requirements given in 8.1 to 8.3, as appropriate.
Field use of suction equipment is intended to cover use in situations outside the health care facility at the site of
accidents or other emergencies. The use of suction equipment in these situations may expose the equipment to
water (including rain), dirt, uneven support, mechanical shock and extremes of temperature.
Transport use of suction equipment is intended to cover situations outside the health care facility such as in
ambulances, cars or airplanes. Use of suction equipment in these situations may expose the equipment to uneven
support, dirt, mechanical shock and a wider range of temperature than normally found in health care facilities.
If the suction equipment can be operated outside its carrying case, it shall meet the requirements given in 8.1 to 8.3,
as appropriate, after the individual parts of the suction equipment have been drop-tested in accordance with A.3 and
reassembled.
6.4 Immersion in water
After suction equipment intended for field use has been dropped in its ready-for-use condition from a height of 1 m
into a water reservoir 1 m ´ 1 m ´ 1 m, has been left in the water for 10 s and the water has been expelled for 7 s,
it shall meet the requirements given in 8.1 to 8.3, as appropriate.
NOTE Equipment for field use is likely to experience extreme outdoor conditions and should therefore be designed to
withstand immersion in water and continue to perform satisfactorily.
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© ISO
ISO 10079-2:1999(E)
6.5 Stability
Suction equipment operated by foot and intended for field or transport use, or both, shall meet the requirements
given in 8.1 to 8.3, as appropriate, when placed on a surface of 20° (0,35 rad) slope from the horizontal. Other
manually powered suction equipment when operated 10° (0,17 rad) from its normal orientation shall meet the
requirements given in 8.1 to 8.3, as appropriate, in any position except that excluded by the manufacturer as
specified in 11 b).
6.6 Overfill protection devices
6.6.1  For equipment with means to prevent liquids or solids entering the intermediate tubing, the collection
container shall collect not less than 90 % of the stated collection capacity when tested in accordance with A.4.
NOTE Some equipment is designed to continue to pumping when the collection container is full.
6.6.2  Suction shall cease when the overfill protection device operates.
6.7 Vacuum Indicators
6.7.1  Analog displays shall have graduations not less than 2 mm apart, each graduation representing not more
than 5 % of the full-scale value.
6.7.2  Digital displays shall display vacuum at intervals of not greater than 2 % of the full-scale value. The
maximum vacuum for which the equipment is designed shall be marked prominently on the display case or
immediately adjacent to it.
6.7.3  All markings on the vacuum indicator shall be legible to an operator having visual acuity, corrected if
necessary, of at least 1,0, seated or standing 1 m from the vacuum indicator at an illuminance of 215 lx using white
(simulated day-) light.
6.7.4  The full scale of analog vacuum indicators shall be not more than 200 % of the maximum designed negative
pressure of the suction equipment.
6.7.5  Vacuum indicators shall be accurate to within ± 5 % of the full-scale value.
NOTE Movement of a rotary analog vacuum indicator should be anticlockwise for an increase in vacuum.
7 Physical requirements
7.1 Dimensions
Suction equipment intended for field use, including any carrying case or frame, shall pass through a rectangular
opening having dimensions of 600 mm ´ 300 mm.
NOTE 1 Suction equipment is often combined with resuscitation equipment which may make it impossible to define the mass
or dimensions for suction equipment alone. In these circums
...