Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)

EN ISO 10079-3 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The equipment can be stand-alone or part of an integrated system. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079. This part of ISO 10079 does not apply to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) end-piece such as suction catheters, Yankauer sucker and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; i) mucus extractors, including neonatal mucus extractors; j) ventouse (obstetric) equipment; k) breast pumps; l) liposuction; m) uterine aspiration; n) plume evacuation systems.

Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene Absauggeräte (ISO 10079-3:2014)

Dieser Teil von ISO 10079 legt Anforderungen für die Sicherheit einschließlich der Leistungsmerkmale von
vakuum- oder druckquellenbetriebenen medizinischen Absauggeräten fest (siehe Bild 1). Insbesondere gilt er
für Geräte, die an Rohrleitungen und Saugdüsen-Zubehör angeschlossen sind.
Die Geräte können eigenständige Geräte oder Teil eines integrierten Systems sein.
Es kann notwendig sein, dass Absauggeräte mit elektrisch gesteuerten Bauteilen, z. B. elektronische
Zeitsteuerungen, auch mit IEC 60601-1 übereinstimmen.
Dieser Teil von ISO 10079 gilt weder für elektrisch betriebene Absauggeräte, die, ob durch Netz oder Batterie
betrieben, in ISO 10079-1 behandelt werden, noch für handbetriebene Absauggeräte, die in ISO 10079-2
behandelt werden, noch für Folgendes:
a) zentrale Leistungsversorgung (durch Erzeugung von Vakuum/Druckluft), Rohrleitungssysteme von
Fahrzeugen und Gebäuden sowie Wandanschlüsse;
b) Katheterschläuche, Drains, Küretten und Absaugtüllen;
c) Spritzen;
d) zahnmedizinische Absauggeräte;
e) Abgas-Fortleitungssysteme;
f) Laborabsaugung;
g) Autotransfusionssysteme;
h) passive Harndrainage;
i) geschlossene Systeme für Wunddrainage;
j) Magendrainage mittels Schwerkraft;
k) mundbetriebene Schleimabsauger;
l) Absauggeräte mit Sammelbehälter unterhalb der Vakuumpumpe;
m) als Absaugeeinheit für Dauertracheotomie gekennzeichnete Geräte;
n) Sauggeräte für Geburtshilfe;
o) Schleimabsauger für Neugeborene;
p) Milchpumpen;
q) Fettabsaugung;
r) Absaugung aus dem Uterus.

Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression (ISO 10079-3:2014)

L'ISO 10079-3:2013 spécifie les exigences de sécurité et de performance relatives aux appareils d'aspiration médicale alimentés par une source de vide ou de gaz à pression positive générant une aspiration Venturi. Elle est applicable aux appareils raccordés à des bouteilles ou des systèmes de distribution de gaz médicaux et aux systèmes venturi.
L'appareil peut être autonome ou faire partie d'un système intégré.

Medicinska sukcijska (aspiracijska) oprema - 3. del: Podtlačna ali tlačna sukcijska (aspiracijska) oprema (ISO 10079-3:2014)

EN ISO 10079-3 določa zahteve glede varnosti in učinkovitosti za medicinsko podtlačno ali tlačno sukcijsko (aspiracijsko) opremo. Velja za opremo, ki je povezana s sistemi napeljav za medicinske pline ali jeklenkami in priključki venturijeve cevi. Priloga D s shematskim prikazom tipičnih sistemov prikazuje tri dele ISO 10079. Oprema je lahko samostojen sistem ali del integriranega sistema. Dodatne zahteve za sukcijsko (aspiracijsko) opremo, ki je namenjena uporabi na prostem in/ali med prevozom, so vključene v ta del standarda ISO 10079. Ta del standarda ISO 10079 ne velja za naslednje: a) centralno oskrbo z električno energijo (ustvarjeno z vakuumom ali stisnjenim zrakom), cevne sisteme vozil in stavb ter stenske priključke; b) zaključke, kot so aspiracijski katetri, aspiracijske cevke Yankauer in konice za sukcijo; c) injekcijske brizge; d) opremo za zobno sukcijo; e) sisteme za odstranjevanje anestezijskih plinov in hlapov; f) laboratorijsko sukcijo; g) sisteme za avtotransfuzijo; h) zaprte sisteme za drenažo rane; i) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke; j) opremo za vakuumsko ekstrakcijo (porodna oprema); k) prsne črpalke; l) liposukcijo; m) endometrijsko aspiracijo; n) sisteme za odvod dima.

General Information

Status
Withdrawn
Public Enquiry End Date
19-Jun-2012
Publication Date
05-Jun-2014
Withdrawal Date
20-Jun-2022
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
21-Jun-2022
Due Date
14-Jul-2022
Completion Date
21-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 10079-3:2014
01-julij-2014
1DGRPHãþD
SIST EN ISO 10079-2:2009
SIST EN ISO 10079-3:2009

0HGLFLQVNDVXNFLMVND DVSLUDFLMVND RSUHPDGHO3RGWODþQDDOLWODþQDVXNFLMVND

DVSLUDFLMVND RSUHPD ,62
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or
positive pressure gas source (ISO 10079-3:2014)
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene
Absauggeräte (ISO 10079-3:2014)

Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une

source de vide ou de pression (ISO 10079-3:2014)
Ta slovenski standard je istoveten z: EN ISO 10079-3:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-3:2014 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10079-3:2014
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SIST EN ISO 10079-3:2014
EUROPEAN STANDARD
EN ISO 10079-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2014
ICS 11.040.10 Supersedes EN ISO 10079-3:2009
English Version
Medical suction equipment - Part 3: Suction equipment powered
from a vacuum or positive pressure gas source (ISO 10079-
3:2014)

Appareils d'aspiration médicale - Partie 3: Appareils Medizinische Absauggeräte - Teil 3: Vakuum- oder

d'aspiration alimentés par une source de vide ou de druckquellenbetriebene Absauggeräte (ISO 10079-3:2014)

pression (ISO 10079-3:2014)
This European Standard was approved by CEN on 15 February 2014.

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-CENELEC 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-CENELEC Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-3:2014 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10079-3:2014
EN ISO 10079-3:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC .........................................................................................................4

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SIST EN ISO 10079-3:2014
EN ISO 10079-3:2014 (E)
Foreword

This document (EN ISO 10079-3:2014) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic

and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and

anaesthetic equipment” the secretariat of which is held by DIN.

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 November 2014, and conflicting national standards shall be withdrawn

at the latest by May 2017.

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 10079-3:2009.

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 EU Directive.

For relationship with EU Directive, 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, Croatia, Cyprus, Czech

Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 10079-3:2014 has been approved by CEN as EN ISO 10079-3:2014 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 10079-3:2014
EN ISO 10079-3:2014 (E)
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

Directive 93/42/EEC.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the normative 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 relevant Essential Requirements of that Directive.

NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Essential
Clause(s) / sub-
Requirements (ERs) of Qualifying remarks/notes
clause(s) of this EN
Directive 93/42/EEC
4.1, 4.4, 12 t) 7.1 Partly covered
There are no requirements for materials apart from a
requirement to perform a risk assessment and to
disclose the presence of latex.
As these devices are only for extracting body fluids
toxicity and biological compatibility is not considered
a risk.
4.1, 5, 7.5, 7.5.2, 7.7 7.2
4.1, 4.2, 5 7.3 Only the first part of this ER is covered
7.5.1, 7.5.2 8.1
4.1, 6.3, 6.5 9.1
4.1, 10 9.2 Only covered as far as temperature is concerned
7.4 12.7.1 Only covered as far as stability is concerned
7.6 12.7.3
6.5 12.7.4
11, 12 13.1
11.2 a) 13.3 a)
11.2 b) 13.3 b)
11.2 c) 13.3 c)
11.2 d) 13.3 d)
11.2 e) 13.3 e)
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SIST EN ISO 10079-3:2014
EN ISO 10079-3:2014 (E)
11.2 f) 13.3 f)
12 b) 13.4 Partly covered: disclosure of the intended purpose is
included in the Instructions for use but not the
labelling.
12 13.6a) Covered for the items in 13.3 a), b), c), f), i) and k)
12 b), c), d), f),g), h), j), 13.6 b)
k), o), t), u)
12 k) 13.6 c)
12 b), c), d), h), j), v) 13.6 d)
12 i) 13.6 h) First two paragraphs only
12 d) 13.6 i)
12 z) 13.6 q)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
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SIST EN ISO 10079-3:2014
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SIST EN ISO 10079-3:2014
INTERNATIONAL ISO
STANDARD 10079-3
Third edition
2014-05-01
Medical suction equipment —
Part 3:
Suction equipment powered from
a vacuum or positive pressure gas
source
Appareils d’aspiration médicale —
Partie 3: Appareils d’aspiration alimentés par une source de vide ou
de pression
Reference number
ISO 10079-3:2014(E)
ISO 2014
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SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 General requirements ..................................................................................................................................................................................... 4

4.1 Risk management ................................................................................................................................................................................. 4

4.2 Usability ........................................................................................................................................................................................................ 5

4.3 Clinical investigation .......................................................................................................................................................................... 5

4.4 Biophysical or modelling research ........................................................................................................................................ 6

5 Cleaning, disinfection and sterilization ........................................................................................................................................ 6

6 Design requirements ........................................................................................................................................................................................ 6

6.1 Collection container............................................................................................................................................................................ 6

6.2 Connections ............................................................................................................................................................................................... 7

6.3 Suction tubing .......................................................................................................................................................................................... 7

6.4 Vacuum level indicators .................................................................................................................................................................. 7

6.5 Supply connections ............................................................................................................................................................................. 8

7 Operational requirements ......................................................................................................................................................................... 8

7.1 Ease of operation .................................................................................................................................................................................. 8

7.2 Dismantling and reassembly ....................................................................................................................................................... 8

7.3 Mechanical shock .................................................................................................................................................................................. 8

7.4 Stability .......................................................................................................................................................................................................... 9

7.5 Protective devices ................................................................................................................................................................................. 9

7.6 Noise ................................................................................................................................................................................................................ 9

7.7 Air leakage ...............................................................................................................................................................................................10

8 Physical requirements for field and transport use suction equipment ...................................................10

8.1 (*)Dimensions .....................................................................................................................................................................................10

8.2 Mass ...............................................................................................................................................................................................................10

9 Performance requirements for vacuum level and flowrate .................................................................................11

9.1 High vacuum/high flowrate equipment .........................................................................................................................11

9.2 Medium vacuum equipment.....................................................................................................................................................11

9.3 Low vacuum/low flowrate equipment ............................................................................................................................11

9.4 Low vacuum/high flowrate equipment ..........................................................................................................................11

9.5 Thoracic drainage equipment for adults .......................................................................................................................11

9.6 Intermittent vacuum equipment ..........................................................................................................................................12

9.7 Vacuum regulators with fixed setting ..............................................................................................................................12

9.8 Vacuum regulators with variable setting ......................................................................................................................12

9.9 Equipment intended for pharyngeal suction .............................................................................................................12

10 (*)Resistance to environment of suction equipment for field and/or transport use ...............12

10.1 Operating conditions ......................................................................................................................................................................12

10.2 Storage ........................................................................................................................................................................................................12

11 Marking .......................................................................................................................................................................................................................12

11.1 Use of symbols ......................................................................................................................................................................................12

11.2 Equipment ................................................................................................................................................................................................13

11.3 Equipment or carrying case ......................................................................................................................................................14

12 Information to be supplied by the manufacturer ............................................................................................................14

Annex A (normative) Test methods ....................................................................................................................................................................16

Annex B (informative) Rationale statement ..............................................................................................................................................27

Annex C (informative) Lumen size and its effect on flowrate ..................................................................................................28

© ISO 2014 – All rights reserved iii
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SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)

Annex D (informative) Schematic of suction equipment ..............................................................................................................29

Bibliography .............................................................................................................................................................................................................................30

iv © ISO 2014 – All rights reserved
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SIST EN ISO 10079-3:2014
ISO 10079-3:2014(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers

to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 8, Suction devices for hospital and emergency care use.

This third edition cancels and replaces the second edition (ISO 10079-3:1999), 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
— Part 2: Manually powered suction equipment

— Part 3: Suction equipment powered from a vacuum or positive pressure gas source

Annex A forms a normative part of this part of ISO 10079 while Annexes B, C and D are for information

only.

Annex B contains rationale statements for some of the requirements of this part of ISO 10079. The clauses

and subclauses marked with an asterisk (*) after their number have corresponding rationale contained

in Annex B, included to provide additional insight into the reasoning that led to the requirements and

recommendations that have been incorporated in this part of ISO 10079. It is considered that knowledge

of the reasons for the requirements will not only facilitate the proper application of this part of ISO 10079,

but will expedite any subsequent revisions.
© ISO 2014 – All rights reserved v
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SIST EN ISO 10079-3:2014
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SIST EN ISO 10079-3:2014
INTERNATIONAL STANDARD ISO 10079-3:2014(E)
Medical suction equipment —
Part 3:
Suction equipment powered from a vacuum or positive
pressure gas source
1 Scope

This part of ISO 10079 specifies safety and performance requirements for medical suction equipment

powered from a vacuum or positive pressure gas source generating venturi suction. It applies to

equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D

illustrates the three parts of ISO 10079 by providing a schematic for typical systems.

The equipment can be stand-alone or part of an integrated system.

Additional requirements for suction equipment intended for field and/or transport use are included in

this part of ISO 10079.
This part of ISO 10079 does not apply to the following:

a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and

buildings, and wall connectors;
b) end-piece such as suction catheters, Yankauer sucker and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) closed systems for wound drainage;
i) mucus extractors, including neonatal mucus extractors;
j) ventouse (obstetric) equipment;
k) breast pumps;
l) liposuction;
m) uterine aspiration;
n) plume evacuation systems.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

© ISO 2014 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)

ISO 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using

sound pressure — Engineering methods for an essentially free field over a reflecting plane

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5359, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases

ISO 7000 , Graphical symbols for use on equipment — Registered symbols

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications

IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for safety

IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential

performance—Collateral standard: Usability
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications

IEC 62366, Medical devices — Application of usability engineering to medical devices

EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
collection container
container in which liquids and solid particles are collected
3.2
collection container assembly
collection container and its closure with connectors for suction
3.3
drainage
removal of liquid, solid particles or gas from body cavity or wound
3.4
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 1 to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.

3.5
exhaust port
opening through which exhaust gas is discharged

1) The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available on the Online Browsing

Platform http://www.iso.org/obp.
2 © ISO 2014 – All rights reserved
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SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)
3.6
field use

use of suction equipment in situations outside of the health care facility at the site of accidents or other

emergencies
3.7
filter
device for retention of particulate matter
3.8
free air flowrate
rate of unrestricted flow of air through a designated inlet
3.9
high flowrate
free air flowrate of 20 l/min or more
3.10
high vacuum
vacuum level of 60 kPa or more below atmospheric pressure
3.11
inlet port
opening through which liquids, solid particles or gas enter
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum

type of suction in which the negative pressure applied to the end piece is automatically and periodically

returned to atmospheric pressure
3.14
low flowrate
free air flowrate less than 20 l/min
3.15
low vacuum
vacuum level of not more than 20 kPa below atmospheric pressure
3.16
medical gas pipeline system

complete system which comprises a supply system, a monitoring and alarm system and a distribution

system with terminal units at the points where medical gases or vacuum are required

[SOURCE: ISO 7396-1:2007, definition 3.29]
3.17
medium vacuum
vacuum level of more than 20 kPa but less than 60 kPa below atmospheric pressure
3.18
outlet port
opening through which gas exits from the collection container
3.19
overfill protection device

device intended to prevent liquid or solid particles from entering the intermediate tubing

© ISO 2014 – All rights reserved 3
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SIST EN ISO 10079-3:2014
ISO 10079-3:2014(E)
3.20
single fault condition

condition in which a single means for protection against a safety hazard in equipment is defective or a

single external abnormal condition is present
Note 1 to entry: Maintenance of equipment is considered a normal condition.
3.21
suction
application of vacuum to remove liquid, solid particles or gas
3.22
suction tubing

tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container

3.23
thoracic drainage

drainage of liquids and gas from the thoracic cavity by application of suction to the thoracic cavity of

the patient

Note 1 to entry: For the purposes of this part of ISO 10079, all thoracic drainage is considered to be active.

3.24
transport use

use during patient transport outside of a health care facility (e.g. in an ambulance or airplane)

3.25
vacuum level
pressure less than atmospheric pressure

Note 1 to entry: In this part of ISO 10079, vacuum level is expressed as a difference from atmospheric pressure.

3.26
vacuum level indicator
device for displaying the vacuum level
3.27
vacuum source
component of device for generating vacuum
3.28
vacuum regulator
device for controlling the applied vacuum level
4 General requirements

Suction equipment with components controlled by electrical means, e.g. electronic timing, shall meet

the relevant requirements of IEC 60601-1:2005+A1:2012.
4.1 Risk management

4.1.1 This part of ISO 10079 specifies requirements that are generally applicable to risks associated

with suction equipment powered from a vacuum or positive gas source. An established risk management

process shall be applied to the design of the device. The risk management process shall include the

following elements:
— risk
...

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