SIST EN ISO 10079-1:2016

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)

This part of ISO 10079 specifies safety and performance requirements for electrically powered medical
and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals,
for domiciliary care of patients and for field and transport use.
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-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) plume evacuation systems.

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-1:2015)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-1:2015)

ISO 10079-1:2015 spécifie les exigences de sécurité et de performance pour les appareils électriques d'aspiration médicale et chirurgicale. Elle s'applique aux appareils utilisés dans les établissements de soins tels que les hôpitaux, pour les soins des patients à domicile, ainsi que pour une utilisation sur le terrain et lors d'un transport.
ISO 10079-1:2015 ne s'applique pas aux éléments énumérés ci-après:
a) les alimentations motrices à partir d'une centrale (air comprimé/aspiration), les systèmes de canalisations des véhicules et bâtiments, ainsi que les raccords muraux;
b) les pièces d'extrémité, telles que les sondes d'aspiration, les drains, les curettes, les « Yankauer » et les embouts d'aspiration;
c) les seringues;
d) les appareils dentaires d'aspiration;
e) les systèmes d'évacuation des gaz d'anesthésie;
f) l'aspiration en laboratoire;
g) les systèmes d'autotransfusion;
h) les extracteurs de mucosités, y compris ceux pour nouveau-nés;
i) les appareils d'aspiration dont le bocal de recueil est en aval de la pompe à vide;
j) les appareils avec ventouse (obstétrique);
k) les appareils d'aspiration à usage endoscopique uniquement (marqués comme tels);
l) les systèmes d'évacuation de fumée.

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema (ISO 10079-1:2015)

Ta del standarda ISO 10079 določa varnostne in tehnične zahteve za električno medicinsko
in kirurško sukcijsko (aspiracijsko) opremo. Velja za opremo, ki se uporablja v zdravstvenih ustanovah, kot so bolnišnice,
za oskrbo pacientov na domu ter za uporabo na terenu in med transportom.
Ta del standarda ISO 10079 se ne uporablja 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) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke;
i) sukcijsko opremo, pri kateri je zbiralni zabojnik priključen za vakuumsko črpalko;
j) opremo za vakuumsko ekstrakcijo (porodna oprema);
k) sukcijsko opremo, ki je namenjena izključno endoskopiji;
n) sisteme za odvod dima.

General Information

• Status: Published
• Public Enquiry End Date: 14-Apr-2014
• Publication Date: 10-Jan-2016
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Dec-2015
• Due Date: 12-Feb-2016
• Completion Date: 11-Jan-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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: EN ISO 10079-1:2015 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)

Relations

• Replaced By: SIST EN ISO 10079-1:2022 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
• Effective Date: 06-Apr-2022
• Amended By: SIST EN ISO 10079-1:2016/A1:2019 - Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 10079-1:2009 - Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
• Effective Date: 01-Feb-2016
• Amended By: SIST EN ISO 10079-1:2016/A1:2019 - Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)
• Effective Date: 01-Apr-2019
• Replaces: SIST EN ISO 10079-1:2009 - Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-1:2016
01-februar-2016
1DGRPHãþD
SIST EN ISO 10079-1:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO(OHNWULþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD,62
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-
1:2015)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-
1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-
1:2015)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2015
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-1:2016

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SIST EN ISO 10079-1:2016


EN ISO 10079-1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2015
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-1:2009
English Version

Medical suction equipment - Part 1: Electrically powered
suction equipment (ISO 10079-1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration (ISO 10079-1:2015) betriebene Absauggeräte (ISO 10079-1:2015)
This European Standard was approved by CEN on 13 May 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2015 E
worldwide for CEN national Members.

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SIST EN ISO 10079-1:2016
EN ISO 10079-1:2015 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4

2

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SIST EN ISO 10079-1:2016
EN ISO 10079-1:2015 (E)
European foreword
This document (EN ISO 10079-1:2015) 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 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 May 2016, and conflicting national standards shall be
withdrawn at the latest by November 2018.
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 10079-1:2009.
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(s).
For relationship with EU Directive(s), 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 10079-1:2015 has been approved by CEN as EN ISO 10079-1:2015 without any
modification.
3

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SIST EN ISO 10079-1:2016
EN ISO 10079-1:2015 (E)
Annex ZA
(informative)

Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/023
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 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 Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
7.1 4.4
Third indent only
7.2 5; 7.5 Partly covered
There are no requirements for
packaging.
7.3 6.1.3
First part only
7.6 6.2.3; 6.5; 7.5.1; 7.5.2
8.1 4.2; 5; 7.5.1
8.7 11.3 c)
9.1 6.2; 6.3
First sentence only
9.2 4; 6.1.3 Partly covered
Electrical safety is by ref to
IEC 60601–1 and risk management
by ref to ISO 14971.
4

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SIST EN ISO 10079-1:2016
EN ISO 10079-1:2015 (E)
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
10.1 6.4.6 Partly covered.
There are no requirements for the
manufacturer to disclose the
accuracy of the vacuum level
indicator.
10.2 6.4
10.3 11.3 i) Covered for volume measurements
only
12.1 4 Covered by ref to IEC 60601–1
12.1a) 4 Covered by ref to IEC 60601–1
12.2 4 Covered by ref to IEC 60601–1
although suction equipment is not
considered life-support equipment.
12.5 4 Covered by ref to IEC 60601–1 and
thereby to IEC 60601–1–2
12.6 4; 6.5 Covered by ref to IEC 60601–1
12.7.1 6.1.3; 7.4
12.7.2 4 Covered by ref to IEC 60601–1
12.7.3 7.6
12.7.4 4 Covered by ref to IEC 60601–1
12.7.5 4 Covered by ref to IEC 60601–1
12.8.2 7.5.3.2
Second sentence only
12.9 11.3 i); j); k); l); m); n); o); p); q); r)
13.1 11
13.2 11.2
13.3a) 11.3 a)
13.3b) 11.3 b)
13.3c) 11.3 c)
13.3d) 11.3 d)
13.3e) 11.3 e)
13.3 f) 11.3 f)
13.3 k) 11.4 c); q); y)
13.3 l) 11.3 d)
13.3 m) 11.4 i)
13.4 11.4 b)
13.6 a) 11.4 Not covered for the requirement of
ER 13.3b)
13.6 b) 11.4 d); e)
5

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SIST EN ISO 10079-1:2016
EN ISO 10079-1:2015 (E)
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
13.6 c) 11.4 d) ;k)
13.6 d) 11.4 d); j); v) Calibration is not covered
13.6 f) 11.4 x)
13.6 h) 11.4 i)
First two paragraphs only
13.6 i) 11.4 j)
13.6 q) 11.4 z)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
6

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SIST EN ISO 10079-1:2016
INTERNATIONAL ISO
STANDARD 10079-1
Third edition
2015-11-01
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d’aspiration médicale —
Partie 1: Appareils électriques d’aspiration
Reference number
ISO 10079-1:2015(E)
©
ISO 2015

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SIST EN ISO 10079-1:2016
ISO 10079-1:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 10079-1:2016
ISO 10079-1:2015(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 . 5
4.5 Test methods . 5
5 Cleaning, disinfection and sterilization . 5
6 Design requirements . 6
6.1 Collection container. 6
6.1.1 General. 6
6.1.2 Container capacity . 6
6.1.3 Container strength . 6
6.2 Connections . 6
6.2.1 Tubing connectors for collection containers . 6
6.2.2 Inlet port . 7
6.2.3 Exhaust port. 7
6.3 Suction tubing . 7
6.4 Vacuum level indicators . 7
6.5 Spillage on electrical suction equipment . 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 . 8
7.5 Protective devices . 9
7.5.1 Contamination protection . 9
7.5.2 Overfill protection devices . 9
7.5.3 Pressure protection . 9
7.6 Noise . 9
7.6.1 Low vacuum/low flowrate equipment . 9
7.6.2 Suction equipment other than that specified in 7.6.1 . 9
7.7 Air leakage .10
7.7.1 Collection containers for general use .10
7.7.2 Collection containers for thoracic drainage .10
8 Physical requirements for suction equipment for field use .10
8.1 (*) Dimensions .10
8.2 Mass .10
9 Performance requirements for vacuum level and flowrate .10
9.1 High vacuum/high flowrate equipment .10
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 .11
9.7 Vacuum regulators with fixed setting .11
9.8 Vacuum regulators with variable setting .12
9.9 Equipment intended for pharyngeal suction .12
© ISO 2015 – All rights reserved iii

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SIST EN ISO 10079-1:2016
ISO 10079-1:2015(E)

9.10 Battery powered transportable suction equipment .12
9.11 Interruption of the power supply .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 Information to be supplied by the manufacturer (labelling and instructions for use) .13
11.1 Information supplied by the manufacturer shall comply with EN 1041. .13
11.3 Labelling of equipment .13
11.4 Instructions for use .14
Annex A (normative) Test methods .16
Annex B (informative) Rationale statement .27
Annex C (informative) Lumen size and its effect on flowrate .28
Annex D (informative) Schematic of suction equipment .29
Bibliography .30
iv © ISO 2015 – All rights reserved

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SIST EN ISO 10079-1:2016
ISO 10079-1:2015(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 10079-1:1999), 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 Annex B, Annex C, and Annex 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 (*) at the beginning of the paragraph 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 into 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.
Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
© ISO 2015 – All rights reserved v

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SIST EN ISO 10079-1:2016

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SIST EN ISO 10079-1:2016
INTERNATIONAL STANDARD ISO 10079-1:2015(E)
Medical suction equipment —
Part 1:
Electrically powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for electrically powered medical
and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals,
for domiciliary care of patients and for field and transport use.
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-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) 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 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
1)
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

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.
© ISO 2015 – All rights reserved 1

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SIST EN ISO 10079-1:2016
ISO 10079-1:2015(E)

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 60529, Degrees of protection provided by enclosures (IP Code)
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 60601-1-11:2010, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services environment
IEC/TR 60878, Graphical symbols for electrical equipment in medical practice
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
EN 1041, Information suppli
...