EN 60601-1-12:2015

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 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme in der Umgebung für den Notfalleinsatz

Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

L'IEC 60601-1-12:2014 constitue une norme collatérale de l'IEC 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles désignée ci-après par norme générale. La pratique médicale utilise de plus en plus des appareils électromédicaux et des systèmes électromédicaux pour la surveillance, le traitement ou le diagnostic des patients dans l'environnement des services médicaux d'urgence. La sécurité des appareils électromédicaux dans cet environnement particulièrement difficile et non contrôlé, est source de préoccupation. La présente norme collatérale a été élaborée grâce aux contributions de médecins cliniciens, d'ingénieurs et d'autorités de tutelle. La terminologie, les exigences, les recommandations générales et les lignes directrices contenues dans la présente norme collatérale ont pour objectif d'être utiles aux fabricants d'appareils électromédicaux et de systèmes électromédicaux et aux comités techniques responsables de l'élaboration des normes particulières. La présente Norme internationale s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, désignés ci-après par appareils EM et systèmes EM, destinés, comme indiqué dans les instructions d'utilisation, par leur fabricant à être utilisés dans l'environnement SMU (environnement des Services Médicaux d'Urgence). L'objet de la présente norme collatérale est de fournir des exigences générales pour les appareils EM et les systèmes EM acheminés et utilisés sur les lieux d'une intervention en urgence, ainsi que pour leur transport, dans des situations où les conditions ambiantes sont différentes des conditions intérieures. La présente norme collatérale est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale et à servir de base pour les normes particulières.

Medicinska električna oprema - 1-12. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za elektromedicinsko opremo in elektromedicinske sisteme, namenjene za uporabo v okolju nujne medicinske pomoči

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM), ki so namenjeni za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI (OKOLJE EMS), kot je PROIZVAJALEC navedel v navodilih za uporabo in
kot je določeno v poglavju 3.1. OPOMBA 1 Za namene tega standarda je namen PROIZVAJALCA naveden v navodilih za uporabo. ODGOVORNA ORGANIZACIJA in IZVAJALEC morata upoštevati, da se lahko zaradi uporabe, ki ni skladna z NAMERAVANO UPORABO PROIZVAJALCA, PACIENT znajde v NEVARNEM STANJU. OKOLJE NUJNE MEDICINSKE POMOČI vključuje:
– odzivanje na in oživljanje PACIENTA na mestu intervencije, ki je poškodovan ali pod vplivom bolezni v predbolnišničnem okolju, ter prevoz PACIENTA do primerne strokovne zdravstvene ustanove za nadaljnje zdravljenje, med katerim se nadaljuje z oživljanjem.
– nadzorovanje, zdravljenje ali diagnosticiranje med prevozom med strokovnimi zdravstvenimi ustanovami.
Ta mednarodni standard se ne uporablja za ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME, namenjene izključno za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE ki so zajeti v standardu IEC 60601-1-11, ali namenjene izključno za uporabo v strokovnih zdravstvenih ustanovah, ki so zajeti v standardu IEC 60601-1 brez dodatkov standarda IEC 60601-1-11 ali tega spremljevalnega standarda. ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI so pogosto namenjeni uporabi v različnih okoljih. Taka ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICISNKI SISTEMI so lahko namenjeni uporabi v različnih okoljih in so tako v področju uporabe tega standarda tudi, če so med drugim namenjeni za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI.
PRIMER: ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEMI namenjeni tako za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI in okolju strokovnih zdravstvenih ustanov.
OPOMBA 2: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI, namenjeni uporabi v OKOLJU NUJNE MEDICINSKE POMOČI, se lahko uporabljajo na mestih z nezanesljivimi električnimi viri in v zunanjih okoljskih pogojih.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 30-Dec-2018
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-1-12:2015 - 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

Relations

• Amended By: EN 60601-1-12:2015/A1:2020 - 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
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DHOHNWURPHGLFLQVNRRSUHPR
LQHOHNWURPHGLFLQVNHVLVWHPHQDPHQMHQH]DXSRUDERYRNROMXQXMQHPHGLFLQVNH
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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
Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte und medizinische elektrische Systeme in der
Umgebung für den Notfalleinsatz
Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Exigences pour les appareils
électromédicaux et les systèmes électromédicaux destinés à être utilisés dans
l'environnement des services médicaux d'urgence
Ta slovenski standard je istoveten z: EN 60601-1-12:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-1-12

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040
English Version
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 60601-1-12:2014)
Appareils électromédicaux - Partie 1-12: Exigences Medizinische elektrische Geräte - Teil 1-12: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Exigences pour les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils électromédicaux et les systèmes électromédicaux Anforderungen an medizinische elektrische Geräte und
destinés à être utilisés dans l'environnement des services medizinische elektrische Systeme in der Umgebung für den
médicaux d'urgence Notfalleinsatz
(IEC 60601-1-12:2014) (IEC 60601-1-12:2014)
This European Standard was approved by CENELEC on 2014-07-24. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-12:2015 E
Foreword
The text of document 62A/932/FDIS, future edition 1 of IEC 60601-1-12, prepared by SC 62A
"Common aspects of electrical equipment used in medical practice", of IEC/TC 62 "Electrical
equipment in medical practice", was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-1-12:2015.
The following dates are fixed:
– latest date by which the document has to be implemented at (dop) 2015-11-22
national level by publication of an identical national
standard or by endorsement
– latest date by which the national standards conflicting with (dow) 2018-12-31
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directives 93/42/EEC and 90/385/EEC, see informative Annexes ZZA
and ZZB, which are integral parts of this document.
Endorsement notice
The text of the International Standard IEC 60601-1-12:2014 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60038:2009 NOTE Harmonized as EN 60038:2011 (modified).
IEC 60065 NOTE Harmonized as EN 60065.
IEC 60335-1:2010 NOTE Harmonized as EN 60335-1:2012 (modified).
IEC 60364 NOTE Harmonized in HD 384 / HD 60364 series (partly modified).
IEC 60721-3-7:1995 NOTE Harmonized as EN 60721-3-7:1995 (not modified)
+ A1:1996 + A1:1997 (not modified).
IEC 60950-1:2005 NOTE Harmonized as EN 60950-1:2006 (modified).
IEC 61032:1997 NOTE Harmonized as EN 61032:1998 (not modified).
ISO 10651-2:2004 NOTE Harmonized as EN ISO 10651-2:2009 (not modified).
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Publication Year Title EN/HD Year
IEC 60068-2-27 2008 Environmental testing - EN 60068-2-27 2009
Part 2-27: Tests - Test Ea and guidance:
Shock
IEC 60068-2-31 2008 Environmental testing - EN 60068-2-31 2008
Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type
specimens
IEC 60068-2-64 2008 Environmental testing - EN 60068-2-64 2008
Part 2-64: Tests - Test Fh: Vibration,
broadband random and guidance
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
- - enclosures (IP Code) + corrigendum May 1993
+ A1 1999 + A1 2000
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
- - Part 1: General requirements for basic + corrigendum Mar. 2010
+ A1 2012 safety and essential performance + A1 2013
- - + A1/AC 2014
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2014
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
+ A1 2013 Part 1-6: General requirements for basic + A1 2015
safety and essential performance -
Collateral standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
- - Part 1-8: General requirements for basic + corrigendum Mar. 2010
+ A1 2012 safety and essential performance - + A1 2013
- - Collateral Standard: General requirements, + A1/AC 2014
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Publication Year Title EN/HD Year
IEC 60601-1-11 2015 Medical electrical equipment - EN 60601-1-11 2015
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
CISPR 11 (mod) 2009 Industrial, scientific and medical EN 55011 2009
equipment - Radio-frequency disturbance
characteristics - Limits and methods of
measurement
ISO 7000 2014 Graphical symbols for use on equipment - - -
Registered symbols
ISO 7010 2011 Graphical symbols - Safety colours and EN ISO 7010 2012
+ A1 2012 safety signs - Registered safety signs + A1 2014
+ A2 2012 + A2 2014
+ A3 2012 + A3 2014
+ A4 2013 + A4 2014
+ A5 2014 + A5 2015
ISO 15223-1 2012 Medical devices - Symbols to be used with EN ISO 15223-1 2012
medical device labels, labelling and
information to be supplied -
Part 1: General requirements
Annex ZZA
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
Annex ZZB
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex 1 of EU Directive 90/385/EEC of 20 June 1990 relating
to active implantable medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-1-12
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences pour les appareils électromédicaux

et les systèmes électromédicaux destinés à être utilisés dans l'environnement

des services médicaux d'urgence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040 ISBN 978-2-8322-1654-5

– 2 – IEC 60601-1-12:2014 © IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 * Object . 8
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 11
4.2 * Environmental conditions for ME EQUIPMENT . 11
4.2.1 * Environmental conditions of transport and storage between uses . 12
4.2.2 * Environmental operating conditions . 13
5 * Classification of ME EQUIPMENT and ME SYSTEMS . 15
6 ME EQUIPMENT identification, marking and documents . 16
6.1 * Additional requirements for legibility of markings . 16
6.2 * Additional requirements for marking of IP classification . 16
6.3 * Instructions for use .
...