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

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), as defined in 3.1.
NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use.
The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the
MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT.
The EMS ENVIRONMENT includes
– responding to and providing life support at the scene of an emergency to a PATIENT
reported as experiencing injury or illness in a pre-hospital setting, and transporting the
PATIENT, while continuing such life support care, to an appropriate professional healthcare
facility for further care.
– providing monitoring, treatment or diagnosis during transport between professional
healthcare facilities.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in
professional healthcare facilities covered by IEC 60601-1 without the additions of
IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely
intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple
use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within
the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare
facility environment.
NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical
sources and outdoor environmental conditions.

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
13-Aug-2015
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
15-Jun-2015
Due Date
20-Aug-2015
Completion Date
14-Aug-2015

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SLOVENSKI STANDARD
SIST EN 60601-1-12:2015
01-september-2015
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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
SIST EN 60601-1-12:2015 en

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

---------------------- Page: 1 ----------------------
SIST EN 60601-1-12:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-1-12:2015
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
---------------------- Page: 3 ----------------------
SIST EN 60601-1-12:2015
EN 60601-1-12:2015
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).
---------------------- Page: 4 ----------------------
SIST EN 60601-1-12:2015
EN 60601-1-12:2015
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
---------------------- Page: 5 ----------------------
SIST EN 60601-1-12:2015
EN 60601-1-12:2015
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
---------------------- Page: 6 ----------------------
SIST EN 60601-1-12:2015
EN 60601-1-12:2015
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.
---------------------- Page: 7 ----------------------
SIST EN 60601-1-12:2015
EN 60601-1-12:2015
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.
---------------------- Page: 8 ----------------------
SIST EN 60601-1-12:2015
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

---------------------- Page: 9 ----------------------
SIST EN 60601-1-12:2015
– 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 ............................................................................................. 16

6.3.1 Additional general requirements .................................................................... 16

6.3.2 * Additional requirements for an electrical power source ................................ 17

6.3.3 Additional requirements for ME EQUIPMENT start-up PROCEDURE ...................... 17

6.3.4 * Additional requirements for operating instructions ....................................... 18

6.3.5 Additional requirements for ME EQUIPMENT messages ..................................... 18

6.4 Technical description – FIXED or PERMANENTLY INSTALLED CLASS I

ME EQUIPMENT ....................................................................................................... 18

7 * Protection against electrical HAZARDS from ME EQUIPMENT ............................................ 18

8 Protection against excessive temperatures and other HAZARDS ...................................... 19

8.1 Additional requirements for ingress of water or particulate matter into

ME EQUIPMENT and ME SYSTEMS ............................................................................. 19

8.1.1 * Ingress of water or particulate matter into ME EQUIPMENT ............................. 19

8.1.2 * Ingress of water or particulate matter into ME SYSTEMS ................................ 19

8.2 Additional requirements for interruption of the power supply to ME EQUIPMENT

and ME SYSTEM ...................................................................................................... 19

8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for

ME EQUIPMENT ....................................................................................................... 20

9 * Accuracy of controls and instruments and protection against hazardous outputs ......... 21

10 Construction of ME EQUIPMENT ........................................................................................ 21

10.1 * Additional requirements for mechanical strength of ME EQUIPMENT intended

for the EMS ENVIRONMENT ....................................................................................... 21

10.1.1 General requirements for mechanical strength ............................................... 21

10.1.2 * Requirements for mechanical strength for FIXED or PERMANENTLY

INSTALLED ME EQUIPMENT intended for use in a road ambulance ...................... 22

10.1.3 * Requirements for mechanical strength for TRANSPORTABLE

ME EQUIPMENT ................................................................................................ 23

---------------------- Page: 10 ----------------------
SIST EN 60601-1-12:2015
IEC 60601-1-12:2014 © IEC 2014 – 3 –
10.1.4 * Requirements for mechanical strength for ME EQUIPMENT intended for

airborne use .................................................................................................. 24

10.2 Requirements for mounting of ME EQUIPMENT ......................................................... 25

11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and

ME SYSTEMS ................................................................................................................... 25

Annex A (informative) General guidance and rationale ......................................................... 26

A.1 General guidance .................................................................................................. 26

A.2 Rationale for particular clauses and subclauses .................................................... 28

Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT

and ME SYSTEMS .................................................................................................................... 42

B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ...................... 42

B.2 ACCOMPANYING DOCUMENTS, instructions for use .................................................... 42

B.3 ACCOMPANYING DOCUMENTS, technical description .................................................. 43

Annex C (informative) Symbols on marking .......................................................................... 44

Bibliography .......................................................................................................................... 46

Index of defined terms used in this collateral standard .......................................................... 48

Figure A.1 – Saturation water vapour pressure as function of temperature ............................ 31

Table 1 – Mechanical strength test applicability .................................................................... 22

Table A.1 – Saturation water vapour pressure as function of temperature ............................. 32

Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ................... 42

Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use ................................................. 42

Table B.3 – ACCOMPANYING DOCUMENTS, technical description ............................................... 43

Table C.1 – General symbols ................................................................................................ 44

---------------------- Page: 11 ----------------------
SIST EN 60601-1-12:2015
– 4 – IEC 60601-1-12:2014 © IEC 2014
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_______________
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
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

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in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

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6) All users should ensure that they have the latest edition of this publication.

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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-1-12 has been prepared by a joint working group of

IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of

IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee

SC3: Lung ventilators and related devices, of ISO technical committee 121: Anaesthetic and

respiratory equipment.

This first edition constitutes a collateral standard to IEC 60601-1 (third edition): Medical

electrical equipment – Part 1: General requirements for basic safety and essential

performance hereafter referred to as the general standard.
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SIST EN 60601-1-12:2015
IEC 60601-1-12:2014 © IEC 2014 – 5 –
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/932/FDIS 62A/938/RVD

Full information on the voting for the approval of this collateral standard can be found in the

report on voting indicated in the above table. In ISO, this International Standard has been

approved by 18 P-members out of 19 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In the 60601 series of publications, collateral standards specify general requirements for

safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or

– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the

general standard (e.g. ALARM SYSTEMS).
In this collateral standard, the following print types are used:
– requirements and definitions: roman type.
– test specifications: italic type.

informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type.

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the numbered divisions within the table of contents, inclusive of all

subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.3.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this collateral standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

Clauses, subclauses and definitions for which a rationale is provided in informative Annex A

are marked with an asterisk (*).

A list of all parts of the IEC 60601 series, published under the general title: Medical electrical

equipment, can be found on the IEC website.
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SIST EN 60601-1-12:2015
– 6 – IEC 60601-1-12:2014 © IEC 2014

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of Member Bodies and National Committees is drawn to the fact that equipment

manufacturers and testing organizations may need a transitional period following publication of a new, amended or

revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip

themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this

publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct
re print this document using a
understanding of its contents. Users should therefo
colour printer.
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SIST EN 60601-1-12:2015
IEC 60601-1-12:2014 © IEC 2014 – 7 –
INTRODUCTION

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 (see 3.1). 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.
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SIST EN 60601-1-12:2015
– 8 – IEC 60601-1-12:2014 © IEC 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
1 Scope, object and related standards
1.1 * Scope
This International Standa
...

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