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 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. 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.

Medizinische elektrische Geräte – Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale – Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung

Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

La CEI 60601-1-11:2010 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux destinés par leur fabricant à être utilisés dans l'environnement des soins À domicile sans distinguer si l'appareil électromédical ou le système électromédical est prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. La CEI 60601-1-11:2010 est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale CEI 60601-1:2005 et à servir de base pour les normes particulières. Le comité recommande que le contenu de la présente publication soit adopté pour mise en oeuvre au niveau national au plus tôt 3 ans après la date de publication.

Medicinska električna oprema - 1-11. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za medicinsko električno opremo in medicinske električne sisteme, ki se uporabljajo v okolju domače zdravstvene oskrbe (IEC 60601-1-11:2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV, v nadaljevanju ME OPREMA in ME SISTEMI, ki so namenjeni uporabi s strani neusposobljenega upravljalca ali usposobljenega zdravstvenega osebja. Ta mednarodni standard ne velja za ME opremo in ME SISTEME, ki se uporabljajo izključno pri nujnih zdravstvenih storitvah ali izključno v strokovnih zdravstvenih ustanovah.

General Information

Status
Withdrawn
Publication Date
03-Jun-2010
Current Stage
6060 - Document made available
Due Date
04-Jun-2010
Completion Date
04-Jun-2010

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung (IEC 60601-1-11:2010)Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile (CEI 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 60601-1-11:2010)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1-11:2010SIST EN 60601-1-11:2010en01-september-2010SIST EN 60601-1-11:2010SLOVENSKI

STANDARD
SIST EN 60601-1-11:2010
EUROPEAN STANDARD EN 60601-1-11 NORME EUROPÉENNE
EUROPÄISCHE NORM June 2010

CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC -

All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-1-11:2010 E
ICS 11.040
English version
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 60601-1-11:2010)

Appareils électromédicaux -
Partie 1-11: Exigences générales
pour la sécurité de base et les performances essentielles -
Norme collatérale: Exigences
pour les appareils électromédicaux

et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile(CEI 60601-1-11:2010)

Medizinische elektrische Geräte -
Teil 1-11: Besondere Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale -
Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte
und medizinische elektrische Systeme
für die medizinische Versorgung
in häuslicher Umgebung (IEC 60601-1-11:2010)

This European Standard was approved by CENELEC on 2010-06-01. 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 Central Secretariat 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 Central Secretariat 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. SIST EN 60601-1-11:2010

EN 60601-1-11:2010 - 2 - Foreword The text of document 62A/693/FDIS, future edition 1 of IEC 60601-1-11, 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 was approved by CENELEC as EN 60601-1-11 on 2010-06-01. This EN 60601-1-11:2010 constitutes a collateral standard to EN 60601-1:2006, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: – latest date by which the EN has to be implemented

at national level by publication of an identical
national standard or by endorsement
(dop)
2011-03-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)

2013-06-01 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 7.2.1 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: SIST EN 60601-1-11:2010

- 3 - EN 60601-1-11:2010 – “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 (*). This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-1-11:2010 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: [2] IEC 60065:2001 NOTE

Harmonized as EN 60065:2002 (modified). [3] IEC 60335-1:2001 NOTE
Harmonized as EN 60335-1:2002 (modified). [4] IEC 60364 series NOTE
Harmonized in HD 60364 series (partially modified). [5] IEC 60721-3-7:1995 NOTE
Harmonized as EN 60721-3-7:1995 (not modified). [7] IEC 60950-1:2005 NOTE
Harmonized as EN 60950-1:2006 (modified). [8] IEC 61032:1997 NOTE
Harmonized as EN 61032:1998 (not modified). [10] ISO 10651-2:2004 NOTE

Harmonized as EN ISO 10651-2:2004 (not modified). __________ SIST EN 60601-1-11:2010

EN 60601-1-11:2010 - 4 - Annex ZA
(normative)

Normative references to international publications with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

NOTE

When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.

Publication Year Title EN/HD Year
IEC 60068-2-27 2008 Environmental testing -
Part 2-27: Tests - Test Ea and guidance: Shock EN 60068-2-27 2009
IEC 60068-2-31 2008 Environmental testing -

Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens EN 60068-2-31 2008

IEC 60068-2-64 2008 Environmental testing -

Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance EN 60068-2-64 2008

IEC 60529 1989 Degrees of protection provided
by enclosures (IP Code) EN 60529 + corr. May
1991 1993
IEC 60601-1
2005 Medical electrical equipment -
Part 1: General requirements for basic
safety and essential performance EN 60601-1 + corr. March
2006 2010
IEC 60601-1-2 (mod) 2007 Medical electrical equipment -

Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March

2007 2010
IEC 60601-1-6 2010 Medical electrical equipment -

Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 2010

IEC 60601-1-8 2006 Medical electrical equipment -

Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March

2007 2010

CISPR 11 (mod) 2009 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement EN 55011 2009

SIST EN 60601-1-11:2010
- 5 - EN 60601-1-11:2010 Annex ZZ (informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. SIST EN 60601-1-11:2010

SIST EN 60601-1-11:2010

IEC 60601-1-11Edition 1.0 2010-04INTERNATIONAL STANDARD NORME INTERNATIONALEMedical 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
Appareils électromédicaux –

Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l’environnement des soins à domicile

INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XAICS 11.040 PRICE CODECODE PRIXISBN 978-2-88910-920-3SIST EN 60601-1-11:2010

– 2 – 60601-1-11 © IEC:2010 CONTENTS

FOREWORD...........................................................................................................................4 INTRODUCTION.....................................................................................................................7 1 Scope, object and related standards.................................................................................8 1.1 * Scope...................................................................................................................8 1.2 Object.....................................................................................................................8 1.3 Related standards...................................................................................................8 1.3.1 IEC 60601-1................................................................................................8 1.3.2 Particular standards....................................................................................8 2 Normative references.......................................................................................................9 3 Terms and definitions.......................................................................................................9 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............11 4.2.2 * Environmental operating conditions.........................................................12 4.2.3 * Environmental shock to TRANSIT-OPERABLE ME EQUIPMENT........................13 5 * General requirements for testing ME EQUIPMENT...........................................................14 6 * Classification of ME EQUIPMENT and ME SYSTEMS...........................................................15 7 ME EQUIPMENT identification, marking and documents.....................................................15 7.1 * USABILITY of the ACCOMPANYING DOCUMENTS........................................................15 7.2 * Additional requirements for marking of IP classification.......................................16 7.3 ACCOMPANYING DOCUMENTS....................................................................................16 7.3.1 Contact information...................................................................................16 7.3.2 LAY OPERATOR briefing information.............................................................16 7.4 Instructions for use................................................................................................17 7.4.1 Additional requirements for warning and safety notices..............................17 7.4.2 * Additional requirements for an electrical power source............................17 7.4.3 Additional requirements for ME EQUIPMENT description...............................18 7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE..................18 7.4.5 Additional requirements for operating instructions......................................18 7.4.6 Additional requirements for ME EQUIPMENT messages.................................18 7.4.7 * Additional requirements for cleaning, disinfection and sterilization..........19 7.4.8 Additional requirements for maintenance...................................................19 7.4.9 Additional requirements for environmental protection.................................19 7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS........................20 7.5 Technical description.............................................................................................20 7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT..........................................20 7.5.2 Additional requirements for professional hygienic maintenance.................20 8 Protection against excessive temperatures and other HAZARDS.......................................20 8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and ME SYSTEMS...........................................................................................................20 8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS..........20 8.3 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS..............................................................................21 8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT.........................21 SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 3 – 8.3.2 * Ingress of water or particulate matter into ME SYSTEMS............................21 8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT and ME SYSTEM................................................................................21 9 Accuracy of controls and instruments and protection against hazardous outputs............22 10 Construction of ME EQUIPMENT........................................................................................22 10.1 * Additional requirements for mechanical strength.................................................22 10.1.1 General requirements for mechanical strength...........................................22 10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE ME EQUIPMENT............................................................................................24 10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE ME EQUIPMENT............................................................................................25 10.2 * Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE....................26 10.3 Additional requirements for actuating parts of controls of ME EQUIPMENT................27 11 * Protection against strangulation or asphyxiation...........................................................27 12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS....................................................................................................................27 12.1 Emissions classification.........................................................................................28 12.2 Protection of the PUBLIC MAINS NETWORK................................................................28 12.3 * Additional technical description requirements applicable to ME EQUIPMENT and ME SYSTEMS....................................................................................................28 12.4 * Additional requirements applicable to ME EQUIPMENT and ME SYSTEMS specified for use only in a shielded location...........................................................28 12.5 * Additional requirements for ELECTROSTATIC DISCHARGE (ESD) tests.......................28 13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS................28 13.1 * Additional requirement for generation of ALARM SIGNALS......................................28 13.2 * Additional requirement for ALARM SIGNAL volume.................................................29 Annex A (informative)

General guidance and rationale.........................................................30 Annex B (informative)

Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS....................................................................................................................49 Annex C (informative)

Symbols on marking..........................................................................53 Bibliography..........................................................................................................................54 Index of defined terms used in this collateral standard..........................................................56

Figure 1 – Small finger probe ∅ 5,6......................................................................................15

Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE...............................23 Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE......................................24 Table A.1 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress of water and particulate matter requirements..........................................42 Table A.2 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration...........................................................................................43 Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts...................49 Table B.2 – ACCOMPANYING DOCUMENTS, general...................................................................49 Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use.................................................51 Table B.4 – ACCOMPANYING DOCUMENTS, instructions for use (continued)...............................52 Table B.5 – ACCOMPANYING DOCUMENTS, technical description...............................................52 Table C 1 – General symbols................................................................................................53 SIST EN 60601-1-11:2010

– 4 – 60601-1-11 © IEC:2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________

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

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, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested 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 interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.

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 60601-1-11 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. It is published as a double logo standard. This first edition constitutes a collateral standard to IEC 60601-1:2005 (third edition): Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 5 – The text of this collateral standard is based on the following documents of IEC: FDIS Report on voting 62A/693/FDIS 62A/696/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, the standard has been approved by 17 P-members out of 17 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 7.2.1 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. SIST EN 60601-1-11:2010

– 6 – 60601-1-11 © IEC:2010 The committee has decided that the contents of this amendment and the base 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.

SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 7 – INTRODUCTION Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for monitoring, treatment or diagnosis of PATIENTS in the HOME HEALTHCARE ENVIRONMENT (see

3.2). The safety of MEDICAL ELECTRICAL EQUIPMENT in this uncontrolled environment with regard to the electrical installation and its related safety and protection means is a cause for concern. The potential lack of training of the LAY OPERATOR and possibly of those supervising the use of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM and their level of education need to be addressed in the development of the ACCOMPANYING DOCUMENTS and in the relevant marking on the equipment itself so that this material can be understood. This collateral standard gives special guidance on how this should be addressed in the instructions for use. 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 a

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