EN 60601-1-11:2010

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
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

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

(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
- 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

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.
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 and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for the development of particular standards.
– 8 – 60601-1-11 © IEC: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
1 Scope, object and related standards 1.1 * Scope 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 by their MANUFACTURER for use in the HOME HEALTHCARE ENVIRONMENT, as defined in
3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. NOTE 1 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use by emergency medical services or solely for use in professional healthcare facilities. NOTE 2 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding. 1.2 Object 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. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: • "the general standard" designates IEC 60601-1 alone; • "this collateral standard" designates IEC 60601-1-11 alone; • "this standard" designates the combination of the general standard and this collateral standard. 1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard. SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 9 – 2 Normative references 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 1 The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography on page 54. IEC 60068-2-27:2008, Environmental testing – Part 2-27: Tests – Ea and guidance: Shock IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough handling shocks, primarily for equipment-type specimens IEC 60068-2-64:2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
Amendment 1 (1999) 1) IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –Requirements and tests IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability 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 CISPR 11:2009, Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics - Limits and methods of measurement 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-8:2006 and the following definitions apply. NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise. NOTE 2 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM. NOTE 3 An index of defined terms used in this collateral standard is found beginning on page 56. ————————— 1) There exists a consolidated edition 2.1 including IEC 60529:1989 and Amendment 1 (1999). SIST EN 60601-1-11:2010

– 10 – 60601-1-11 © IEC:2010 3.1
* BODY-WORN term referring to TRANSPORTABLE equipment whose INTENDED USE includes operation while being worn by a PATIENT or attached to a PATIENT'S clothing NOTE TRANSPORTABLE equipment can be both BODY-WORN and HAND-HELD. 3.2
HOME HEALTHCARE ENVIRONMENT dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present NOTE 1 Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, multiple treatment facilities and emergency medical services. NOTE 2 For the purpose of this collateral standard, nursing homes are considered the HOME HEALTHCARE ENVIRONMENT. NOTE 3 Other places where PATIENTS are present include the outdoor environment and in vehicles. EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors 3.3
* LAY term referring to nonprofessional or professional without relevant specialized training EXAMPLES LAY OPERATOR, LAY RESPONSIBLE ORGANIZATION 3.4
LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEM ME EQUIPMENT or ME SYSTEM that includes at least one FUNCTION that is intended to actively keep alive or resuscitate a PATIENT and the failure of which is likely to lead to serious injury or death of a PATIENT [IEC 60601-1-2:2007, definition 3.18, modified] EXAMPLE A ventilator for a ventilator-dependent PATIENT intended for use in the HOME HEALTHCARE ENVIRONMENT. 3.5
SHELF LIFE maximum period of time that an item can be stored prior to its first use under the conditions described in its labelling and remain suitable for use 3.6
TRANSIT-OPERABLE term referring to TRANSPORTABLE equipment whose INTENDED USE includes operation while it is being moved EXAMPLES TRANSPORTABLE ME EQUIPMENT that is BODY-WORN, HAND-HELD, attached to a wheelchair, or used in a car, bus, train, boat or plane. NOTE For the purpose of this standard, TRANSIT-OPERABLE use in the HOME HEALTHCARE ENVIRONMENT can include use indoors, outdoors and in vehicles. 3.7
USABILITY ENGINEERING application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of tools, machines, ME EQUIPMENT, devices, systems, tasks, jobs, and environments to achieve adequate USABILITY SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 11 – 3.8
USABILITY ENGINEERING FILE set of RECORDS and other documents that are produced by USABILITY ENGINEERING activities 3.9
USABILITY SPECIFICATION documentation defining the OPERATOR-EQUIPMENT INTERFACE requirements related to USABILITY 3.10
VALIDATION confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled NOTE 1 The term “validated” is used to designate the corresponding status. NOTE 2 The use conditions for VALIDATION can be real or simulated. [ISO 9000:2000, definition 3.8.5] 4 General requirements 4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS For ME EQUIPMENT or ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT, the characteristics of the SUPPLY MAINS specified in 4.10.2 of the general standard apply, except for replacement of the fifth dash as follows: – for non-LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEMS, no voltage in excess of 110 % or lower than 85 % of the NOMINAL voltage between any of the conductors of the system or between any of these conductors and earth; and – for LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEMS, no voltage in excess of 110 % or lower than 80 % of the NOMINAL voltage between any of the conductors of the system or between any of these conductors and earth. 4.2 Environmental conditions for ME EQUIPMENT NOTE In IEC 60601-1:2005, the MANUFACTURER specifies the permissible conditions of use, including conditions for transport and storage in the technical description (see 7.9.3.1, second dash). These conditions are referenced in requirements for testing throughout the general standard, (e.g. 5.3 and 11.1.1). 4.2.1 * Environmental conditions of transport and storage between uses The instructions for use shall indicate the permissible environmental conditions of transport and storage of ME EQUIPMENT after the ME EQUIPMENT has been removed from its protective packaging and subsequently between uses. Unless otherwise indicated in the instructions for use or if the ME EQUIPMENT is STATIONARY, the ME EQUIPMENT shall comply with this standard and shall remain operational in NORMAL USE within its specification after transport or storage in the following environmental temperature range: – – 25 °C without relative humidity control; and – + 70 °C at a relative humidity up to 93 %, non-condensing; after having been removed from its protective packaging and subsequently between uses. NOTE 1 This represents class 7K3 as described in IEC/TR 60721-4-7:2001
[6] 2). ————————— 2)
Figures in square brackets refer to the Bibliography. SIST EN 60601-1-11:2010

– 12 – 60601-1-11 © IEC:2010 If the instructions for use state a more restricted range of environmental transport and storage conditions between uses, these environmental conditions shall be:
– justified in the RISK MANAGEMENT FILE; – marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the more restricted range need only be disclosed in the instructions for use; and – marked on the carrying case, if the instructions for use indicate the ME EQUIPMENT is intended to be transported or stored in a carrying case between uses. Compliance is checked by the following test and, when a more restricted range is stated in the instructions for use, inspection of the RISK MANAGEMENT FILE. a) Prepare the ME EQUIPMENT for transportation or storage according to instructions for use. EXAMPLES Removal of batteries, emptying fluid reservoirs b) Expose the ME EQUIPMENT at its lowest specified environmental transport and storage conditions (temperature 04− °C) for: – at least 24 h; or – ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h. c) Then expose the ME EQUIPMENT at its highest specified environmental transport and storage conditions (temperature 40+ °C and relative humidity ± 3 %) for: – at least 24 h; or
– ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h. The transition from low to high conditions should be made slowly enough to provide a non-condensing environment. NOTE 2 The intent of specifying a minimum duration of the exposure to both the low and high temperature conditions is to ensure that the entire ME EQUIPMENT reaches the stated conditions. d) At the end of this conditioning period, allow the ME EQUIPMENT to return and stabilize at the operating conditions of NORMAL USE. e) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE. 4.2.2 * Environmental operating conditions The instructions for use shall indicate the permissible environmental operating conditions of the ME EQUIPMENT. NOTE 1 The environmental operating conditions should be marked on TRANSIT-OPERABLE ME EQUIPMENT, unless such marking is not practicable, in which case the environmental operating conditions need only be disclosed in the instructions for use. Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with its specifications and all the requirements of this standard when operated in NORMAL USE under the following environmental operating conditions: – a temperature range of + 5 °C to + 40 °C; – a relative humidity range of 15 % to 93 %, non-condensing; and – an atmospheric pressure range of 700 hPa to 1 060 hPa. NOTE 2 This represents class 7K1 as described in IEC/TR 60721-4-7:2001
[6]. If the instructions for use state a more restricted range of environmental operating conditions, these conditions shall be: SIST EN 60601-1-11:2010

60601-1-11 © IEC:2010 – 13 – – justified in the RISK MANAGEMENT FILE; – marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the more restricted range need only be disclosed in the instructions for use; and – marked on the carrying case if the instructions for use indicate the ME EQUIPMENT is intended to be operated in a carrying case. The ME EQUIPMENT shall comply with its specifications and all the requirements of this standard when operated in NORMAL USE under the specified environmental operating conditions. Compliance is checked by the following test and, when a more restricted range is stated in the instructions for use, inspection of the RISK MANAGEMENT FILE: a) Expose the ME EQUIPMENT to the ambient conditions for: – at least 6 h, or
– ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h. b) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE. c) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE while at the lowest specified atmospheric pressure. d) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE while at the highest specified atmospheric pressure. NOTE 3 For ME EQUIPMENT that utilizes or measures gas or pressures, evaluation of BASIC SAFETY and ESSENTIAL PERFORMANCE while the pressure changes can be needed. e) Cool the ME EQUIPMENT to its lowest specified environmental operating conditions (temperature 04− °C and relative humidity less than or equal to 15 %). f) Hold the ME EQUIPMENT at its lowest specified environmental operating conditions: – for at least 6 h, or
– ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h. g) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY and ESSENTIAL PERFORMANCE. h) Warm the ME EQUIPMENT to its highest specified en
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