EN 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 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
• Withdrawal Date: 31-May-2013
• ICS: 11.020.10 - Health care services in general
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-Dec-2018
• Completion Date: 31-Dec-2018
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 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)

Relations

• Replaced By: EN 60601-1-11:2015 - 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
• Effective Date: 28-Jan-2023

Standards Content (Sample)

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 requ
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