1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medi
2、cal electrical systems used in the home healthcare environmentBS EN 60601-1-11:2010National forewordThis British Standard is the UK implementation of EN 60601-1-11:2010. It isidentical to IEC 60601-1-11:2010.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrica
3、l Equipment in Medical Practice, to Subcommittee CH/62/1,Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acont
4、ract. Users are responsible for its correct application. BSI 2010ISBN 978 0 580 57620 1ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 July 2010.Am
5、endments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-1-11:2010EUROPEAN STANDARD EN 60601-1-11 NORME EUROPENNE EUROPISCHE NORM June 2010 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komit
6、ee fr 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: Gen
7、eral 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 lectromdicaux - Partie 1-11: Exigences gnrales pour la scurit de ba
8、se et les performances essentielles - Norme collatrale: Exigences pour les appareils lectromdicaux et les systmes lectromdicaux utiliss dans lenvironnement des soins domicile(CEI 60601-1-11:2010) Medizinische elektrische Gerte - Teil 1-11: Besondere Festlegungen fr die Sicherheit einschlielich der w
9、esentlichen Leistungsmerkmale - Ergnzungsnorm: Anforderungen an medizinische elektrische Gerte und medizinische elektrische Systeme fr die medizinische Versorgung in huslicher Umgebung (IEC 60601-1-11:2010) This European Standard was approved by CENELEC on 2010-06-01. CENELEC members are bound to co
10、mply 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 S
11、ecretariat 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
12、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, Norw
13、ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 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 T
14、C 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
15、 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 foll
16、owing 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 h
17、as 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 EL
18、ECTRICAL 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
19、 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 with
20、in 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” foll
21、owed 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 des
22、cribed in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: BS 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 r
23、equirement 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 as
24、terisk (*). 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 t
25、ext 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
26、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 NOT
27、E Harmonized as EN 61032:1998 (not modified). 10 ISO 10651-2:2004 NOTE Harmonized as EN ISO 10651-2:2004 (not modified). _ BS EN 60601-1-11:2010EN 60601-1-11:2010 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The followin
28、g 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 c
29、ommon 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
30、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 I
31、EC 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 sta
32、ndard: 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
33、 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
34、Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement EN 55011 2009 BS 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 prepar
35、ed 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 t
36、he 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. BS EN 60601-1-11:2010 2 60601-1-11 IEC:2010 CONTENTS INTRODUCTION.7 1 Scope, object and related standards.8
37、 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
38、 EQUIPMENT.11 4.2.1 * Environmental conditions of transport and storage between uses11 4.2.2 * Environmental operating conditions.12 4.2.3 * Environmental shock to TRANSIT-OPERABLE ME EQUIPMENT13 5 * General requirements for testing ME EQUIPMENT .14 6 * Classification of ME EQUIPMENT and ME SYSTEMS.
39、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 DOCUMENTS16 7.3.1 Contact information .16 7.3.2 LAY OPERATOR briefing information.16 7.4 Instructions for use
40、17 7.4.1 Additional requirements for warning and safety notices17 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 op
41、erating instructions18 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 requirem
42、ents for ME EQUIPMENT and ME SYSTEMS20 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
43、, 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 EQUIPM
44、ENT.21 BS EN 60601-1-11:201060601-1-11 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 SYSTEM21 9 Accuracy of controls and instruments and protection against hazardous ou
45、tputs 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 TRANS
46、IT-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
47、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 u
48、se 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 v
49、olume .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 marking53 Bibliography54 Index of defined terms used in this collateral standard56 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
