1、 IEC 60601-1-11 Edition 2.0 2015-01 INTERNATIONAL STANDARD NORME INTERNATIONALE 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 h
2、ealthcare environment Appareils lectromdicaux Partie 1-11: Exigences gnrales pour la scurit de base et les performances essentielles Norme Collatrale: Exigences pour les appareils lectromdicaux et les systmes lectromdicaux utiliss dans lenvironnement des soins domicile IEC 60601-1-11:2015-01(en-fr)
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20、e.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-1-11 Edition 2.0 2015-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 1-11: General requirements for basic safety and ess
21、ential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Appareils lectromdicaux Partie 1-11: Exigences gnrales pour la scurit de base et les performances essentielles Norme Collatrale: Exigences pour
22、 les appareils lectromdicaux et les systmes lectromdicaux utiliss dans lenvironnement des soins domicile INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040 ISBN 978-2-8322-2180-8 Warning! Make sure that you obtained this publication from an authorized dis
23、tributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 60601-1-11:2015 IEC 2015 CONTENTS FOREWORD . 5 INTRODUCTION . 8 1 Scope, object and related standards 9 1.1 * Scope . 9 1.2 Object . 9 1.3 Related standards . 9 IEC 60601-1
24、9 1.3.1Particular standards . 10 1.3.2 2 Normative references 10 3 Terms and definitions 11 4 General requirements 12 4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 12 4.2 * Environmental conditions for ME EQUIPMENT 12 General . 12 4.2.1* Environmental conditions of
25、 transport and storage between uses 13 4.2.2* Environmental operating conditions . 14 4.2.3 5 * General requirements for testing ME EQUIPMENT . 16 6 * Classification of ME EQUIPMENT and ME SYSTEMS 17 7 ME EQUIPMENT identification, marking and documents 17 7.1 * USABILITY of the ACCOMPANYING DOCUMENT
26、S 17 7.2 * Additional requirements for marking of IP classification 18 7.3 ACCOMPANYING DOCUMENTS . 18 Contact information . 18 7.3.1LAY OPERATOR briefing information . 18 7.3.2 7.4 Instructions for use . 19 Additional requirements for warning and safety notices 19 7.4.1* Additional requirements for
27、 an electrical power source 19 7.4.2Additional requirements for ME EQUIPMENT description 20 7.4.3Additional requirements for ME EQUIPMENT start-up PROCEDURE 20 7.4.4Additional requirements for operating instructions 20 7.4.5Additional requirements for ME EQUIPMENT messages . 21 7.4.6* Additional req
28、uirements for cleaning, disinfection and sterilization . 21 7.4.7Additional requirements for maintenance . 21 7.4.8Additional requirements for environmental protection . 21 7.4.9Additional requirements for ME EQUIPMENT and ME SYSTEMS 22 7.4.10 7.5 Technical description 22 PERMANENTLY INSTALLED CLASS
29、 I ME EQUIPMENT 22 7.5.1Additional requirements for professional hygienic maintenance . 22 7.5.2 8 Protection against excessive temperatures and other HAZARDS 22 8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and ME SYSTEMS . 22 8.2 * Additional requirements for sterilizati
30、on of ME EQUIPMENT and ME SYSTEMS 23 8.3 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS 23 * Ingress of water or particulate matter into ME EQUIPMENT . 23 8.3.1IEC 60601-1-11:2015 IEC 2015 3 * Ingress of water or particulate matter into ME SYSTEMS
31、 23 8.3.2 8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT and ME SYSTEM . 23 8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE 24 * Indication of state 24 8.5.1Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 25 8.5.2 9 Accura
32、cy of controls and instruments and protection against hazardous outputs . 25 10 Construction of ME EQUIPMENT 25 10.1 * Additional requirements for mechanical strength . 25 General requirements for mechanical strength . 25 10.1.1* Requirements for mechanical strength for non-TRANSIT-OPERABLE 10.1.2 M
33、E EQUIPMENT 27 * Requirements for mechanical strength for TRANSIT-OPERABLE 10.1.3 ME EQUIPMENT 28 10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 29 11 * Protection against strangulation or asphyxiation 30 12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME
34、EQUIPMENT and ME SYSTEMS . 30 13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 30 13.1 * Additional requirement for generation of ALARM SIGNALS 30 13.2 * Additional requirement for ALARM SIGNAL volume . 30 Annex A (informative) General guidance and rationale . 31 A.1 Gen
35、eral guidance 31 A.2 Rationale for particular clauses and subclauses 32 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 51 B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 51 B.2 ACCOMPANYING DOCUMENTS, general 51 B.3 ACCOMPANYIN
36、G DOCUMENTS, instructions for use 51 B.4 ACCOMPANYING DOCUMENTS, technical description 53 Annex C (informative) Symbols on marking 54 Bibliography 56 Index of defined terms used in this collateral standard 58 Figure 1 Small finger probe 5,6 17 Figure A.1 Saturation water vapour pressure as function
37、of temperature 36 Table 1 Mechanical strength test applicability, non-TRANSIT-OPERABLE . 26 Table 2 Mechanical strength test applicability, TRANSIT-OPERABLE 27 Table A.1 Saturation water vapour pressure as function of temperature . 37 Table A.2 Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPM
38、ENT ENCLOSURE ingress of water and particulate matter requirements 46 Table A.3 Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration . 47 Table B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 51 Table B.2 ACCOMPANYING DOCUMENTS,
39、general . 51 Table B.3 ACCOMPANYING DOCUMENTS, instructions for use . 52 4 IEC 60601-1-11:2015 IEC 2015 Table B.4 ACCOMPANYING DOCUMENTS, technical description . 53 Table C.1 General symbols 54 IEC 60601-1-11:2015 IEC 2015 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Pa
40、rt 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 organizati
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