BS EN 60601-1-11:2015 – TC:2020 Edition
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Tracked Changes. Medical electrical equipment – 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
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 151 |
IEC 60601-1-11:2015 is available as /2 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies 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 home healthcare environment includes: – the dwelling place in which a patient lives; – other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: – correction of test method for relative humidity control at temperatures above 35 °C; – redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and – harmonizing with the changes to the amendments to the general standard and other collateral standards.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 86 | Foreword Endorsement notice |
| 88 | Annex ZA (normative) Normative references to international publications with their corresponding European publications |
| 90 | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives |
| 91 | English CONTENTS |
| 94 | FOREWORD |
| 97 | INTRODUCTION |
| 98 | 1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1 |
| 99 | 1.3.2 Particular standards 2 Normative references |
| 100 | 3 Terms and definitions |
| 101 | 4 General requirements 4.1 * Additional requirements for supply mains for me equipment and me systems 4.2 * Environmental conditions for me equipment 4.2.1 General |
| 102 | 4.2.2 * Environmental conditions of transport and storage between uses |
| 103 | 4.2.3 * Environmental operating conditions |
| 105 | 5 * General requirements for testing me equipment |
| 106 | 6 * Classification of me equipment and me systems 7 Me equipment identification, marking and documents 7.1 * Usability of the accompanying documents Figures Figure 1 – Small finger probe Ø 5,6 |
| 107 | 7.2 * Additional requirements for marking of IP classification 7.3 Accompanying documents 7.3.1 Contact information 7.3.2 Lay operator briefing information |
| 108 | 7.4 Instructions for use 7.4.1 Additional requirements for warning and safety notices 7.4.2 * Additional requirements for an electrical power source |
| 109 | 7.4.3 Additional requirements for me equipment description 7.4.4 Additional requirements for me equipment start-up procedure 7.4.5 Additional requirements for operating instructions |
| 110 | 7.4.6 Additional requirements for me equipment messages 7.4.7 * Additional requirements for cleaning, disinfection and sterilization 7.4.8 Additional requirements for maintenance 7.4.9 Additional requirements for environmental protection |
| 111 | 7.4.10 Additional requirements for me equipment and me systems 7.5 Technical description 7.5.1 Permanently installed class i me equipment 7.5.2 Additional requirements for professional hygienic maintenance 8 Protection against excessive temperatures and other hazards 8.1 * Additional requirements for cleaning, disinfection of me equipment and me systems |
| 112 | 8.2 * Additional requirements for sterilization of me equipment and me systems 8.3 Additional requirements for ingress of water or particulate matter into me equipment and me systems 8.3.1 * Ingress of water or particulate matter into me equipment 8.3.2 * Ingress of water or particulate matter into me systems 8.4 Additional requirements for interruption of the power supply/supply mains to me equipment and me system |
| 113 | 8.5 Additional requirements for an internal electrical power source 8.5.1 * Indication of state |
| 114 | 8.5.2 Accessibility of small internal electrical power sources 9 Accuracy of controls and instruments and protection against hazardous outputs 10 Construction of me equipment 10.1 * Additional requirements for mechanical strength 10.1.1 General requirements for mechanical strength |
| 115 | Tables Table 1 – Mechanical strength test applicability, non-transit-operable |
| 116 | 10.1.2 * Requirements for mechanical strength for non-transit-operable me equipment Table 2 – Mechanical strength test applicability, transit-operable |
| 117 | 10.1.3 * Requirements for mechanical strength for transit-operable me equipment |
| 118 | 10.2 Additional requirements for actuating parts of controls of me equipment |
| 119 | 11 * Protection against strangulation or asphyxiation 12 Additional requirements for electromagnetic emissions of me equipment and me systems 13 Additional requirements for alarm systems of me equipment and me systems 13.1 * Additional requirement for generation of alarm signals 13.2 * Additional requirement for alarm signal volume |
| 120 | Annex A (informative) General guidance and rationale |
| 125 | Figure A.1 – Saturation water vapour pressure as function of temperature |
| 126 | Table A.1 – Saturation water vapour pressure as function of temperature |
| 135 | Table A.2 – Summary by use of home healthcare environment me equipment enclosure ingress of water and particulate matter requirements |
| 136 | Table A.3 – Qualitative assessment of home healthcare environment me equipment subjected to shock and vibration |
| 140 | Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems Table B.1 – Marking on the outside of me equipment, me systems or their parts Table B.2 – Accompanying documents, general |
| 141 | Table B.3 – Accompanying documents, instructions for use |
| 142 | Table B.4 – Accompanying documents, technical description |
| 143 | Annex C (informative) Symbols on marking Table C.1 – General symbols (1 of 2) |
| 145 | Bibliography |
| 147 | Index of defined terms used in this collateral standard |
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