BS EN 60601-1-11:2010
$198.66
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 | 2010 | 62 |
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. The contents of the corrigendum of April 2011 have been included in this copy.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 8 | English CONTENTS |
| 10 | INTRODUCTION |
| 11 | 1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards |
| 12 | 2 Normative references 3 Terms and definitions |
| 14 | 4 General requirements 4.1 * Additional requirements for supply mains for me equipment and me systems 4.2 Environmental conditions for me equipment |
| 17 | 5 * General requirements for testing me equipment |
| 18 | 6 * Classification of me equipment and me systems 7 Me equipment identification, marking and documents 7.1 * Usability of the accompanying documents Figure 1 – Small finger probe diameter 5,6 |
| 19 | 7.2 * Additional requirements for marking of IP classification 7.3 Accompanying documents |
| 20 | 7.4 Instructions for use |
| 23 | 7.5 Technical description 8 Protection against excessive temperatures and other hazards 8.1 * Additional requirements for cleaning, disinfection of me equipment and me systems 8.2 * Additional requirements for sterilization of me equipment and me systems |
| 24 | 8.3 Additional requirements for ingress of water or particulate matter into me equipment and me systems 8.4 Additional requirements for interruption of the power supply/supply mains to me equipment and me system |
| 25 | 9 Accuracy of controls and instruments and protection against hazardous outputs 10 Construction of me equipment 10.1 * Additional requirements for mechanical strength |
| 26 | Tables Table 1 – Mechanical strength test applicability, non-transit-operable |
| 27 | Table 2 – Mechanical strength test applicability, transit-operable |
| 29 | 10.2 * Additional requirements for an internal electrical power source |
| 30 | 10.3 Additional requirements for actuating parts of controls of me equipment 11 * Protection against strangulation or asphyxiation 12 Additional requirements for electromagnetic compatibility of me equipment and me systems |
| 31 | 12.1 Emissions classification 12.2 Protection of the public mains network 12.3 * Additional technical description requirements applicable to me equipment and me systems 12.4 * Additional requirements applicable to me equipment and me systems specified for use only in a shielded location 12.5 * Additional requirements for electrostatic discharge (esd) tests 13 Additional requirements for alarm systems of me equipment and me systems 13.1 * Additional requirement for generation of alarm signals |
| 32 | 13.2 * Additional requirement for alarm signal volume |
| 33 | Annex A (informative) General guidance and rationale |
| 45 | Table A.1 – Summary by use of home healthcare environment me equipment enclosure ingress of water and particulate matter requirements |
| 46 | Table A.2 – Qualitative assessment of home healthcare environment me equipment subjected to shock and vibration |
| 52 | 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 |
| 54 | Table B.3 – Accompanying documents, instructions for use |
| 55 | Table B.4 – Accompanying documents, instructions for use (continued) Table B.5 – Accompanying documents, technical description |
| 56 | Annex C (informative) Symbols on marking Table C 1 – General symbols |
| 57 | Bibliography |
| 59 | Index of defined terms used in this collateral standard |
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