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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 8<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope, object and related standards 1.1 *\u00a0Scope 1.2 Object 1.3 Related standards <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4 General requirements 4.1 *\u00a0Additional requirements for supply mains for me\u00a0equipment and me\u00a0systems 4.2 Environmental conditions for me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5 *\u00a0General requirements for testing me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6 *\u00a0Classification of me\u00a0equipment and me\u00a0systems 7 Me\u00a0equipment identification, marking and documents 7.1 *\u00a0Usability of the accompanying documents Figure 1 \u2013 Small finger probe diameter 5,6 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 7.2 *\u00a0Additional requirements for marking of IP classification 7.3 Accompanying documents <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 7.4 Instructions for use <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 7.5 Technical description 8 Protection against excessive temperatures and other hazards 8.1 *\u00a0Additional requirements for cleaning, disinfection of me\u00a0equipment and me\u00a0systems 8.2 *\u00a0Additional requirements for sterilization of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 8.3 Additional requirements for ingress of water or particulate matter into me\u00a0equipment and me\u00a0systems 8.4 Additional requirements for interruption of the power supply\/supply mains to me\u00a0equipment and me\u00a0system <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 9 Accuracy of controls and instruments and protection against hazardous outputs 10 Construction of me\u00a0equipment 10.1 *\u00a0Additional requirements for mechanical strength <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Tables Table 1 \u2013 Mechanical strength test applicability, non-transit-operable <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Table 2 \u2013 Mechanical strength test applicability, transit-operable <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 10.2 *\u00a0Additional requirements for an internal electrical power source <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 10.3 Additional requirements for actuating parts of controls of me\u00a0equipment 11 *\u00a0Protection against strangulation or asphyxiation 12 Additional requirements for electromagnetic compatibility of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 12.1 Emissions classification 12.2 Protection of the public mains network 12.3 *\u00a0Additional technical description requirements applicable to me\u00a0equipment and me\u00a0systems 12.4 *\u00a0Additional requirements applicable to me\u00a0equipment and me\u00a0systems specified for use only in a shielded location 12.5 *\u00a0Additional requirements for electrostatic discharge (esd) tests 13 Additional requirements for alarm systems of me\u00a0equipment and me\u00a0systems 13.1 *\u00a0Additional requirement for generation of alarm signals <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 13.2 *\u00a0Additional requirement for alarm signal volume <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Table A.1 \u2013 Summary by use of home healthcare environment me\u00a0equipment enclosure ingress of water and particulate matter requirements <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Table A.2 \u2013 Qualitative assessment of home healthcare environment me\u00a0equipment subjected to shock and vibration <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems Table\u00a0B.1 \u2013 Marking on the outside of me\u00a0equipment, me\u00a0systems or their parts Table\u00a0B.2 \u2013 Accompanying documents, general <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Table\u00a0B.3 \u2013 Accompanying documents, instructions for use <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | Table\u00a0B.4 \u2013 Accompanying documents, instructions for use (continued) Table\u00a0B.5 \u2013 Accompanying documents, technical description <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Annex C (informative) Symbols on marking Table C\u00a01\u00a0\u2013 General symbols <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Index of defined terms used in this collateral standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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<\/b><\/p>\n |