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 \u00b0C; – 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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | Foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Annex ZA (normative) Normative references to international publications with their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 1 Scope, object and related standards 1.1 *\u00a0Scope 1.2 Object 1.3 Related standards 1.3.1 IEC\u00a060601-1 <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 1.3.2 Particular standards 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4 General requirements 4.1 *\u00a0Additional requirements for supply mains for me\u00a0equipment and me\u00a0systems 4.2 *\u00a0Environmental conditions for me\u00a0equipment 4.2.1 General <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 4.2.2 *\u00a0Environmental conditions of transport and storage between uses <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.2.3 *\u00a0Environmental operating conditions <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5 *\u00a0General requirements for testing me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6 *\u00a0Classification of me\u00a0equipment and me\u00a0systems 7 Me\u00a0equipment identification, marking and documents 7.1 *\u00a0Usability of the accompanying documents Figures Figure\u00a01\u00a0\u2013 Small finger probe \u00d8 5,6 <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.2 *\u00a0Additional requirements for marking of IP classification 7.3 Accompanying documents 7.3.1 Contact information 7.3.2 Lay operator briefing information <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7.4 Instructions for use 7.4.1 Additional requirements for warning and safety notices 7.4.2 *\u00a0Additional requirements for an electrical power source <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7.4.3 Additional requirements for me\u00a0equipment description 7.4.4 Additional requirements for me\u00a0equipment start-up procedure 7.4.5 Additional requirements for operating instructions <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.4.6 Additional requirements for me\u00a0equipment messages 7.4.7 *\u00a0Additional requirements for cleaning, disinfection and sterilization 7.4.8 Additional requirements for maintenance 7.4.9 Additional requirements for environmental protection <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.4.10 Additional requirements for me\u00a0equipment and me\u00a0systems 7.5 Technical description 7.5.1 Permanently installed class\u00a0i me\u00a0equipment 7.5.2 Additional requirements for professional hygienic maintenance 8 Protection against excessive temperatures and other hazards 8.1 *\u00a0Additional requirements for cleaning, disinfection of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 8.2 *\u00a0Additional requirements for sterilization of me\u00a0equipment and me\u00a0systems 8.3 Additional requirements for ingress of water or particulate matter into me\u00a0equipment and me\u00a0systems 8.3.1 *\u00a0Ingress of water or particulate matter into me\u00a0equipment 8.3.2 *\u00a0Ingress of water or particulate matter into me\u00a0systems 8.4 Additional requirements for interruption of the power supply\/supply mains to me\u00a0equipment and me\u00a0system <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 8.5 Additional requirements for an internal electrical power source 8.5.1 *\u00a0Indication of state <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 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\u00a0equipment 10.1 *\u00a0Additional requirements for mechanical strength 10.1.1 General requirements for mechanical strength <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Tables Table\u00a01\u00a0\u2013 Mechanical strength test applicability, non-transit-operable <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 10.1.2 *\u00a0Requirements for mechanical strength for non-transit-operable me\u00a0equipment Table\u00a02 \u2013 Mechanical strength test applicability, transit-operable <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 10.1.3 *\u00a0Requirements for mechanical strength for transit-operable me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 10.2 Additional requirements for actuating parts of controls of me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 11 *\u00a0Protection against strangulation or asphyxiation 12 Additional requirements for electromagnetic emissions of me\u00a0equipment and me\u00a0systems 13 Additional requirements for alarm systems of me\u00a0equipment and me\u00a0systems 13.1 *\u00a0Additional requirement for generation of alarm signals 13.2 *\u00a0Additional requirement for alarm signal volume <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Figure\u00a0A.1\u00a0\u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Table\u00a0A.1\u00a0\u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Table\u00a0A.2\u00a0\u2013 Summary by use of home healthcare environment me\u00a0equipment enclosure ingress of water and particulate matter requirements <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Table\u00a0A.3\u00a0\u2013 Qualitative assessment of home healthcare environment me\u00a0equipment subjected to shock and vibration <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems Table\u00a0B.1\u00a0\u2013 Marking on the outside of me\u00a0equipment, me\u00a0systems or their parts Table\u00a0B.2\u00a0\u2013 Accompanying documents, general <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Table\u00a0B.3\u00a0\u2013 Accompanying documents, instructions for use <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | Table\u00a0B.4\u00a0\u2013 Accompanying documents, technical description <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex C (informative) Symbols on marking Table\u00a0C.1\u00a0\u2013 General symbols (1 of 2) <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 65<\/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 |