This standard applies to the safety and essential performance of medical electrical equipment and medical electrical systems, which are intended by the manufacturer for use in home care applications usually without continual professional supervision and temporarily in the clinical environment. These medical electrical equipment and medical electrical systems will frequently be used in locations where driving power and safety means of the electrical installation is not reliable. These medical electrical equipment and medical electrical systems will often be supervised by non-healthcare personnel with different levels of training<\/p>\n
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| 1<\/td>\n | ANSI\/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD), MEDICAL ELECTRICAL EQUIPMENT \u2014 Part 1-11: General requirements for basic safety and essential performance \u2013 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Background of ANSI\/AAMI adoption of IEC 60601-1-11:2015 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | U.S. Deviations to IEC 60601-1-11:2015 <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1 <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 1.3.2 Particular standards 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 4.2.2 * Environmental conditions of transport and storage between uses <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 4.2.3 * Environmental operating conditions 4.2.3.1 Continuous operating conditions <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 4.2.3.2 * Environmental shock to transit-operable me equipment 5 * General requirements for testing me equipment <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Figure 1 \u2013 Small finger probe \u00d8 5.6 6 * Classification of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7 Me equipment identification, marking and documents 7.1 * Usability of the accompanying documents 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 <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 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 7.4.3 Additional requirements for me equipment description <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.4.4 Additional requirements for me equipment start-up procedure 7.4.5 Additional requirements for operating instructions 7.4.6 Additional requirements for me equipment messages 7.4.7 * Additional requirements for cleaning, disinfection and sterilization <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 7.4.8 Additional requirements for maintenance 7.4.9 Additional requirements for environmental protection 7.4.10 Additional requirements for me equipment and me systems 7.5 Technical description 7.5.1 Permanently installed class i me equipment <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 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 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 <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 8.4 Additional requirements for interruption of the power supply\/supply mains to me equipment and me system 8.5 Additional requirements for an internal electrical power source 8.5.1 * Indication of state <\/td>\n<\/tr>\n | ||||||
| 33<\/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 equipment 10.1 * Additional requirements for mechanical strength 10.1.1 General requirements for mechanical strength <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Table 1 \u2013 Mechanical strength test applicability, non-TRANSIT-OPERABLE <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 10.1.2 * Requirements for mechanical strength for non-transit-operable me equipment <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 10.1.3 * Requirements for mechanical strength for transit-operable me equipment <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 10.2 Additional requirements for actuating parts of controls of me equipment <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex A: General guidance and rationale A.1 General guidance <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Figure A.1 \u2013 Saturation water vapor pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Table A.1 \u2013 Saturation water vapor pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Table A.2 \u2013 Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress ofwater and particulate matter requirements <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Table A.3 \u2013 Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shockand vibration <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Annex B: Guide to marking and labelling requirements for me equipment and me systems B.1 Marking on the outside of me equipment, me systems or their parts Table B.1 \u2013 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts B.2 Accompanying documents, general Table B.2 \u2013 ACCOMPANYING DOCUMENTS, general <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | B.3 Accompanying documents, instructions for use Table B.3 \u2013 ACCOMPANYING DOCUMENTS, instructions for use <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | B.4 Accompanying documents, technical description Table B.4 \u2013 ACCOMPANYING DOCUMENTS, technical description <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | Annex C: Symbols on marking Table C.1 \u2013 General symbols <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | Index of defined terms used in this collateral standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD) – MEDICAL ELECTRICAL EQUIPMENT – Part 1-11: General requirements for basic safety and essential performance \u2013 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/b><\/p>\n |