Applies to basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended for use by their manufacturers for use in the EMS environment. Does not apply to equipment and systems intended for use solely in home healthcare environment or professional healthcare facilities.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/IEC 60601-1-12:2016; Medical electrical \nequipment\u2014Part 1-12: General requirements for basic safety and essential performance\u2014Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services 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 | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Background on AAMI adoption of IEC 60601-1-12:2014 <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 1 Scope, object and related standards 1.1 * Scope 1.2 * Object <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 1.3 Related standards 1.3.1 IEC 60601-1 1.3.2 Particular standards 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 18<\/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 * Environmental conditions of transport and storage between uses <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.2.2 * Environmental operating conditions 4.2.2.1 Continuous operating conditions <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.2.2.2 * Transient operating conditions <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5 * Classification of me equipment and me systems 6 Me equipment identification, marking and documents 6.1 * Additional requirements for legibility of markings 6.2 * Additional requirements for marking of IP classification <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6.3 * Instructions for use 6.3.1 Additional general requirements 6.3.2 * Additional requirements for an electrical power source 6.3.3 Additional requirements for me equipment start-up procedure <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.3.4 * Additional requirements for operating instructions 6.3.5 Additional requirements for me equipment messages 6.4 Technical description \u2013 fixed or permanently installed class i me equipment 7 * Protection against electrical hazards from me equipment 8 Protection against excessive temperatures and other hazards 8.1 Additional requirements for ingress of water or particulate matter into me equipment and me systems 8.1.1 * Ingress of water or particulate matter into me equipment <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 8.1.2 * Ingress of water or particulate matter into me systems 8.2 Additional requirements for interruption of the power supply to me equipment and me system <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 8.3 * Additional requirements for internal electrical power source for me equipment 9 * Accuracy of controls and instruments and protection against hazardous outputs 10 Construction of me equipment 10.1 * Additional requirements for mechanical strength of me equipment intended for the ems environment 10.1.1 General requirements for mechanical strength <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 10.1.2 * Requirements for mechanical strength for fixed or permanently installed me equipment intended for use in a road ambulance <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 10.1.3 * Requirements for mechanical strength for transportable me equipment <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 10.1.4 * Requirements for mechanical strength for me equipment intended for airborne use <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 10.2 Requirements for mounting of me equipment 11 Additional requirements for electromagnetic compatibility of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex A (informative) General guidance and rationale A.1 General guidance <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Figure A.1 \u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Table A.1 \u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex B (informative) 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, instructions for use Table B.2 \u2013 ACCOMPANYING DOCUMENTS, instructions for use (1 of 2) <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | B.3 Accompanying documents, technical description <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Table B.3 \u2013 ACCOMPANYING DOCUMENTS, technical description Annex C (informative) Symbols on marking Table C.1 \u2013 General symbols <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Index of defined terms used in this collateral standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/IEC 60601-1-12:2016 – Medical electrical equipment-Part 1-12: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.<\/b><\/p>\n |