IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | Foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Annex ZA (normative) Normative references to international publications with their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Annex ZZA (informative) Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Annex ZZB (informative) Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 1 Scope, object and related standards 1.1 *\u00a0Scope 1.2 *\u00a0Object <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 1.3 Related standards 1.3.1 IEC\u00a060601-1 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 *\u00a0Additional requirements for supply mains for me\u00a0equipment and me\u00a0systems 4.2 *\u00a0Environmental conditions for me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.2.1 *\u00a0Environmental conditions of transport and storage between uses <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 4.2.2 *\u00a0Environmental operating conditions <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5 *\u00a0Classification of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6 Me\u00a0equipment identification, marking and documents 6.1 *\u00a0Additional requirements for legibility of markings 6.2 *\u00a0Additional requirements for marking of IP classification 6.3 * Instructions for use 6.3.1 Additional general requirements <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.3.2 *\u00a0Additional requirements for an electrical power source 6.3.3 Additional requirements for me\u00a0equipment start-up procedure <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 6.3.4 *\u00a0Additional requirements for operating instructions 6.3.5 Additional requirements for me\u00a0equipment messages 6.4 Technical description \u2013 fixed or permanently installed class\u00a0i me\u00a0equipment 7 *\u00a0Protection against electrical hazards from me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 8 Protection against excessive temperatures and other hazards 8.1 Additional requirements for ingress of water or particulate matter into me\u00a0equipment and me\u00a0systems 8.1.1 *\u00a0Ingress of water or particulate matter into me\u00a0equipment 8.1.2 *\u00a0Ingress of water or particulate matter into me\u00a0systems 8.2 Additional requirements for interruption of the power supply to me\u00a0equipment and me\u00a0system <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 8.3 *\u00a0Additional requirements for internal electrical power source for me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 9 *\u00a0Accuracy of controls and instruments and protection against hazardous outputs 10 Construction of me\u00a0equipment 10.1 *\u00a0Additional requirements for mechanical strength of me\u00a0equipment intended for the ems environment 10.1.1 General requirements for mechanical strength <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 10.1.2 *\u00a0Requirements for mechanical strength for fixed or permanently installed me\u00a0equipment intended for use in a road ambulance Tables Table\u00a01 \u2013 Mechanical strength test applicability <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 10.1.3 *\u00a0Requirements for mechanical strength for transportable me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 10.1.4 *\u00a0Requirements for mechanical strength for me\u00a0equipment intended for airborne use <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 10.2 Requirements for mounting of me\u00a0equipment 11 Additional requirements for electromagnetic compatibility of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex A (informative) General guidance and rationale A.1 General guidance <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Figures Figure\u00a0A.1\u00a0\u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Table\u00a0A.1\u00a0\u2013 Saturation water vapour pressure as function of temperature <\/td>\n<\/tr>\n | ||||||
| 49<\/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\u00a0equipment, me\u00a0systems or their parts B.2 Accompanying documents, instructions for use Table\u00a0B.1 \u2013 Marking on the outside of me\u00a0equipment, me\u00a0systems or their parts Table B.2 \u2013 Accompanying documents, instructions for use <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | B.3 Accompanying documents, technical description Table\u00a0B.3 \u2013 Accompanying documents, technical description <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Annex C (informative) Symbols on marking Table C.1 \u2013 General symbols <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 55<\/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 intended for use in the emergency medical services environment<\/b><\/p>\n |