BS EN 60601-1-12:2015
$198.66
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
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 58 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Foreword Endorsement notice |
| 5 | Annex ZA (normative) Normative references to international publications with their corresponding European publications |
| 7 | Annex ZZA (informative) Coverage of Essential Requirements of EU Directives |
| 8 | Annex ZZB (informative) Coverage of Essential Requirements of EU Directives |
| 9 | English CONTENTS |
| 11 | FOREWORD |
| 14 | INTRODUCTION |
| 15 | 1 Scope, object and related standards 1.1 * Scope 1.2 * Object |
| 16 | 1.3 Related standards 1.3.1 IEC 60601-1 1.3.2 Particular standards 2 Normative references |
| 17 | 3 Terms and definitions |
| 18 | 4 General requirements 4.1 * Additional requirements for supply mains for me equipment and me systems 4.2 * Environmental conditions for me equipment |
| 19 | 4.2.1 * Environmental conditions of transport and storage between uses |
| 20 | 4.2.2 * Environmental operating conditions |
| 22 | 5 * Classification of me equipment and me systems |
| 23 | 6 Me equipment identification, marking and documents 6.1 * Additional requirements for legibility of markings 6.2 * Additional requirements for marking of IP classification 6.3 * Instructions for use 6.3.1 Additional general requirements |
| 24 | 6.3.2 * Additional requirements for an electrical power source 6.3.3 Additional requirements for me equipment start-up procedure |
| 25 | 6.3.4 * Additional requirements for operating instructions 6.3.5 Additional requirements for me equipment messages 6.4 Technical description – fixed or permanently installed class i me equipment 7 * Protection against electrical hazards from me equipment |
| 26 | 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 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 |
| 27 | 8.3 * Additional requirements for internal electrical power source for me equipment |
| 28 | 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 |
| 29 | 10.1.2 * Requirements for mechanical strength for fixed or permanently installed me equipment intended for use in a road ambulance Tables Table 1 – Mechanical strength test applicability |
| 30 | 10.1.3 * Requirements for mechanical strength for transportable me equipment |
| 31 | 10.1.4 * Requirements for mechanical strength for me equipment intended for airborne use |
| 32 | 10.2 Requirements for mounting of me equipment 11 Additional requirements for electromagnetic compatibility of me equipment and me systems |
| 33 | Annex A (informative) General guidance and rationale A.1 General guidance |
| 35 | A.2 Rationale for particular clauses and subclauses |
| 38 | Figures Figure A.1 – Saturation water vapour pressure as function of temperature |
| 39 | Table A.1 – Saturation water vapour pressure as function of temperature |
| 49 | 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 B.2 Accompanying documents, instructions for use Table B.1 – Marking on the outside of me equipment, me systems or their parts Table B.2 – Accompanying documents, instructions for use |
| 50 | B.3 Accompanying documents, technical description Table B.3 – Accompanying documents, technical description |
| 51 | Annex C (informative) Symbols on marking Table C.1 – General symbols |
| 53 | Bibliography |
| 55 | Index of defined terms used in this collateral standard |
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BS EN 60601-1-12:2015+A1:2020
Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Requirements…
