EN 60601-1-12:2015

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Classification of ME EQUIPMENT and ME SYSTEMS
6 ME EQUIPMENT identification, marking and documents
7 Protection against electrical HAZARDS from ME EQUIPMENT
8 Protection against excessive temperatures and other HAZARDS
9 Accuracy of controls and instruments and protection against
   hazardous outputs
10 Construction of ME EQUIPMENT
11 Additional requirements for electromagnetic compatibility of
   ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling requirements
        for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
          international publications with their
          corresponding European publications
Annex ZZA (informative) - Coverage of Essential
          Requirements of EU Directives
Annex ZZB (informative) - Coverage of
          Essential Requirements of EU Directives

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.