EN IEC 60601-2-2:2018

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME
       EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures
       and other HAZARDS
201.12 Accuracy of controls and instruments and
       protection against hazardous
       outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 * ELECTROMAGNETIC DISTURBANCES - Requirements and tests
208 General requirements, tests and guidance for alarm systems
    in medical electrical equipment and medical electrical systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - ELECTROMAGNETIC DISTURBANCES
         created by HF SURGICAL EQUIPMENT
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications

NEW!IEC 60601-2-2:2017 is available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.

HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.

The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories.

This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:

- refinement and additions to the defined terms;

- additional separation of the requirements for HF surgical equipment and HF surgical accessories;

- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;

- new requirements for devices that have or use a high current mode.