IEC 60601-1-2:2007

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT and ME SYSTEMS identification,
  marking and documents
6 Documentation of the tests
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT
  and ME SYSTEMS
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT
  and ME SYSTEMS
9 Test report
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) - Guidance in classification according
        to CISPR 11
Annex D (informative) - Guidance in the application of
        IEC 60601-1-2 to particular standards
Annex E (informative) - Determination of IMMUNITY TEST LEVELS
        for SPECIAL ENVIRONMENTS
Annex F (informative) - RISK MANAGEMENT for BASIC SAFETY and
        ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC
        DISTURBANCES
Annex G (informative) - Guidance: Test plan
Annex H (informative) - PATIENT-coupled cables EMISSIONS
Annex I (informative) - Identification of IMMUNITY pass/fail
        criteria
Bibliography
Index of defined terms used in this collateral standard

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.The contents of the interpretation sheet of March 2010 have been included in this copy.