The fourth edition of IEC 60601-1-2 was published on 25 February 2014. It constitutes a significant change in the standard from the third edition of the standard which was published back in 2007.
From the EMC experts I work with I have heard that some of the test levels have changed significantly and so that will could impact your designs for future compliance testing. So, a question that is currently unanswered is when will this standard be transitioned into national standards for different countries around the world. The standard text suggests at least a three year transition period. It will be up to the different national standards development organizations (SDO’s) and the regulatory bodies around the world to make those determinations. We will be keeping close tabs on this and reporting any information we hear more.
The foreword of the standard mentions a list of most significant changes from the third edition to the current fourth edition of the standard which include:
– specification of IMMUNITY TEST LEVELS according to the environments of INTENDED USE, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the HOME HEALTHCARE ENVIRONMENT and SPECIAL ENVIRONMENTS;
– specification of tests and test levels to improve the safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS when PORTABLE RF communications equipment is used closer to the MEDICAL ELECTRICAL EQUIPMENT than was recommended based on the IMMUNITY TEST LEVELS that were specified in the third edition;
– specification of IMMUNITY tests and IMMUNITY TEST LEVELS according to the PORTS of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM;
– specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE, resulting in some IMMUNITY TEST LEVELS that are higher than in the previous edition; and
– better harmonization with the RISK concepts of BASIC SAFETY and ESSENTIAL PERFORMANCE, including deletion of the defined term “life-supporting”;
and the following additions:
– guidance for determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS;
– guidance for adjustment of IMMUNITY TEST LEVELS when special considerations of mitigations or INTENDED USE are applicable;
– guidance on RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES; and
– guidance on identification of IMMUNITY pass/fail criteria.
We will send out a more detailed post on this topic in the future. Keep an eye out for an update post on this standard.