EVS-EN 60601-1-11:2015/A1:2021

EN 60601-1-11 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN 60601-1-11:2015/A1:2021 modifies the European standard EN 60601-1-11.

Since the publication of the main text, the IEC Subcommittee has been collecting issues from a variety of sources including comments from national committees. The subcommittee initiated a process to identify high-priority issues that need to be considered in an amendment and should not wait until the third edition. These issues are covered in this amendment.