Iec 60601 1 standard pdf

The iec 60601 was first published in 1977, then referred to as iec 601, and handles the electrical safety of both mechanical and electrical issues. Iec6060116 medical electrical equipment part 1 6 general requirements for basic safety and essential performance collateral standard usability iec6060116 edition 3. Or download the pdf of the directive or of the official journal for free. Common aspects of electrical equipment used in medical practice, of iec technical committee 62. This standard applies to the safety of medical electrical equipment as defined in subclause 2.

This collateral standard to iec 606011 specifies general requirements and tests for basic safety and essential. Programmable electrical medical systems consolidated edition. The changes made by these amendments are consolidated into the text of es606011 and the amendments are included at the end of the pdf. Note 1 this interpretation sheet is intended to be used with both edition 3.

Iecen 606011 basic safety and essential performance of. International standards for all electrical, electronic and related technologies. Food and drug administration scheduled to require evidence of compliance with the. This fourth edition cancels and replaces the third edition of iec 6060112, and. This does not replace the standards, and a purchased copy of the iec and national standards should also be used. Iec 606011 and its relevance to power supplies the iec 606011 standard has a. New medical emc standard iec 6060112 4th edition the 606011 collateral standard for medical emc is 6060112, presently the 3rd edition of the standard is in force.

Iec 606011 medical design standards for power supplies cui inc. Some major import countries for such equipment have started to enforce the. International standard iec 6060112 has been prepared by subcommittee 62a. It also includes information and interpretations for. They are in addition to the requirements of the general standard iec 606011 and serve as the basis for particular standards. The evaluation package is a summary of the iec 606011. Risk resulting from applying the requirement of the standard.

General requirements for basic safety and essential performance collateral. Iec 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. Iec 606011 does not apply to medical gas pipeline systems covered by. Iec 606011 medical design standards for power supplies. Missing page numbers correspond to the frenchlanguage pages. Iec 606011 is an international standard and applies to the basic safety and essential performance of electrical medical equipment and electrical medical systems, referenced as me equipment and me. Although this standard is primarily concerned with. The following is tool for evaluating medical equipment labeling and user manuals to the requirements of the 60601 1 standards. Note 2 an example of an analysis that demonstrates an adequately low probability of occurrence of harm is shown below. The primary standard the primary standard governing medical device design is formally known as iec 60601 1 medical electrical equipment part 1. Standard references iec 6060112, 3rdedition undated iec 6060112, 4th edition dated undated reference the current version in publication, no grandfathering. Iec 606011 medical electrical equipment part 1 tdklambda emea.

This third edition constitutes a collateral standard to iec 606011. A particular standard takes priority over this general standard. General requirements for safety collateral standard. General requirements for basic safety and essential performance collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home. The fourth edition iecen 6060112 4 th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. General requirements for basic safety and essential. The primary standard governing medical device design is formally known as iec 606011. The evaluation package is a summary of the iec 60601 1.