1 Modifications to 1.1.1, "Equipment included in scope" Replace the title as follows: "1.1.1 General" Replace the second paragraph with the following: "This part of IEC 61010 provides particular safety requirements to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It is intended to be used in conjunction of the manufacturer s risk management but not to replace it. NOTE 1 A good design practice of an equipment starts from the beginning with a risk management process according to ISO 14971, which provides requirement and guidance for a comprehensive risk management process and identifies hazards and risks related with the equipment." Replace the note with the following: "NOTE 2 A system, as specified by its manufacturer, is a combination of items of equipment, at least one of these is inter-connected to another item. In the following text the term equipment is used for single equipment and systems. It is possible that all or part of the equipment falls within the scope of one or more other Part 2 standards of IEC 61010 as well as within the scope of this document. In that case, the requirements of those other Part 2 standards will also apply." 2 Modifications to 1.1.2, "Equipment excluded from scope" Replace the title as follows: "1.1.2 Exclusions from the scope" 3 Modifications to 1.2.1, "Aspects included in scope" Replace the first paragraph with the following: The purpose of the requirements of this document is to ensure that HAZARDS to the OPERATOR, the SERVICE PERSONNEL and the surrounding area are reduced to a tolerable level." Add the following item to the list: "cc) any other energy sources (see Clause 101)" 4 Modifications to 1.2.2, "Aspects excluded from scope" Delete items b) and c).