scope:

This clause of part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: This part 2 applies to automatic and semi-automatic laboratory equipment for analysis and other purposes. Automatic and semi-automatic laboratory equipment consists of instruments or systems for measuring or modifying one or more characteristics or parameters of samples, performing the complete process or parts of the process without manual intervention. Equipment forming part of such a system is within the scope of this standard. Examples of equipment within the scope of this standard include: · analytical equipment; · automatic sampler (pipettor, aliquoter); · equipment for sample replication and amplification. NOTE 1 In the case of analytical equipment the complete process usually includes the following steps: · taking a specific quantity of the sample; · preparing the sample by chemical, thermal, mechanical or other means; · measurement; · display, transmission or printing of the results of measurement. NOTE 2 If 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 standard, it will also need to meet the requirements of those other parts 2 standards. 1.1.2 Equipment excluded from scope Addition: Add the following item aa) IEC 61010-2-101 (IVD Equipment)