CEI EN 61010-2-081 PDF

Equipment included in scope

This part of IEC 61010 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, considerations have to be given to those other part 2 standards.

Equipment excluded from scope

aa) IEC 61010-2-101 (IVD Equipment)

Object

Aspects included in scope

aa) biohazards;

bb) hazardous chemical substances.

Aspects excluded from scope

cc) handling or manipulation of material outside the equipment.

NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant standards.