Standards Development

Scope

This clause of Part 1 is applicable except as follows:

1.1.1 Equipment included in scope

Replacement:

Replace the text, except the first paragraph, by the following new text:

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 document.

Examples of equipment within the scope of this document 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 documents of IEC 61010 as well as within the scope of this document, consideration is given to those other Part 2 documents.

1.1.2 Equipment excluded from scope

Addition:

Add the following new item:

aa)  IEC 61010-2-101 (in vitro diagnostic (IVD) equipment).

1.2 Object

1.2.1 Aspects included in scope

Addition:

Add the following new items:

aa)  biohazards;

bb)  hazardous chemical substances.

1.2.2 Aspects excluded from scope

Addition:

Add the following new item and note:

aa)  handling or manipulation of material outside the equipment.

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