What is meant by installation, commissioning, validation, periodic testing and maintenance?

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What is meant by installation, commissioning, validation, periodic testing and maintenance?

For decontamination equipment as used in dental practices, this is currently under review but you can access archived explanation documents here.

Installation: the process of putting a piece of equipment or machinery in place and making it ready for use. This includes carrying out a series of installation checks and tests and is usually carried out by the equipment supplier. Installation forms part of the commissioning process.

Commissioning: the process of establishing and documenting that a piece of equipment has been provided and installed in accordance with the equipment specifications and that it functions within predetermined limits when the operating instructions are followed. It includes a number of tests, carried out by both the equipment supplier and a qualified Test Person.

Validation: a documented procedure for gathering, recording and interpreting data to show that the process is consistently complying with a predetermined specification. Validation is required for new equipment at installation and annually thereafter. It includes all of the tests carried during commissioning plus additional tests carried out by a Test Person, the results of which are verified by an Authorizing Engineer (Decontamination) [AE(D)]. In due course, it is expected that there will be sufficient AE(D)s available for this.

Periodic Testing: decontamination equipment needs to be tested regularly to ensure that it continues to perform satisfactorily. Some tests are carried out each day, others weekly with additional more extensive and elaborate tests performed quarterly and/or annually according to manufacturer instructions. Collectively this is called periodic testing. Quarterly and annual testing is carried out by a qualified Test Person.

Maintenance: work carried out regularly to keep the equipment in good working order. This is carried out by a qualified Maintenance Person and should follow a planned program as specified by the equipment manufacturer.