Labelling and certification of laboratory centrifuges, what are they and what is the difference?

For some time now, centrifuges, like other laboratory equipment, must be accompanied by specific certificates and labels depending on the regulations and their use in the laboratory.

Given the confusion sometimes generated by compliance with the regulations and directives that define this type of labelling, from Ortoalresa, we want to offer some basic guidelines for the appropriate choice of centrifuges.

This brings us to the first basic question…

Which markings are required?

CE marking of conformity. It is mandatory to be able to market in Europe indicating that the product is manufactured in compliance with the mandatory legislation on European essential requirements. It is found both on the characteristics label of the centrifuge and in the declaration of conformity issued by the manufacturer and accompanying the equipment.

Some applications that require only this type of marking:

• Applications in the industrial field: oil, power plants, food … any type of laboratory that works with non-clinical samples.
• Applications in veterinary laboratories, food quality control, biotechnology in plants and animals, pharmacy, investigation of samples of non-human origin, education, etc.

Regarding the selection of laboratory centrifuges, we must take into account the application and the requirements generated from it, since they may lead us to require other types of certifications, such as the CE marking of medical devices and the CE marking – IVD (in vitro diagnostic medical device).

This type of labelling and certifications is needed only for applications related to samples from human beings.

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But, what is the difference between centrifuges with CE marking for medical devices and CE – IVD?

By definition in the Regulations and as a general concept:

• Healthcare products: are those products intended to be used with samples of human origin for specific purposes of diagnosis, research, modification of a physiological process or regulation of conception. As far as centrifuges are concerned, it will be the one destined to process blood and / or tissues of human origin that will be used for implantation or administration.
• In vitro diagnostic medical devices (IVD): are those that are used to process samples of human origin in vitro to provide only information on a process, physiological or pathological deficiency status. Thus, a centrifuge marked as IVD medical device will be used for in vitro studies of samples from the human body with the purpose of providing information.

As a common element to determine what type of marking the centrifuges should have, we have the application to which the equipment is going to be used. Therefore, the user must be the one who determines said application, in order to know what type of certification he will need.

Ortoalresa offers a wide range of centrifuges for all types of applications, with the necessary certifications to meet the requirements of each laboratory.