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October 9, 2026
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Operating rooms are facilities in which biosecurity plays a fundamental role since they are spaces in which processes are carried out that directly affect the safety of people. In this way, the law has established the minimum security conditions that must be met in the operating rooms. We tell you everything you need to know about it.
The UNE 171340 regulation aims to establish the main foundations for the proper functioning of the controlled environment rooms of health centers, including, of course, biosecurity in the operating room.
the ‘Protocol for the monitoring of environmental biosecurity in rooms of controlled environment in health centers’, published by the Andalusian Preventive Society, establishes that “the UNE standard 171340:2020 gives us the methodology and test method to carry out the validation and qualification of controlled environment rooms in health centers, defines the parameters to be assessed and the Frequency, to ensure biosecurity.As a novelty, the risk of each of the controlled environment rooms is categorized according to the existing risk to the biosecurity of the patient”.
In the UNE 171340 regulations, the different phases of design and execution through which said room passes are established, differentiating between critical and peripheral zones, as well as the different states in which a controlled room can be found. The doctor GLORY CROSSING, Bachelor of Medicine and Surgery, as well as Senior Technician in Indoor Environmental Quality, breaks down the key differences of the UNE 171340.
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state of the rooms
According to UNE 171340, a controlled room can be in two conditions: in sleep mode and in operation:
This is undoubtedly very relevant since the action and cleaning protocols of the room will not be the same if it is at rest or operation, taking into account that the objective of UNE 171340 is to guarantee the biosecurity of the operating room.
Technicians who carry out validations through quality controls, as well as the companies for which they work, must have the following:
In relation to the companies in charge of carrying out the validations, a quality management system and the calibration of measuring equipment are required, including the calibration of the equipment, the traceability of the patterns and the training of the personnel who carry out the calibrations. The UNE 171340 regulations establish all these requirements as a way to ensure that quality control is the maximum possible to try to guarantee the biosecurity of the operating room or the controlled environment room that we are talking about.
The UNE 171340 standard classifies zones of controlled environment into five levels of risk, from 1, ‘light’, to 5 ‘very high’.
This classification is made taking into account the risk to which the patient is subjected during his surgery. In addition, variables such as the number of people around the patient, the movement of personnel, the location, dimension and exposure time of the incision made, the prevention of entry of less clean areas, the possibility that the adjacent areas pollute the main room and the patients with immunosuppression are taken into account, among others. This will subsequently impact the protocols established to try to guarantee biosecurity within the operating room.
What tests and tests are done to verify a controlled environment room and ensure the biosecurity of an operating room? According to JECMA, the consulting and environmental company, the procedures to be followed to guarantee the validation of the UNE 171340 standard, are as follows:
LABSOM It uses the UNE 171340 regulations to continue designing clean rooms tailored to the needs of each project, from conceptual engineering to detail. If you have any questions, do not hesitate to contact us.
Yes. Although at first, when the UNE standards are drafted, they are voluntary, they can be mandatory if the authority approves them as mandatory laws or regulations. In the case of the UNE 171340 standard, it has been established that it is mandatory to guarantee biosecurity in operating rooms and other controlled environment rooms.
No, obviously there are areas within a hospital where, despite having to comply with a certain level of safety and cleanliness, since it is after a sanitary installation, procedures or processes are not carried out that may pose a high or very high level of risk, such as corridors, wait, etc
Depends. Of course, in both cases, a series of requirements must be met so that a level of asepsis and correct safety is maintained, however, depending on the processes that are carried out within both facilities, the security protocols as well as the specifications established by the regulations will be different.
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