The pandemic situation has made us all painfully aware of how vital medical electrical devices, such as intensive care ventilators, are to our survival.
While society as a whole has only recently become aware, for years the sector has been subject to very precise and very strict regulations to guarantee the safety of these devices.
Many of the tests for medical electrical devices need the support of a climatic chamber. Let's discover them together.
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The ISO 8601 Standards for Electromedical Equipment
The ISO is the International Organization for Standardization and, together with the IEC, the International Electrotechnical Commission, is the international body that is responsible for regulating the "Particular requirements for basic safety and essential performance of medical electrical equipment".
In particular, medical electrical equipment is regulated by ISO 8601, which incorporates the much older IEC 60601, developed for the first time in the 1970s and updated several times over the decades.
The two standards are largely overlapping, so much so that they are often referred to as ISO / IEC.
The ISO / IEC for medical electrical equipment has acquired a particular reputation among professionals as a “scary” standard due to the number of requirements and the accuracy of the norms. Let's see why.
Which equipments are regulated by ISO 8601?
The complexity of ISO 8601 for Electromedical Equipment derives in part from the quantity and variety of instruments that fall under this definition.
ISO 8601 is in fact an umbrella norm that is divided into over eighty specific sub-norm concerning a type of electro-medical device or a type of test.
The size and complexity of the devices vary a lot along with the types of tests required. For example, there are the aforementioned ventilators for intensive care, but also electronic thermometers, cardiac defibrillators and the wide family of X-ray diagnostic devices.
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The Climatic Chamber Test for Medical Electrical Equipment
As you can guess, the breadth and variety of medical electrical devices entail an equal breadth and variety of climatic chamber tests which cannot, therefore, be summarized. We recommend downloading the specific standard for the device in question.
However, there are some generalizable aspects.
The climatic chamber test for medical electrical devices aims to verify the stability of the equipment at certain temperatures and certain humidity levels.
For example, all medical electrical equipment with no separate power supply must be placed in a climatic chamber (relative humidity 93% ± 3%) and environment within 2 ° C of temperature in the range between + 20 ° C and + 32 ° C for 48 hours.
The FDM Climatic Chamber for Testing on Medical Electrical Equipment
FDM - Environment Makers has been working with the same passion since 1949 and our standard climatic chamber is equipped to carry out all the temperature and humidity tests necessary for the approval of medical electrical devices according to ISO 80601.
Furthermore, our team can work on customized climatic chambers in order to satisfy all needs. Please contact us.
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