Medical devices environmental testing is a fundamental procedure to guarantee their safety and reliability in accordance with international regulations.
All the products and materials we use in our lives must be safe and reliable, but for medical devices this need is particularly crucial for obvious reasons.
In today's article we will explain in detail medical devices environmental testing: which devices we are talking about, what the test is for, how it is performed and which regulations it must comply with.
What We Mean by Medical Devices
A medical device is an instrument, appliance or software intended to be used for diagnostic, therapeutic or human health monitoring purposes. Unlike products such as cosmetics or wellness items, medical devices have a direct impact on the diagnosis or treatment of clinical conditions.
For example, a digital thermometer used to measure body temperature is considered a medical device, while a fitness bracelet that monitors physical activity is not.
The distinction is crucial, as medical devices must meet rigorous safety and performance standards to ensure patient protection.
What is Medical Devices Environmental Testing Used For
Environmental testing of medical devices is designed to evaluate how medical devices react to extreme or variable climatic conditions, such as high or low temperatures and high humidity levels.
These tests are essential to prevent malfunctions that could compromise patient safety.
For example, during transport, a device may be exposed to high temperatures that could damage the materials or alter performance. Environmental testing helps identify and mitigate these risks, ensuring that the device maintains its integrity and functionality at different stages of its life cycle.
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How Medical Devices Environmental Testing Works
Medical devices environmental testing involves simulating a series of environmental conditions in a controlled and reproducible context.
The key parameters to monitor are temperature - with significant values
The most common values
The controlled context needed to perform environmental testing on medical devices is the environmental chamber.
The environmental chamber is a laboratory instrument consisting of a hermetically sealed compartment within which it is possible to set, alter and monitor environmental parameters, such as temperature and relative humidity.
The various procedures for performing environmental testing on medical devices are outlined in a series of internationally recognized standards.
Medical Devices Testing Standards
Medical devices environmental testing must comply with specific international standards that define the requirements and test methodologies. Here are some of the main ones:
- ISO 11607-1: Establishes the requirements for sterile barrier materials and systems used in the packaging of terminally sterilized medical devices, ensuring that they maintain sterility up to the point of use.
- IEC 60601-1: Defines the essential safety and performance standards for electrical medical equipment, ensuring that they are safe and effective for their intended use.
- ASTM D4332: Provides standard practices for the conditioning of containers and packaging components, simulating the environmental conditions that may be encountered during distribution and use.
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The FDM Environmental Chamber for Medical Devices Environmental Testing
For over 70 years, FDM - Environmental Makers has been a leading company in environmental simulation.
Our environmental chambers are a technologically advanced solution for carrying out environmental testing of medical devices, in accordance with the requirements of international standards.
Furthermore, our technicians are always available to listen to the specific needs of each customer and design with them a customized environmental chamber that meets their needs.
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