Climatic Chamber Configurator
Discover the Climatic Chamber Configurator
Our guide to choosing the climate chamber best suited to your needs.
Environmental testing for medical devices is a fundamental procedure to ensure 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 requirement is particularly crucial for obvious reasons.
In today's article, we'll explain in detail environmental testing for medical devices: which devices we're talking about, what the test is for, how it's performed, and what regulations it must comply with.
What We Mean by Medical Devices
A medical device is an instrument, apparatus, or software intended for diagnostic, therapeutic, or 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 Environmental Testing for Medical Devices Used For?
Environmental testing of medical devices aims 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 materials or alter performance. Environmental testing helps identify and mitigate these risks, ensuring that the device maintains its integrity and functionality throughout its life cycle.
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How Environmental Testing for Medical Devices Works
Environmental testing of medical devices involves simulating a series of environmental conditions in a controlled and reproducible context.
The fundamental parameters to monitor are temperature - with significant values at both extremes - andrelative humidity.
The most common values include temperatures ranging from -20°C to +70°C and relative humidity levels from 10% to 95%. Tests can be static, maintaining constant conditions for a prolonged period, or dynamic, simulating variation cycles to replicate real-world conditions.
The controlled environment required 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.
International Standard for Environmental Testing of Medical Devices
Environmental testing of medical devices must comply with specific international standards that define test requirements and methodologies. Here are some of the main ones:
- ISO 11607-1: Establishes 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 essential safety and performance standards for medical electrical equipment, ensuring that it is safe and effective for its intended use.
- ASTM D4332: Provides standard practices for conditioning containers and packaging components, simulating environmental conditions likely to be encountered during distribution and use.
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IEC 60601-1: Climatic requirements for medical electrical equipment
IEC 60601-1 is the fundamental standard for the safety of medical electrical equipment. Regarding environmental testing, the standard defines the reference climatic conditions in which the device must function correctly:
| Condition | Standard range | Notes |
|---|---|---|
| Operating temperature | +5C to +40C | The device must operate in this range |
| Operating humidity | 15% to 93% RH | Non-condensing |
| Transport/storage temperature | -40C to +70C | The device must survive without damage |
| Atmospheric pressure | 500 hPa to 1060 hPa | Equivalent to 0-4500m altitude |
The manufacturer must demonstrate, through climatic chamber tests, that the device:
- It works correctly at the limits of the operating range (+5C and +40C)
- It does not suffer damage after storage at extreme limits (-40C and +70C)
- Maintains electrical safety (insulation, leakage currents) in high humidity conditions
The FDM environmental chambers with a range of -70C / +180C cover all the requirements of IEC 60601-1 with a wide margin, both for operational tests and for transport and storage tests.
ISO 10993: Accelerated aging of biocompatible materials
An often overlooked aspect of environmental testing for medical devices is verification of biocompatibility over time . The ISO 10993 series (biological evaluation of medical devices) includes requirements for accelerated aging of materials in contact with the human body.
Accelerated aging is performed by exposing materials to elevated temperatures (typically 55°C-70°C) for controlled periods, following the Arh Enius rulerhevery 10°C increase approximately doubles the aging rate. Thus, a few weeks in a climate chamber equate to months or years of real-world use.
FDM laboratory furnaces and C -PRO climate chambers are ideal for these tests, with long-term temperature stability and continuous data logging compliant with GMP requirements.
The FDM Environmental Chamber for Environmental Testing of Medical Devices
For over 70 years, FDM – Environmental Makers has been a leader in environmental simulation.
Our environmental chambers are a technologically advanced solution for performing environmental testing of medical devices, in accordance with the requirements of international standards.
Furthermore, our technicians are always available to listen to each customer's specific needs and design a customized environmental chamber that meets their needs.
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Authoritative Sources for Medical Device Testing
- ISO 13485 — Quality management systems for medical devices.
- ISO 14971 — Application of risk management to medical devices.
- IEC 60601-1 — Medical electrical equipment: general requirements for safety.
- ISO 10993 series — Biological evaluation of medical devices (aging and biocompatibility).
- EU MDR (EU Regulation 2017/745) — European Medical Device Regulation.
- FDA — Medical Devices — FDA Guidance for 510(k), PMA, De Novo.
Frequently Asked Questions about Environmental Testing for Medical Devices
Which environmental tests are mandatory for CE marking in the MDR?
EU Regulation 2017/745 (MDR) does not list specific tests but refers to harmonized standards. For active medical electrical devices, IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and climatic tests according to Clause 15 (storage, transport, operating conditions) are required. For devices with a controlled shelf life (IVDs, consumables), ASTM F1980 (accelerated aging) and ISO 11607 (sterile barrier packaging) are required.
Difference between IEC 60601 and ISO 13485?
ISO 13485 is the quality system standard : it defines how a company should organize itself to produce compliant medical devices. IEC 60601 is the product standard : it defines safety and performance requirements for medical electrical equipment. They are complementary: ISO 13485 is a prerequisite for CE certification of the production process, IEC 60601 for the technical compliance of individual devices.
What environmental conditions are suitable for device storage testing?
IEC 60601-1 Clause 15.4 prescribes storage conditions ranging from -25°C to +70°C with 10-93% RH (non-condensing), plus 72 hours at extreme conditions prior to functional testing. For devices transported in cold chains (COVID-19 rapid tests, biological drugs), specific tests at -40°C are added with temperature excursion cycles that simulate international shipments.
How is accelerated aging of MD performed according to ASTM F1980?
ASTM F1980 applies the Arrhenius equation with Q10 = 2 (assuming that every 10°C increase in degradation rate doubles). Typical: 55°C for 57 days simulates 1 year at 25°C. The test is mandatory for sterile barriers (learn more) and to validate the shelf life declared on the label. ASTM F1980 chambers must maintain 55°C ± 2°C with humidity control for the entire duration of the test.
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