Biotechnological safety
Testing of isolators and safety cabinets in accordance with the Product Safety Act
Testing of isolators and safety cabinets in accordance with the Product Safety Act
Safety cabinets and isolators play a crucial role in the handling of dangerous microorganisms and highly effective toxic substances such as cytostatics. TÜV NORD CERT offers manufacturers and users support through product testing in accordance with the requirements of the Product Safety Act. Our experts, whose decades of experience have significantly shaped the relevant product standards, help you to establish and maintain a high level of safety.
The GS mark stands for quality and safety in Europe and many other countries around the world. It indicates that the product, including its instructions for use, has been tested by an independent institution. Products with the GS mark are favoured due to their proven safety and offer a clear competitive advantage.
With its new edition, published at the end of 2025, the European standard EN 12469 has undergone a fundamental revision. Since May 2000, it has defined the requirements and test procedures for biological safety cabinets (BSCs). The revision incorporates experience gained since the introduction of the standard, updates the test methods to reflect the state of the art, and places greater emphasis on evaluating the actual performance of the cabinets.
Another major change is the division of the standard into several parts, providing greater flexibility for future updates and creating a clearer structure:
The new EN 12469 specifies numerous test and evaluation methods in greater detail. It includes updated measurement procedures and acceptance criteria. Additions include specifications for lighting measurement grids, setups for sound and alarm tests, and for airflow visualization.
The standard also introduces a closer link to ISO 14644‑3 for conducting filter tests and provides a detailed description of which tests apply during type testing, installation tests, and routine tests.
Additional marking requirements increase transparency by clearly stating the tested operating parameters.
Earlier versions of the standard provided indicative values for air velocities, for example for the downflow (0.25 to 0.50 m/s). However, these figures were intended solely as design guidance for manufacturers and did not represent general safety requirements.
A common misconception was that maintaining a mean downflow velocity between 0.25 and 0.50 m/s automatically ensured compliance with the standard and safe operation of a safety cabinet. In reality, safety depends not solely on air velocity but on the careful balance between the inflow and downflow air streams established by the manufacturer.
The earlier EN 12469:2000 already required adherence to the manufacturer’s specified settings and their verification during performance testing. The current edition continues this approach and deliberately avoids prescribing fixed airflow values. The focus is now on verifying the protective performance — based on the manufacturer’s specified operating parameters and independent of predefined velocity targets.
To assess this protective performance, provocation point testing (stability of protective functions) have been introduced. These tests check whether the defined operating parameters are sufficiently robust to maintain protective performance even when minor deviations or external influences occur.
In the future, all safety‑relevant parameters verified during type testing must be clearly listed on the cabinet’s nameplate. This enables operators and test laboratories to easily identify which settings are essential for safe operation.
Part 5 introduces, for the first time, a section addressing organizational and technical aspects of cabinet operation. It defines requirements and recommendations for installation, commissioning, routine testing, and safe operation of biological safety cabinets.
The section also provides guidance on laboratory placement to prevent disruptive air movements and specifies requirements for the structure and scope of measurement and test records. This new part is intended particularly to raise awareness among users and operators: only a properly installed and maintained unit can ensure lasting protection.
TÜV NORD is actively involved in European standardization efforts and contributes its testing expertise to the ongoing development of EN 12469. The goal is to formulate practical and reliable requirements that provide manufacturers and operators with clear guidance for the safe use of biological safety cabinets.
"Specialist Qualification for Service Technicians for Microbiological Safety cabinets and safety cabinets for handling cytotoxic substances."
This seminar is suitable for surveillance personnel, safety officers, service technicians, supervisory authorities, and technical managers. It offers service technicians the opportunity to deepen their expertise in handling microbiological safety cabinets and safety cabinets for handling cytotoxic substances. Please register using the seminar flyer for the next seminar from January 19 - 23, 2026 in Hamburg, Germany or contact us for further dates and details.
The Biotechnological Safety Department of TÜV NORD CERT offers the following services as a test center:
For further information on our services and seminars, please do not hesitate to contact us.