ISO TR 21582 Pyrogenicity - Principles and Methods for Pyrogen Testing of Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO TR 21582 testing. This standard specifies principles and methods for pyrogen testing of medical devices and their materials.

Currently, safety assessments of medical devices are guided by toxicological and other studies recommended in the ISO 10993 series of standards.

Material-mediated pyrogenicity represents a systemic effect included in ISO 10993-11:2017, Annex G, but efforts have been made in this document to address pyrogenicity testing in general.

A pyrogenic response is the adverse effect of a chemical or another substance, such as a microbial component, to produce an inflammatory response. Pyrogenic response tests were required to evaluate the safety of products that have direct or indirect contact with the blood circulation and lymphatic system, cerebrospinal fluid (CSF), and interact systemically with the human body.

Currently, in vivo rabbit pyrogenicity testing and in vitro bacterial endotoxin testing are available as accepted methods for assessing the pyrogenicity of medical devices and their materials. Basic procedures, including sample preparation from each test article, have already been established, internationally harmonized and specified in relevant guidelines and pharmacopoeias.

Recently, an in vitro pyrogen test using human immune cells, the human cell-based pyrogen test (HCPT), has been developed and applied for pyrogen testing of parenteral drugs. The concept of applying pyrogen testing for medical devices is being evaluated due to direct or indirect exposure to human blood cells (HCPT).

An instrument, apparatus, instrument, machine, instrument, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer for use, alone or in combination, for one or more people.

It includes:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnose, monitor, treat, mitigate or compensate for an injury;
• Research, modification, modification or support of anatomy or a physiological process;
• To support or sustain life;
• control of conception;
• disinfection of medical devices;
• Providing information through in vitro examination of samples obtained from the human body and does not exert its primary intended effect in or on the human body by pharmacological, immunological or metabolic means, but may aid its function by such means.

Products that are considered medical devices in some jurisdictions but not in others include:

• disinfectants;
• benefits for the disabled;
• Devices containing animal or human tissues;
• Devices for IVF or assisted reproductive technologies .

EUROLAB assists manufacturers with ISO TR 21582 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.