ISO 37137-1 Biological Evaluation of Absorbable Medical Devices - Part 1: General Requirements

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 37137-1 testing. This standard specifies requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including the explanation of the terms "absorption", "degradation" and other related terms.

Absorbable implants are designed to intentionally degrade and thus release degradation products to the patient; this is a feature that fundamentally differentiates these products from other medical devices that are not intended to be absorbed by the patient's body.

The purpose of the content provided is to explain potential approaches to performing bioassessment of absorbable implants to support the safety of such absorbable medical devices.

Biological evaluation is the evaluation of a medical device, medical device component or material, medical device material or medical device design, or both, to determine whether it will cause an unacceptable systemic or local impact on the environment. The biological assessment of an absorbable material should be made in accordance with ISO 10993-1 and other relevant parts of ISO 10993. Any changes to the methods specified in the ISO 10993 series of standards must be justified in a written biological risk assessment.

Identification of degradation products can be obtained from chemical and physical analyzes of the implant or from a theoretical judgment. Literature data for implants manufactured from absorbable materials with a history of safe clinical use (at the intended anatomical location) may be helpful in identifying expected degradation products and potential toxicities if there is sufficient scientific justification for the applicability of the referenced data.

In addition, standard extraction conditions and biocompatibility tests are not designed to assess biological responses to absorbable devices during degradation. As absorbable devices are constantly changing in the physiological environment and may exhibit different adverse biological responses at different stages of degradation, testing at different stages of device degradation may be required to demonstrate safety.

EUROLAB assists manufacturers with ISO 37137-1 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.