Biocompatibility and Toxicology Tests

Instead, manufacturers of today's complex devices must evaluate the biocompatibility of medical device materials and processes using a holistic risk-based approach to biological safety assessments.

Our experts divided the biological safety assessment process into three distinct stages that can be used to deploy a medical device at any stage of the product life cycle.

Applicable Standards

• ISO 10993
• ISO 18562
• US FDA ISO 10993-1 Guidance Document (September 2016)
• MDR Regulation (EU) 05/2017 of the European Parliament and the Medical Devices Council of 2017 April 745

Biological Assessment Plan (BEP)

Biological Evaluation Plan (BEP), EUROLAB It is an initial risk assessment provided by and aims to meet the objectives of ISO 10993-1, clause 4 “General principles applied to the biological evaluation of medical devices”. The first part of this article specifically states that “Biological evaluation should be planned, implemented and documented by knowledgeable and experienced professionals.” The BEP takes into account the materials, processing, and historical use of the device. The output is a signed biological assessment plan that recommends the testing and information needed to demonstrate device safety.

Testing

Do the tests outlined in BEP. This test may include chemistry testing, biocompatibility testing, and / or written risk assessments.

Biological Assessment Report (BER)

Biological Assessment Report (BER), ISO 10993-1: 2018, clause 7: “Expert assessors with the necessary knowledge and experience should identify and document:

• The strategy and planned content for the biological evaluation of the medical device;
• Criteria for determining the acceptability of the material for the intended purpose in accordance with the risk management plan;
• Adequacy of material characterization;
• Justification for selection and / or waiver of tests;
• Interpretation of existing data and test results;
• Any additional data requirement to complete the biological assessment;
• General biological safety consequences for the medical device.

Service Summary

EUROLABoffers a complete set of three components to meet ISO 10993 requirements for extractables and seals, biocompatibility and toxicological risk assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with a unique set of testing requirements, the biocompatibility testing experience can be daunting. Even after a device is categorized, numerous decisions remain for each test.

Our Technical Advisory group can provide full service experience. If you know ISO 10993 and its requirements, you can also select the services you need below. Each medical device must undergo three common biocompatibility tests (commonly referred to as the Big Three): cytotoxicity, sensitization and irritation tests. Each test scans for the presence of toxic, leaking substances. Depending on the category of the device, up to five additional test categories may be required (see Test matrix).

If you have additional questions about Biocompatibility and Toxicology testing or EUROLABYou can consult the experts at .

Testing Services:

• cytotoxicity
• genotoxicity
• Hemokompatibilit to
• Implantation with Histopathology Tests
• Irritation
• ISO 18562: Biocompatibility Assessment of Respiratory Gas Road Devices
• Physiochemical USP Plastic Test
• Risk assessment
• Sensitivity
• Sub-Acute and Sub-Chronic Toxicity
• Systemic Toxicity Test (Including Pyrogenicity)

EUROLAB, with its highly expert team and internationally accredited laboratories, Biocompatibility and Toxicology Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.