Biocompatibility and Toxicology Test

Applicable Standards

• ISO 10993
• ISO 18562
• USP 66.1
• USP 66.2
• USP 1661
• USP 1663
• 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

Manufacturers of today's complex devices must evaluate the biocompatibility of drug containers and combination device materials and processes by taking 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 house a medicine container or combination device at any stage of the product life cycle.

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 medication container or combination 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 need to complete the biological assessment;
• general biological safety consequences for the medical device. 

Service Summary

EUROLABISO 10993 for Extractables and Sealants offers a complete trifecta to meet the requirements for Biocompatibility and Toxicological Assessments of pharmaceutical containers and combination devices. Biocompatibility testing is very common in the pharmaceutical container and combination 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 medication container or combination 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.

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