This plan acts as a risk assessment which evaluates the potential risks of the product, and whether they can be justified with existing data, or requires further biocompatibility testing. The BEP is an essential step in all classes of medical devices, as it is crucial for manufacturers to have complete technical files in order to ensure the safety, efficacy and performance of a product. This is re-instated is the ISO 10993 standard which states 'the biological evaluation of any material or medical device intended for use in humans shall for part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971'.
ISO 10993-3 Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. Genotoxicity AMES.
ISO 10993-4 Selection of tests for interactions with blood
ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. Hemocompatibility platelet activation. Hemocompatibility complement activation. Hemocompatibility haematology.
ISO 10993-5 Test for cytotoxicity – in vitro methods
‘in vitro’ tests are free from animal cruelty, hence a more rapid and sensitive procedure. Qualitative cytotoxicity tests outcomes in an assigned cytotoxic score (0-4) which is dependent on the percentage of cell death (lysis), and overall cell structure (morphology). Whereas quantitative tests measure the metabolic activity of the cells, consequently allowing the measurement of living (viable) cells. Devices are considered cytotoxic if less than 70% cell viability occurs post-treatment with medical device extracts.
ISO 10993-7 Ethylene oxide sterilization residuals
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. EO/ECH residual. EO/ECH exhaustive extraction.
ISO 10993-10 Tests for skin sensitization
ISO 10993-10 Skin sensitization testing assesses the possible contact of hazards from chemicals which are released from a medical device (MD) that could induce a hypersensitivity reaction e.g. an allergic reaction. Sensitization GPMT. Sensitization Buehler.
ISO 10993-11 Tests for systemic toxicity
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. Material mediated pyrogenicity. Acute systemic toxicity. Subacute toxicity. Subchornic toxicity. Chronic toxicity.
ISO 10993-17 Toxicological risk assessment of medical device constituents
ISO 10993-17 specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
ISO 10993-18 Chemical characterization of medical device materials within a risk management process
ISO 10993-18 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization. Headspace GC-MS. GC-MS. LC-MS. LC-MS HRAM. ICP-MS FT-IR direct. FR-IR extraction. Exhaustive extraction pre-test. UV-VIS.
ISO 10993-23 Tests for irritation – in vitro methods
The irritation testing in accordance with ISO 10993-23 allows for detection of irritants in medical devices. With the introduction of the In Vitro Recombinant human Epidermis (RhE) model for skin irritation, manufacturers can now look to determine irritation potential of their devices without the need for animal testing. The testing allows for detection of irritants from polar and non-polar extracts of devices as well as through direct contact with compatible creams, liquids and gels. The test method determines the viability of the RhE cells, with <50% viability as an indication of irritant potential.
Biological Evaluation Report
Upon the knowledge compiled in the BEP, a biological evaluation report (BER) can be issued. Within this report, all the justifications and testing performed will be stated. If the BEP indicates that all the materials have good evidence of safety, the processing of the material has no possibility of changing the safety, and there is overall no risk of contamination and the combination of the new material to the product is not toxic, then the BER will finally conclude that there is no further testing that is required.
Our biocompatibility testing is a fundamental step in allowing a medical device to be recognised as safe for use. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation. We offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 10993-5 to determine cytotoxic potential.
To determine which test are relevant to your device, we offer a biological evaluation plan (BEP) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.
Medical Device Biocompatibility Testing: Everything You Need to Know
Biocompatibility testing is fundamental in deciphering if a medical device is safe to use when introducing a medical device into t...
