A medical device must be intended to be used for human beings for a medicinal purpose, which does not achieve its principal intended action by pharmacological, immunological or metabolic means according to national legislation, e. g. MPG (Medical Device Law in Germany). It needs to be proven that no adverse effects (on cellular basis, local tissue reaction or systemic effects) will be caused by the device after getting into contact with a patient, user or any other person.
An essential step in the progress of certification of a medical device is the thorough evaluation of biological safety (biocompatibility) as described in ISO 10993 guidelines.
Based on BSLs active membership in different national and international committees the company guarantees that its service is carefully coordinated with the requirements necessary for registration procedures. BSL BIOSERVICE assists you in choosing the appropriate test and develops the optimal test strategy for the products.
Biological evaluation to ISO 10993 standards
ISO 10993 describes the general principles governing the biological evaluation of medical devices within a risk management process.
The evaluation may include both a study of relevant preclinical and clinical experience and the actual testing that allows a full risk assessment. Chemical characterization of materials is a crucial first step in the biological evaluation.
Based on the available information and the material characterisation, biological testing shall be considered as part of the overall risk management process. Depending on the category of the medical device, according to the nature and duration of body contact, several biological endpoints might have to be evaluated as described in ISO 10993-1.
The ISO 10993 guideline is generally accepted worldwide. For some, endpoints and studies differences in the study design are required for international authorities, e.g. MHLW Japan and US FDA.
Whether your need is the biocompatibility testing according to ISO 10993 or microbiological testing within development, production and finished product testing, BSL BIOSERVICE will support you with individual testing strategies and study designs to fulfill your needs. In addition, BSL BIOSERVICE offers further testing strategies for medical devices as well as for raw materials and semi-finished products.
Biocompatibility test panel
The company’s biocompatibility test panel functions include:
- Cytotoxicity
- Sensitisation
- Irritation
- Systemic toxicity
- Subchronic toxicity
- Genotoxicity
- Pyrogenicity
- Implantation
- Haemocompatibility
- Chronic toxicity
Microbiology test panel
BSL BIOSERVICE’s microbiology test panel comprises:
- Test for sterility
- Endotoxins
- Bioburden
- Test for specified microorganisms / microbial limit test
- Test for antimicrobial preservation
- Validation of test methods
- Identification of microorganisms
- Test for antimicrobial efficacy
- Evaluation of reusables for the intended reprocessing procedure (cleaning, disinfection, sterilisation)
- Environmental monitoring
- Process water testing
- Analysis of bioindicators
- Sterilisation processes
- Validation of depyrogenation processes
Additional services include:
- Functional implantation studies (ISO 10993-6)
- Identification and quantification of degradation products (ISO 10993-15)
- Packaging validation (ISO 11607)
- EO residue determination (ISO 10993-7)
- Ophtalmic implants – intraocular lenses (ISO 11979-5)
- Various test designs according to ISO Standards, USP and PH. Eur.
Reviewing biocompatibility data
A review and evaluation of the literature and already existing biocompatibility data is essential for the justification and planning of any biological evaluation of a material or a medical device.
The aim of this review is to determine scientific background for the biological evaluation. It also provides essential information for assessing risks and benefits as well as achieving the ethical conduct of the planned evaluation as required by the animal welfare according to ISO 10993-2.
Based on already existing literature or biocompatibility data the re-evaluation of a material or medical device shall be performed with a so called ‘bridging study’.
A review can be helpful to assess whether the relevant data available in the literature and already existing biocompatibility results are sufficient to demonstrate biological safety of the device in question. If the available data are sufficient, no further data needs to be generated from actual testing.
A bridging study might also be suitable for evaluation of a product consisting of materials sufficiently described being biocompatible in international valid guidelines (i.e. ISO 5832, ISO 7153).
Contact BSL BIOSERVICE
Please contact BSL’s medical device experts to find out more using the form or email addresses below. They would be very happy to discuss your project in detail.