Biocompatibility testing for medical devices according to DIN EN ISO 10993
Biocompatibility testing for medical devices according to DIN EN ISO 10993
ISO/IEC 17025,
GLP, GMP
Independent
test lab
Chem. & phys.
characterisation
Biol. & mikrobiol. testing
Biocompatibility testing according to ISO 10993 for medical devices
Healthy with safety: test methods according to international standards
Medical devices are an essential part of healthcare for people around the world. As such, they are subject to strict regulatory requirements for safety and quality.
In our ISO/IEC 17025 accredited and GLP certified laboratories, BIOSERV carries out numerous analyses to verify the biological safety of products or starting materials, as well as the validation of packaging and manufacturing processes. We also support manufacturers of medical devices in all phases of the product cycle – from development and approval to production.
| Research & Development | Preclinical phase | Clinical phase | Market readiness | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| chemical characterization | in vitro | in vivo | I | II | III | IV | Authorisation | Production | Distribution | ||
| Our competencies | ✔ | ✔ | ✔ | ✔ | ✖ | ✖ | ✖ | ✖ | ✔ | ✔ | ✖ |
| Our competencies | |
|---|---|
| Research & Development | ✔ |
| Preclinical phase chemical characterization in vitro in vivo |
✔ ✔ ✔ ✔ |
| Clinical phase I – IV |
✖ ✖ |
| Market readiness Authorisation Production Distribution |
✔/✖ ✔ ✔ ✖ |
Class A to D cleanrooms are available for special requirements.
Our experienced scientists test each product individually and in accordance with current regulatory standards and guidelines. The focus is always on efficient and economical strategies.
Biocompatibility testing in accordance with DIN EN ISO 10993
Biocompatibility testing in accordance with DIN EN ISO 10993
Devices should be designed, manufactured and packaged in such a way as to minimise the risks posed by harmful substances and residues to patients, taking into account the intended purpose of the device, and to transport, storage and operating personnel (MDD, Annex I, paragraph 10.2).
Providing this evidence for new or modified devices is very challenging, not least because of the diversity of the product landscape and the complex regulatory requirements. The DIN EN ISO 10993-1 standard provides good guidance on the basic approach and selection of tests required.
Chemical characterisation using GC-MS or ICP-OES can determine whether organic or inorganic substances can be released from the product, the packaging or impurities from the manufacturing process that pose a risk to the patient. BIOSERV tests according to different standards for different material categories (polymers, ceramics or metals). Repeated tests after ageing or reprocessing are also part of our portfolio.
As part of the toxicological risk assessment according to DIN EN ISO 10993-17, comprehensive statements on biological safety are already possible at this level.
Other biological tests range from simple cell culture models such as the cytotoxicity test to complex in vitro models for testing irritation, haemocompatibility or genotoxicity, acute or chronic systemic studies and implantation studies. Thanks to our own histopathological laboratory and the broad expertise of our scientists, BIOSERV offers these services from a single source.
In addition to the testing of medical devices under accredited or GLP conditions, we also offer many of these services for preclinical GLP-compliant testing of drugs and active ingredients.
3R Prinzip – Reduce, Refine, Replace
Animal welfare is at the heart of our business. We are constantly working to establish alternative test methods and improve existing in vivo methods. In recent years, tests for skin and eye irritation have been successfully transformed and accepted as a standard (10993-23).
Nevertheless, patient safety remains central. This can only be guaranteed by safe products. For invasive high-risk products and implants, a holistic testing approach is essential, which BIOSERV offers as a full-service provider.
Range of biocompatibility testing services
Manufacturing Control
In addition to the risks posed by the product itself, flawless production, packaging and cleaning processes are necessary to ensure product safety. The focus is not only on the microbiological quality of the products, but also on the quality of the critical environments (air/surfaces/water).
We monitor product and environmental hygiene during the manufacturing process. After processing, we check the microbiological quality or sterility of your products and the suitability of the packaging. The subsequent identification of existing microorganisms allows better root cause analysis of the origin of existing contamination and improves the derivation of prevention and elimination measures.
Physical test methods for checking the production and cleaning processes, such as particle tests, leakage tests of seals, determination of the residual protein content after reprocessing or effectiveness tests of the liquid filter, must be considered on a product-specific and application-related basis.
We are happy to assist you in the qualification of your processes.
Range of microbiological testing services
GMP Laboratory
Regulatory or quality assurance testing is mandatory for safe and high quality pharmaceuticals and is increasingly being monitored and regulated by the authorities.
BIOSERV carries out tests on medicinal products, active substances and excipients as well as raw materials and packaging materials within the scope of its accreditation according to 17025 and certification as a GMP testing facility.
In addition to microbiological quality control, we offer chemical characterisation for proficiency testing or stability control and preclinical test models in vitro and in vivo.
Range of GMP services
