Biocompatibility is a critical component of medical device safety and regulatory approval. Support is provided to medical device manufacturers through biocompatibility testing and biological safety assessment in line with ISO 10993, the international standard for evaluating materials and finished devices intended for contact with the human body.
The ISO 10993 series applies to a broad range of devices, from implants and invasive products to externally applied components that come into contact tissue or bodily fluids. A risk-based approach is central to the standard, integrating chemical characterisation, toxicological evaluation and biological testing to identify potential hazards and demonstrate patient safety.
Migrating species from medical device materials, particularly polymer-based components are a key consideration in biological safety assessment. Specialised extractables and leachables (E&L) studies (including anionic and cationic leachables) are designed to identify and quantify compounds that may migrate from a device under clinical use conditions.
A risk-based, device-specific approach is applied to ensure studies are appropriately scoped to the materials, processing methods and patient exposure. This results in robust, relevant data to support toxicological risk assessment and regulatory review in accordance with ISO 10993.
A wide range of advanced analytical techniques is used, including:
Expert toxicological assessment is provided for compounds identified during chemical characterisation studies. This includes evaluation of compounds of concern, derivation of safety thresholds and assessment of patient risk, contributing to a scientifically defensible biological evaluation strategy.
Comprehensive chemical characterisation and compound identification are supported through multidisciplinary laboratory capabilities. Techniques include mass spectrometry and NMR, complemented by FTIR, Raman and UV spectroscopy to ensure full characterisation of organic and inorganic species relevant to biocompatibility testing for medical devices.
In vitro cytotoxicity testing is performed in accordance with ISO 10993-5 (equivalent to USP <87>) to assess the potential cytotoxic effects of medical device materials or extracts.
Testing for ethylene oxide (EtO) sterilisation residuals is available to support compliance with ISO 10993-7 and demonstrate patient safety following EtO sterilisation.
Identification and characterisation of actual and potential degradation products arising from medical device materials during manufacture, sterilisation or use are supported by multidisciplinary scientific teams. This enables a complete biological safety evaluation across the device lifecycle.
Physico-chemical, morphological and surface characterisation services are available to support understanding of material performance, degradation behaviour and potential biological interactions.
| ISO 10993 Part | Scope | RSSL Capability |
| Part 5 | In vitro cytotoxicity |
Testing of materials and device extracts to assess potential cell toxicity |
| Part 7 | Ethylene oxide sterilisation residuals |
Analysis of residual EtO following sterilisation to ensure patient safety |
| Part 9 | Degradation products |
Identification and characterisation of actual & potential material degradation products |
| Part 12 | Sample preparation & reference materials |
Guidance and support for extractables and leachables studies |
| Part 17 | Toxicological risk assessment |
Evaluation of compounds of concern, derivation of safety thresholds, support for biological evaluation reports |
| Part 18 | Chemical characterisation |
Detection, identification and quantification of migrating compounds from materials |
RSSL deliver scientific, toxicological and biological testing expertise through laboratories equipped with state-of-the-art analytical instrumentation. Through a collaborative, risk-based approach, we ensure biocompatibility programmes are scientifically robust and aligned with regulatory expectations.
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