Medical device testing is one of the most complex services offered in the life sciences sector, both for the diversity of the devices tested and for the different level of safety or biocompatibility required prior to approval for use in patients.
It is also one of the fastest growing industries in healthcare with a high demand for reliable testing services.
The classification of ‘medical device’ covers a wide range of device types, and each requires various levels of safety or biocompatibility testing prior to market release and again if any of the design components and materials are updated.
The required tests are generally referred to as the ISO 10993 or USP Plastic Class I-VI series, although there are a variety of other tests which may be required (such as the sterility and bioburden testing covered by the ISO 11135 and 11737 series).
In collaboration with our approved partners, we now offer a full suite of medical device testing, including the following tests:
• BS EN ISO 10993-1: Biological Safety Assessments
• BS EN ISO 10993-3: Genotoxicity
• BS EN ISO 10993-4: Haemocompatibility
• BS EN ISO 10993-5/USP 87: Cytotoxicity
• BS EN ISO 10993-6/USP 88: Implantation
• BS EN ISO 10993-10/USP 88: Sensitisation and Skin Irritation
• BS EN ISO 10993-11/USP 88: Acute, Sub-acute, Chronic Systemic Toxicity and Pyrogenicity
• BS EN ISO 10993-13/14/15: Identification and Quantification of Degradation from Polymers, Ceramics, Coated and Uncoated Metals and Alloys
• BS EN ISO 10993-18: Chemical Characterisation of Materials
• BS EN ISO 11135: Sterilization of health care products – Ethylene oxide
• BS EN ISO 11137: Sterilization of health care products – Radiation
• BS EN ISO 11138: Sterilization of health care products – Biological Indicators
• BS EN ISO 11737-1: Sterilization of medical devices – Microbiological methods (Bioburden Determination)
• BS EN ISO 11737-2: Sterilization of medical devices – Microbiological methods (Sterility)
• BS EN ISO 17655: Sterilization of healthcare products – Moist heat
At Wickham Micro, our qualified technical experts and partners are fully experienced in the standards governing medical device testing for development work in proof of concept projects, regulatory submission packages and routine post market authorisation analysis. We are familiar with a wide range of device types, along with the different methods used to test them, which is vital given these methods will vary depending on factors such as level of patient contact in terms of duration, and where in the body they are likely to be used or applied.
Most of our medical device testing is conducted under GLP study plans, which are particularly useful where the client is seeking regulatory approval of a product for instance via CE marking claims support with notified bodies, or a 510K submission in the United States. Our team will assess each device on an individual basis to offer the best advice for your specific requirements.
Medical Device Sterility Testing
Sterility testing is a vital regulatory requirement for both pharm...