Biocompatibility testing for global regulatory submissions
UL offers the health sciences industries a way to complete another required submission through one provider. UL's biocompatibility test services meet the requirements of the specifications generally accepted by the three major global medical device markets: ISO 10993, USP, or MHLW. Working with UL for biocompatibility testing provides the benefit of test plan consolidation, which can be faster than managing multiple test labs.
Biocompatibility is defined as "compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection." For medical devices, which come into contact with the human body for the purpose of treatment, diagnosis, or physical aid, making sure that every point of contact will not cause irritation, changes in blood composition, or toxic response is especially critical. Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, shipping, packaging, and sterilization may have adverse affects on the material's composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals.
Simultaneous testing
The three global major medical device markets prescribe different test protocols to assess biocompatibility in medical devices. The U.S. FDA and European Union commonly accept the ISO 10993 standards for biocompatibility. USP (U.S. Pharmacopoeia) standards are accepted by the U.S. FDA, are generally regarded as more stringent, and may be used by manufacturers as a marketing tool or for specific uses. Finally, Japan's MHLW has test criteria different from both the ISO 10993 and USP protocols. Through UL's family member, mdt medical device testing, GmbH (MDT), we offer our customers a comprehensive test package to satisfy requirements for global regulatory approvals, and use the "worst case" criteria to minimize testing, samples required, and time.
The UL advantage
- Custom project planning -- Our staff will work with you to prepare a project plan to meet your current and future product launch needs. This includes meeting with senior-level scientists with years of experience in preparing test protocols to meet regulatory submission requirements.
- Experience -- Through MDT, a UL company you gain access to over 50 years of experience in analytical chemistry, biocompatibility, toxicology, bioanalytical, microbiological, pharmacology testing, and specialty services.
- Global accreditation services -- UL is a leader at getting our customers access to existing and emerging markets so you only need to work with one test, regulatory and certification provider to meet your global sales and distribution needs.
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