Medical Services

Biocompatibility Testing for Global Regulatory Submissions

UL offers the medical device industry 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 medical device markets in the world - ISO 10993, USP, or MHLW. By working with UL for your biocompatibility testing, you also have the benefit of consolidating your test plan, which can save time by not having to manage multiple test labs.

What is Biocompatibility Testing?

Biocompatibility is defined as "the capability of coexistence with living tissues or organisms without causing harm."¹ For medical devices, which come into contact with the human body for the purpose of treatment, diagnosis, or physical aid, making sure 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.

Testing for one or more countries at once

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. U.S.P. (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 that is different from both the ISO 10993 and U.S.P. protocols. Through UL's network, we offer our customers a complete test package to satisfy requirements for all three countries and test requirements, and use the "worst case" criteria to minimize testing, samples required, and time.

Advantages to UL's Biocompatibility Testing Services

• 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 UL's network 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 & distribution needs.

Additional Resources

• (1) Download Matrix of Biocompatibility Requirements for ISO , FDA, and MHLW (Registration required)

¹ Dictionary.com Unabridged (v 1.1), Based on the Random House Unabridged Dictionary, © Random House, Inc. 2006. Accessed 10Dec07.