1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the repair and/or replacement of heart valves. This guide is intended for use related to the in vitro assessment of TEMP heart valves.

1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.