While the performance thresholds remained largely the same, the prime objective of the 3rd edition standard was avoiding unacceptable risk in the event of failure, degraded performance, or functionality. Therefore, it required equipment developers to establish a Risk Management Process described in ISO 14971, determine acceptable levels of risk, and show that the remaining risk is acceptable. It also demanded greater interaction between the equipment manufacturer and the test laboratory, as illustrated above. This distinguishes between the criteria established by the risk analysis and the test processes used to demonstrate compliance.