This document specifies methods to evaluate the performance of a specific class of analytical instruments, known as compliance monitoring devices (CMDs). These instruments are designed and intended to examine ballast water to determine whether a sample meets or exceeds limits for the concentration of living or viable organisms. These limits include those specified by the International Maritime Organization (IMO) Regulation D-2 in the International Convention for the Control and Management of Ships' Ballast Water and Sediments or other discharge standards (DS) adopted by national or regional authorities.
The test methods measure the agreement between the CMD and a reference method to calculate trueness and precision. Both trueness and precision consider only simple, categorical outcomes (e.g. “meets” or “exceeds” the DS). The performance metric reliability is quantified by the frequency of instances when the CMD is not available or is not operating as expected.
The set of tests and trials is based upon the CMD manufacturer claims, such as the DS group(s) targeted by the CMD, and known limitations, including those based upon the salinity of the sample water.
NOTE Additional tests and trials, if required by the end-user, can follow this general test method. Guidance on determining experimental power is found in 7.5. This document provides guidance for customizing the tests to evaluate the claims of the manufacturer or to address optional factors of interest to the end-users.
This document does not set or recommend success criteria of any performance metric, as these are appropriately defined by the end-users.