Specifications for equipment used for infant pulmonary function testing

The aim of this position paper is to define minimal performance criteria for the separate items comprising equipment used to measure respiratory function in infants together with overall performance criteria for the assembled pieces of such equipment. These guidelines cover numerous aspects including: 1) safety, 2) documentation and maintenance of equipment, 3) physical characteristics of mechanical parts and signal transducers, and 4) data acquisition. Further, validation procedures for individual components as well as for the integrated equipment are recommended. Adherence to these guidelines should ensure that infant lung function measurements can be performed with an acceptable degree of safety, precision and reproducibility. They will also facilitate multicentre collection of data and performance of clinical investigations. Manufacturers of infant respiratory function equipment should make every effort to comply with these guidelines, which represent the current standards of paediatric health professionals in this field.