作者: Almir Badnjevic , Lejla Gurbeta , Elvira Ruiz Jimenez , Ernesto Iadanza
DOI: 10.3233/THC-161269
关键词:
摘要: The medical device industry has grown rapidly and incessantly over the past century. sophistication complexity of designed instrumentation is nowadays rising and, with it, also increased need to develop some better, more effective efficient maintenance processes, as part safety performance requirements. This paper presents results tests conducted on 50 mechanical ventilators infant incubators used in various public healthcare institutions. Testing was accordance requirements stated relevant international standards, directives legal metrology policies. output parameters for performed 4 measuring points while testing 7 each incubator. As criteria, relative error absolute calculated. ranges permissible error, both groups devices, are regulated by Rules Metrological Technical Requirements published Official Gazette Bosnia Herzegovina No. 75/14, which defined based recommendations, standards guidelines. All were tested etalons calibrated an ISO 17025 accredited laboratory, provides compliance all measured parameters.The show that 30% devices not operating properly should be serviced, recalibrated and/or removed from daily application.