A Cnla Certified Testing Laboratory for Electrical Medical Apparatus

Abstract

The establishment of a certified ISO Guide 25 testing laboratory for medical devices is an important corner stone for a better national medical device management system and practices of the assorted standards or guidelines. It can also contribute significantly to the educational program for clinical engineer. As a starting point, a medical electrical safety-testing laboratory according to the AAMI ES-1 (1993) and IEC 60601 (1988) has been setup and devoted to the safety of electromedical apparatus with joined efforts of the Institute of Biomedical Engineering, National Taiwan University and Department of Biomedical Engineering, National Taiwan University Hospital. To ensure its quality of services, ISO/IEC Guide 25 is implemented and certified by Chinese National Laboratory Accreditation (CNLA). In view of the global harmonization, this painstaking procedure for a medical device-testing laboratory can be fruitful in the aspects of quality assurance for the imported devices and post-market surveillance. It also has positive impact on the infrastructure of domestic medical device regulation and development. In this paper, we will discuss the necessary procedures to train a clinical engineer to account for this need.The establishment of a certified ISO Guide 25 testing laboratory for medical devices is an important corner stone for a better national medical device management system and practices of the assorted standards or guidelines. It can also contribute significantly to the educational program for clinical engineer. As a starting point, a medical electrical safety-testing laboratory according to the AAMI ES-1 (1993) and IEC 60601 (1988) has been setup and devoted to the safety of electromedical apparatus with joined efforts of the Institute of Biomedical Engineering, National Taiwan University and Department of Biomedical Engineering, National Taiwan University Hospital. To ensure its quality of services, ISO/IEC Guide 25 is implemented and certified by Chinese National Laboratory Accreditation (CNLA). In view of the global harmonization, this painstaking procedure for a medical device-testing laboratory can be fruitful in the aspects of quality assurance for the imported devices and post-market surveillance. It also has positive impact on the infrastructure of domestic medical device regulation and development. In this paper, we will discuss the necessary procedures to train a clinical engineer to account for this need.