Clinical Engineering Handbook 2020
DOI: 10.1016/b978-0-12-813467-2.00075-4
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Inspection of medical devices

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Cited by 14 publications
(10 citation statements)
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“…The novel methodology was developed based on OIML guidelines for technical and metrological characteristics and performance evaluation. Developed methodology has been validated by the work of two inspection bodies for medical devices working under the legal metrology framework which has been adopted for medical devices in Bosnia and Herzegovina and Republic of Serbia [13,14]. The introduction of standardized conformity assessment method for testing of safety and performance of ECG device produced traceable, accurate, complete, verified, nonbiased and standardized data.…”
Section: Discussionmentioning
confidence: 99%
“…The novel methodology was developed based on OIML guidelines for technical and metrological characteristics and performance evaluation. Developed methodology has been validated by the work of two inspection bodies for medical devices working under the legal metrology framework which has been adopted for medical devices in Bosnia and Herzegovina and Republic of Serbia [13,14]. The introduction of standardized conformity assessment method for testing of safety and performance of ECG device produced traceable, accurate, complete, verified, nonbiased and standardized data.…”
Section: Discussionmentioning
confidence: 99%
“…The novel methodology was developed based on OIML guidelines for technical and metrological characteristics and performance evaluation. Developed methodology has been validated by the work of two inspection bodies for medical devices working under the legal metrology framework which has been adopted for medical devices in Bosnia and Herzegovina and Republic of Serbia [13,14]. The introduction of standardized conformity assessment method for testing of safety and performance of patient monitors produced traceable, accurate, complete, verified, nonbiased and standardized data.…”
Section: Discussionmentioning
confidence: 99%
“…The novel methodology was developed based on OIML guidelines for technical and metrological characteristics and performance evaluation. Developed methodology has been validated by the work of two inspection bodies for medical devices working under the legal metrology framework which has been adopted for medical devices in Bosnia and Herzegovina and Republic of Serbia [15,16]. The introduction of standardized conformity assessment method for testing of safety and performance of infusion and perfusor pumps produced traceable, accurate, complete, verified, nonbiased and standardized data.…”
Section: Discussionmentioning
confidence: 99%