The B3 dosimeter product should be tested against expected performance criteria as part of a dosimeter measurement system (dosimetry system).
|
Performance verification interval |
Performance verification of the B3 dosimeter measurement system is completed during qualification, and at user-defined intervals based on risk assessment as part of routine use of the system. General Characteristics of B3 Film - Consider all influence quantities that might affect absorbed dose measurements. Operational Qualification & Performance Verification of the dosimetry system, including Measurement Instruments - Prior to conducting performance characterization of the dosimeters, it is necessary to establish procedures for the operation of the measurement instruments |
|
Industry guidance |
ASTM 52628, ASTM 51275, ASTM 52701 |
|
GEX recommendations |
The user is responsible for defining and writing the protocols for dosimeter characterization and performance verification activities. |
Disclaimer - The information contained in this document is provided “as is” and is not a substitute for the user’s professional judgement. It is provided as a convenience to those using products provided by GEX Corporation who have sufficient technical skills to evaluate and properly apply the information in this document. It is the responsibility of the user of this document to ensure that the information in this document, and the use of such information, is accurate, complete, applicable to the product, suitable for the user’s purposes, and in compliance with all laws and regulations. GEX Corporation believes the information provided in this document is accurate and reliable as of the time of writing, but it undertakes no obligation to update or correct this document. GEX Corporation may, but is not required to, make changes to this document at any time without notice. By using the information in this document, the user represents and warrants that he or she has the skills necessary to properly understand and apply this information and that he or she will comply with all applicable laws and regulations including, without limitation, those relating to medical devices, pharmaceutical products, or other applicable industries. The user assumes all risks associated with using this information and any results or output resulting from the application of this information to GEX Corporation’s products. The user agrees not to hold GEX Corporation liable for any errors or omissions contained within.