This activity may be performed prior to purchase and receipt of this product. GEX Customer Support assists customers in gathering the information necessary, as needed.
Before first use of the product, determine and implement the practices and procedures necessary between purchase and disposal of the product to control the performance within the quality limits required. Controls required vary by application. This should include mitigation actions for influence quantities (use case factors that may affect measurement accuracy or uncertainty) to ensure the product will perform within a normally expected range for the use cases to be encountered in the application. See - General Characteristics of B3 Film Dosimeters.
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Does product or system need to be qualified prior to routine use? |
Yes. The B3 dosimeter product should be qualified as part of a dosimeter measurement system (dosimetry system). Dosimeter/dosimetry system characterization is conducted to determine the performance characteristics for a dosimeter/dosimetry system related to its capability for measuring absorbed dose. |
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Industry guidance |
ASTM 52628, ASTM 51275, ASTM 52701 |
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GEX recommendations |
The user is responsible for defining the qualification activities necessary to fulfill the user’s measurement management system (i.e. dosimetry system) and quality system requirements. See ISO 10012 or ISO 9001, or other relevant guidelines specific to the end-user’s application and process. GEX recommends that users qualify the entire process of dosimetry from dosimeter provision to placement in the irradiator, dosimeter retrieval, dosimeter heat treatment, dosimeter sample measurement, data analysis, and reporting to the extent required by the application for which the dosimetry system will be used. |
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.