ISO 13304:2020

Description

The purpose of this document is to provide minimum criteria required for quality assurance and quality control, evaluation of the performance and to facilitate the comparison of measurements related to absorbed dose estimation obtained in different laboratories applying ex vivo X-band EPR spectroscopy with human tooth enamel.

This document covers the determination of absorbed dose in tooth enamel (hydroxyapatite). It does not cover the calculation of dose to organs or to the body.

This document addresses:

a) responsibilities of the customer and laboratory;

b) confidentiality and ethical considerations;

c) laboratory safety requirements;

d) the measurement apparatus;

e) preparation of samples;

f) measurement of samples and EPR signal evaluation;

g) calibration of EPR dose response;

h) dose uncertainty and performance test;

i) quality assurance and control.