ASTM/ISO 51400-03

4.1 The radiation industry needs reliable, prompt dosimetry calibration services to support accurate measurements of absorbed dose. These measurements should be consistent with, and traceable to, the physical measurement standards maintained by an appropriate national or international standards laboratory. Organizations that provide calibration services, and thereby serve as a link to national standards, include universities, government-owned laboratories, and private companies.

4.2 To ensure the provision of adequate services, a calibration laboratory should be operating with a full measurement quality assurance (MQA) plan. The fundamental requirements for such a program include:

4.2.1 compliance with operational requirements of this practice and those of ISO/IEC 17025,

4.2.2 documented procedures and in-house quality assurance (QA) program specific to the calibration services provided, and

4.2.3 periodic performance evaluations, including proficiency tests and on-site expert assessments.5

4.3 When a calibration laboratory applies for accreditation, the accreditation organization (see Annex A1) determines whether the laboratory's quality documentation is satisfactory, performs proficiency tests for each calibration category for which accreditation is requested, and provides technical experts for on-site assessments to determine whether the laboratory meets the criteria of this practice, the accreditation organization and those of ISO/IEC 17025.

4.4 Section 5 sets forth specific criteria for laboratories engaged in dosimetry calibrations involving ionizing radiation, that is, gamma-radiation, electron beams and X-radiation (bremsstrahlung) beams. This section amplifies and interprets the general requirements of ISO/IEC 17025.

1.1 This practice addresses the specific requirements for laboratories engaged in dosimetry calibrations involving ionizing radiation, namely, gamma-radiation, electron beams or X-radiation (bremsstrahlung) beams. It specifically describes the requirements for the characterization and performance criteria to be met by a high-dose radiation dosimetry calibration laboratory.

1.2 The absorbed-dose range is typically between 10 and 10 Gy.

1.3 This practice addresses criteria for laboratories seeking accreditation for performing high-dose dosimetry calibrations, and is a supplement to the general requirements accreditation organization.

1.3.1 By meeting these criteria dn those in ISO/IEC 17025, the laboratory may be accredited by a recognized accreditation organization.

1.3.2. Adherence to these criteria will help to ensure high standards of performance and instill confidence regarding the competency of the accredited laboratory with respect to the services it offers.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and healthy practices and determine the applicability of regulatory limitations prior to use.