YY/T 1827.1-2022Medical electrical equipment-Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy (English PDF)

1 Scope

This document specifies the minimum data set for reporting information related to dosimetry and the generation of radiation images, the Radiation Dose Structured Report (RD-

SR) information unit, quantity and data storage format.

This document applies to the radiation dose results generated by X-ray equipment within the scope of GB 9706.243 or GB 9706.254.

Structured report.

NOTE 1 The purpose of this document is to develop and publish similar documents for other X-ray imaging equipment capable of generating Radiation Dose Structured Reports (RDSRs).

for reference.

Note 2.This document does not prescribe specific requirements for the accuracy of reported or displayed data.

Note 3.The specific data format is specified because the uncertainty value of this data format may be smaller than that of other data formats.

Note 4.This document does not provide for the operator or other personnel to display the form of dose information to prescribe.

Note 5 to entry. The data fields and reporting structure are intended for use in the collection of dosimetry data for. significant radiation dose program management, equipment quality planning, building

Establish reference level and teaching.

Note 6.The open data structure is conducive to the data analysis of relevant organizations and institutions.

2 Normative references

The content of the following documents constitutes essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance (GB 9706.1-2020,

IEC 60601-1.2012, MOD)

GB 9706.103 Medical Electrical Equipment Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standard. Diagnosis X

Radiation protection of radiation equipment (GB 9706.103-2020, IEC 60601-1-3.2013, MOD)

GB 9706.243 Medical Electrical Equipment Part 2-43.Special Requirements for Basic Safety and Basic Performance of Interventional X-ray Equipment

Seek (GB 9706.243-2021, IEC 60601-2-43.2017, MOD)

GB 9706.254 Medical Electrical Equipment Part 2-54.Special for basic safety and basic performance of X-ray photography and fluoroscopy equipment

Requirements (GB 9706.254-2020, IEC 60601-2-54.2018, MOD) ofdefinedterms)

3 Terms and Definitions

GB 9706.1, GB 9706.103, GB 9706.243, GB 9706.254, IEC /T R60788.2004 and the following terms

Definitions apply to this document.