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YY/T 1827.1-2022: Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
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Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
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YY/T 1827.1-2022
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Basic data | Standard ID | YY/T 1827.1-2022 (YY/T1827.1-2022) | | Description (Translated English) | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 27,244 | | Issuing agency(ies) | State Drug Administration | YY/T 1827.1-2022: Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
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Medical electrical equipment - Radiation dose documentation - Part 1.Radiation dose structured reports for radiography and radioscopy
ICS 11.040.50
CCSC43
People's Republic of China Pharmaceutical Industry Standard
Medical Electrical Equipment Radiation Dose Documentation
Part 1.Radiation doses from photographic and fluoroscopic equipment
structured reporting
(IEC 61910-1.2014, MOD)
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Units and their DICOM storage format 2
5 General Requirements 2
Appendix A (Informative) General Guidelines and Rationale 6
Appendix B (Informative) DICOM and IHE Abstracts8
Appendix C (Informative) DICOM Data Element Glossary 10
Appendix D (Informative) Coordinate Systems and Their Applications 14
Appendix E (Informative) Geometry and Posture in DICOM 16
Reference 20
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 1 of YY/T 1827 "Medical Electrical Equipment Radiation Dose Document". YY/T 1827 has issued the following
part.
--- Part 1.Structured reporting of radiation doses for photographic and fluoroscopic equipment.
This document uses the redrafted method to modify and adopt IEC 61910-1.2014 "Medical Electrical Equipment Radiation Dosage Document Part 1.Photography
Structured Reporting of Radiation Dose for Imaging and Fluoroscopy Equipment.
The technical differences between this document and IEC 61910-1.2014 and their reasons are as follows.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Replacing IEC 60601-1 with GB 9706.1 modified to adopt international standards;
● Replacing IEC 60601-3 with GB 9706.103 which has been modified to adopt international standards;
● Replacing IEC 60601-2-43 with GB 9706.243 which is modified to adopt international standard;
● Replace IEC 60601-2-54 with GB 9706.254 which has been modified to adopt the international standard.
The following editorial changes have been made to this document.
--- Deleted the words "replacement" and "addition" in the normative reference document;
--- For the part taken from DICOM and IHE in Appendix B, the column item symbol "---" is added to illustrate;
--- Deleted the term index of the International Standard.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/
SC1) focal point.
This document is drafted by. Liaoning Provincial Institute of Medical Device Inspection, Canon Medical Systems (China) Co., Ltd., Shanghai Siemens Medical Devices
Equipment Co., Ltd., Stryker (Beijing) Medical Equipment Co., Ltd., Shanghai Sidi Biomedical Technology Co., Ltd.
The main drafters of this document. Jin Yubo, Li Wei, Cao Jingtai, Zhang Futao, Jin Di, Zhao Jiayang, Liu Congzhi.
Introduction
In the process of radiological medical examination, the document recording the amount of ionizing radiation is of great significance in many aspects. On the one hand, radiation safety for the public
Comprehensive risk assessment provides data; on the other hand, the data provided by the radiation dose file, for the radiation dose reference level determined by the public agency
Performance verification of the radios also plays an important role; at the same time, by incorporating detailed documentation of radiation doses into the clinical management of patients undergoing interventional procedures,
It also plays an important role in reducing possible radiation risks.
As imaging technology transitions from film to digital, enabling the automatic recording of radiation doses and other data along with the image provides the possibility of
can. Although the early DICOM protocol provided some recording methods in the image file header, it also had some shortcomings, the biggest one being the lack of
There is no way to record dose data when images are not stored, e.g. fluoroscopic images are rarely stored; thus, if images are not stored, dose
The data is not stored.
In response to this problem, the IEC and DICOM committees jointly established a dose document working group, and in.2005 issued a supplement to the DICOM document
File Supplement94, and incorporated into DICOM files after.2006.DICOM file for recording a single imaging
The total radiation dose of the process provides a new technical format, this document is the 1st edition of the IEC 61910-1 standard, replacing the previously issued public technical format.
Technical file (PAS), and can be used as a supporting file for GB 9706.243 and GB 9706.254.
YY/T 1827 is intended to consist of the following parts.
--- Part 1.Structured reporting of radiation doses for photographic and fluoroscopic equipment.
This document defines the reporting information related to radiation dose and establishes the compliance level of the dose document to meet the requirements of the above document.
The compliance level takes into account the increased risk to patients and the ever-improving requirements for imaging quality control, and the compliance level for basic dose documentation applies
Extended dose documentation compliance level for x-ray equipment that produces radiation doses below the significant damage threshold for all intended uses
Applicable to X-ray equipment where the radiation dose in the examination may cause significant radiation damage. Appendix A gives further information.
A summary of the above work is as follows. The information is all integrated in the Radiation Dose Structured Report (RDSR). This new object is designed as
Stored in the Image Transmission and Archiving System (PACS), or in a medical information system, or in a stand-alone dose management workstation
on, or in the X-ray device itself. An examination step performed (which produces a separate RDSR file) corresponds to the
One examination performed by one patient on one device. Data structure allows transfer of all examination data at once or transfer of each radiation individually
event information. The Radiation Exposure Monitoring (REM) scheme of the Integrated Medical Information System (IHE) is given to realize the DICOM radiation dose structure
The IT architecture for the generation, storage, analysis, and distribution of RDSR objects (including reporting to superiors). Appendix B gives further
Information.
Medical Electrical Equipment Radiation Dose Documentation
Part 1.Radiation doses from photographic and fluoroscopic equipment
structured reporting
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.
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