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X-ray blood irradiation device
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YY/T 1834-2022
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Basic data | Standard ID | YY/T 1834-2022 (YY/T1834-2022) | | Description (Translated English) | X-ray blood irradiation device | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 23,255 | | Issuing agency(ies) | State Drug Administration |
YY/T 1834-2022: X-ray blood irradiation device---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
X-ray blood irradiation device
ICS 11.040.50
CCSC43
People's Republic of China Pharmaceutical Industry Standard
X-ray blood irradiation equipment
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
5 Requirements 2
6 Test method 7
Appendix A (Normative) Ionization Chamber Method - Sample Container Absorbed Dose Uniformity 12
Appendix B (normative) Alanine Dosimeter - EPR Method - Sample Container Absorbed Dose Uniformity 14
Appendix C (Normative) Ionization Chamber Film Combination - Sample Container Absorbed Dose Uniformity 16
Reference 19
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.
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 Medical Device Inspection and Testing Institute, Medical Device Technology Review Center of the State Drug Administration, Zhejiang
Provincial Medical Device Evaluation Center, Guangdong Provincial Drug Administration Evaluation and Certification Center, Zhuhai Livzon Reagent Co., Ltd., Shandong Weigaoji
Tuan Medical Polymer Products Co., Ltd., Shandong Xinhua Medical Equipment Co., Ltd., Qingdao Jinchengyuan Medical Technology Co., Ltd.
The main drafters of this document. Wang Jing, Sun Zhiyong, Zhu Wenwu, Sun Zhigang, Wang Yue, Chen Zhuo, Dai Junying, Liu Bangyuan, Zhu Jiang, Yue Fangchao, Wang Dong,
Xu Xiang, Qin Yu, Zhang Chengbao, Jin Ye.
X-ray blood irradiation equipment
1 Scope
This document specifies the classification and composition, requirements and test methods of X-ray blood irradiation equipment.
This document applies to equipment that produces X-rays for blood irradiation.
2 Normative references
The contents of the following documents constitute 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/T 10149 Terms and Symbols of Medical X-ray Equipment
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
3 Terms and Definitions
GB/T 10149 and the following terms and definitions apply to this document.
3.1
A device that generates X-rays to irradiate blood and blood products.
3.2
sample container canister
A container used to hold bagged blood or blood products during X-ray irradiation.
[Source. ISO /ASTM51939.2017, Definition 3.2.2, with modifications]
3.3
According to the set X-ray irradiation conditions, irradiate the sample container loaded with blood, blood products or other equivalent media,
The absorbed dose value produced at the reference point of the sample container, in Gy.
[Source. ISO /ASTM51939.2017, 3.1.1, with modifications]
3.4
According to the set X-ray irradiation conditions, irradiate the sample container loaded with blood, blood products or other equivalent media,
The absorbed dose ratio produced at the reference point of the sample container, in units of Gy·s-1, Gy·min-1, Gy·h-1.
[Source. ISO /ASTM51939.2017, 3.1.2, with modifications]
3.5
Absorbed-dosemapping
Measure the absorbed dose value of the irradiated sample, form one-dimensional, two-dimensional or three-dimensional distribution of absorbed dose value, and obtain the distribution of absorbed dose value
Curve or distribution graph. For a certain sample container, the distribution of absorbed dose values can be obtained by a dosimeter placed at a specified position in the container
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