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YY/T 1834-2022X-ray blood irradiation device (English PDF)

X射线血液辐照设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2023

Scope

YY/T 1834-2022 is the English-translated version of X射线血液辐照设备.

YY/T 1834-2022 is the Chinese pharmaceutical industry standard for X-ray blood irradiation equipment, the machine that irradiates blood components before transfusion to prevent transfusion-associated graft-versus-host disease.

It gives the classification and composition of the equipment, the requirements and the test methods, covering the dose delivered to the blood and its uniformity across the container, the timer and the dose indication, the shielding and radiation protection, the interlocks and the accompanying documents.

It applies to equipment that produces X-rays for blood irradiation. Issued on 18 May 2022, it has applied since 1 June 2023.

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Document preview — YY/T 1834-2022

National Standard of the People's Republic of China

Classification: C 43

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Classification and composition
5 Requirements
6 Test method
Appendix A (Normative) Ionization Chamber Method - Sample Container Absorbed Dose Uniformity
Appendix B (normative) Alanine Dosimeter - EPR Method - Sample Container Absorbed Dose Uniformity
Appendix C (Normative) Ionization Chamber Film Combination - Sample Container Absorbed Dose Uniformity
Reference

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.

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.

3.2 Sample container canister

A container used to hold bagged blood or blood products during X-ray irradiation. [Source: ISO /ASTM 51939:2017, 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 /ASTM 51939:2017, 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 /ASTM 51939:2017, 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

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