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YY/T 0848-2011 English PDF

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YY/T 0848-2011: Blood irradiator
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 0848-2011229 Add to Cart 3 days Blood irradiator Valid

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Basic data

Standard ID: YY/T 0848-2011 (YY/T0848-2011)
Description (Translated English): Blood irradiator
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.99
Word Count Estimation: 10,139
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB 4793.1; GB 9706.1; GB/T 14710
Regulation (derived from): State Food and Drug Administration Notice No. 106 of 2011
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the scope of blood irradiation apparatus, requirements and test methods. This standard applies to ��-ray source of blood irradiation apparatus (hereinafter referred to as irradiation apparatus). Irradiation apparatus for medical purposes on blood samples irradiated.

YY/T 0848-2011: Blood irradiator

---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.
Blood irradiator ICS 11.040.99 C43 People's Republic of China pharmaceutical industry standards Blood irradiator Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee appliances medical radiotherapy, nuclear medicine science equipment at the Technical Committee and the radiation dose (SAC/TC10/SC3) centralized. This standard was drafted. Beijing Medical Device Testing, the State Food and Drug Administration Medical Device Evaluation Center, Wenzhou Geng Health Medical Equipment Co., Ltd., China Nuclear Power Institute of equipment factory, Shandong Xinhua Medical Instrument Co., Ltd. The main drafters of this standard. Chen Jing, Wang Peichen, on a sort Jinyun Qing, Fanzu Qing, Zhang Cheng Bao. Blood irradiator

1 Scope

This standard specifies the scope of blood irradiator, requirements and test methods. This standard applies to γ-ray source of blood irradiator (hereinafter referred to as the irradiator). Irradiator used for medical purposes blood sample Irradiation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety GB/T 14710 medical electrical environmental requirements and test methods

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Sample container canister A container during irradiation for loading blood or blood products equivalent, usually made of aluminum or steel. [ISO /ASTM51939.2005, the definition 3.1.7] 3.2 Reference point dose referencepointdose In the sample container at the reference point, the absorbed dose of ionizing radiation in the blood or other equivalent medium.

4 Requirements

4.1 random file Random file must contain at least the following. a) irradiator normal operating conditions (ambient temperature, humidity, atmospheric pressure); b) radioactive source parameters, including the name of radioactive sources, radioactive radiation type, half-life, energy radiation sources, radioactive geometrical characteristics; c) irradiator to meet the requirements of this standard maximum source activity radionuclides; d) source activity calibration information and calibration date; e) Replacement of sealed radioactive sources; f) sample container specifications and dose distribution; g) a list of the safety device on all interlocks and radiation and their descriptions, inspection instructions and recommended its operation with the Tests Cycle; h) When using the irradiator required dimension drawings;
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