YY 0765.1-2009Single-use materials for virus inactivation of blood and blood components - Part 1: Methylene blue virus inactivation materials (English PDF)
一次性使用血液及血液成分病毒灭活器材 第1部分：亚甲蓝病毒灭活器材
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY 0765.1-2009 is the English-translated version of 一次性使用血液及血液成分病毒灭活器材 第1部分：亚甲蓝病毒灭活器材.
YY 0765.1 covers the single-use materials used to inactivate viruses in plasma by the methylene blue and light method, the pathogen reduction technique used widely in Chinese blood services.
Methylene blue is added to plasma, illuminated, and then removed by a filter: the dye damages viral nucleic acid, and the filter has to take the dye back out before the plasma is transfused.
This standard sets the requirements for that kit and the test methods that verify them, covering the dye dose, the illumination, the removal filter and its efficiency, the effect on plasma proteins and coagulation factors, and the sterility. Being a YY standard without the /T suffix, compliance is compulsory in China.
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Document preview — YY 0765.1-2009
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C31
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This document was issued on 30 December 2009 by the National Medical Products Administration and takes effect on 1 June 2011.
It is a YY standard without the /T suffix: compliance is mandatory in China.
It is classified under ICS 11.040.20, Chinese classification C31.
1 Scope
YY 0765.1 covers the single-use materials used to inactivate viruses in plasma by the methylene blue and light method, the pathogen reduction technique used widely in Chinese blood services. Methylene blue is added to plasma, illuminated, and then removed by a filter: the dye damages viral nucleic acid, and the filter has to take the dye back out before the plasma is transfused. This standard sets the requirements for that kit and the test methods that verify them, covering the dye dose, the illumination, the removal filter and its efficiency, the effect on plasma proteins and coagulation factors, and the sterility. Being a YY standard without the /T suffix, compliance is compulsory in China.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 43 pages — is available in the English PDF.
Referenced standards
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