YY/T 1532-2017 (YY/T1532-2017, YYT 1532-2017, YYT1532-2017) & related versions
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Biological evaluation of medical devices—Nanomaterials—Hemolysis test
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YY/T 1532-2017: PDF in English (YYT 1532-2017)
YY/T 1532-2017
Biological evaluation of medical devices-Nanomaterials-Hemolysis test
ICS 11.040.30
C30
People's Republic of China pharmaceutical industry standards
Biomedical evaluation of nanomaterials in medical devices
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the China Institute of Food and Drug Control centralized.
This standard drafting unit. China Food and Drug Administration, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection
center.
The main drafters of this standard. Shao An Liang, Xu Liming, Yang Lifeng, Ke Jun, Guo Huan, Yang Wenrun, Xu Jianxia.
Biomedical evaluation of nanomaterials in medical devices
1 Scope
This standard specifies the direct/indirect contact with the blood of nano-materials and the combination of nano-materials in medical devices hemolytic performance test
method.
This standard applies to direct/indirect contact with the blood of nano-materials and the combination of medical devices in the free or release of nano-materials dissolved
Blood performance evaluation.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and test in risk management process (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Interaction with blood test selection (GB/T 16886.4-
2003, ISO 10993-4.2002, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12-
2005, ISO 10993-12.2002, IDT)
3 Terms, definitions and abbreviations
3.1 Terms and definitions
GB/T 16886.1, GB/T 16886.4 as defined in the following terms and definitions apply to this document.
3.1.1
Methemoglobin methemoglobin
Iron atoms have been oxidized to high ferric ion hemoglobin.
3.1.2
Cyanide methemoglobin cyanmethemoglobin
Iron atoms are oxidized to high-iron ions, high-speed iron ions have been combined with cyanide hemoglobin.
3.1.3
Total hemoglobin total hemoglobin
All hemoglobin derivatives normally present in human circulating blood include deoxyhemoglobin, oxyhemoglobin, hemoglobin hemoglobin
White, carboxyhemoglobin and methemoglobin.
3.2 Abbreviations
The following abbreviations apply to this document.
Cal. Calibration Standard
CMH. Cyanmethemoglobin
DPBS. Dulbecco's phosphate-free phosphate buffer (Dulbercco's Phosphate Buffered Saline)
......
| Standard ID | YY/T 1532-2017 (YY/T1532-2017) | | Description (Translated English) | Biological evaluation of medical devices--Nanomaterials--Hemolysis test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 14,135 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | China Institute of Food and Drug Control, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center | | Administrative Organization | China Institute of Food and Drug test | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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