Path: Home > YY/T > Page27 > YY/T 1532-2017

Price & Delivery

US$279.00 · In stock · Download in 9 seconds
YY/T 1532-2017: Biological evaluation of medical devices - Nanomaterials - Hemolysis test
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid

Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1532-2017	English	279	Add to Cart	3 days [Need to translate]	Biological evaluation of medical devices - Nanomaterials - Hemolysis test

YY/T 1532-2017: Biological evaluation of medical devices - Nanomaterials - Hemolysis test

---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.
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) ...