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YY/T 1519-2017 PDF English

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YY/T 1519-2017: Electrophysiology catheter
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YY/T 1519-2017150 Add to Cart Auto, 9 seconds. Electrophysiology catheter Valid

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YY/T 1519-2017: Electrophysiology catheter

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1519-2017
YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.60 C 39 Electrophysiology catheter Issued on: MARCH 28, 2017 Implemented on: APRIL 1, 2018 Issued by. China Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 5 4 Requirements ... 5 5 Test methods ... 8 Electrophysiology catheter

1 Scope

This Standard specifies the terms and definitions, requirements, test methods for electrophysiology catheter and connection cable. This Standard is applicable to the electrophysiology catheter specified in 3.1 (hereinafter referred to as the catheter) and connection cable (hereinafter referred to as the cable). For electrophysiological catheters with special functions and features, the manufacturer shall supplement the corresponding requirements.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 9706.1-2007, Medical electrical equipment - Part 1. General requirements for safety GB/T 14233.1-2008, Test methods for infusion transfusion injection equipment for medical use - Part 1. Chemical analysis methods GB/T 14233.2-2005, Test methods for infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods GB/T 16886.4-2003, Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity GB/T 16886.11-2011, Biological evaluation of medical devices - Part 11. Tests for systemic toxicity YY 0285.1-2004, Sterile, single-use intravascular catheters - Part 1. General requirements than 5 MΩ. 4.4 Chemical properties 4.4.1 Reducing substance The test solution is compared with the same volume and the same batch of blank control solution. The difference between the consumption of potassium permanganate solution [c(KMnO4)=0.002 mol/L] shall not exceed 2.0 mL. 4.4.2 Heavy metal The color of the test solution shall not exceed the standard control solution with a mass concentration of ρ(Pb2+)=1 μg/mL. 4.4.3 pH The pH of the test solution is compared with the same batch of blank control solution, and the difference between pH shall not exceed 1.5. 4.4.4 Evaporation residue In 50mL test solution, the total mass of non-volatiles shall not exceed 2 mg. 4.4.5 Ethylene oxide residue (if applicable) The residual amount of ethylene oxide shall be no more than 10 μg/g. 4.4.6 Ultraviolet absorbance When the test solution has a wavelength range of 250 nm to 320 nm, the absorbance shall be no more than 0.1. 4.4.7 Corrosion resistance After the corrosion test, the metal parts of the catheter shall not have corrosion marks. 4.5 Biological performance 4.5.1 Sterile Sterilized catheter shall be sterile. 4.5.2 Pyrogen The catheter shall be pyrogen free. 4.5.3 Cytotoxicity The chemical performance test liquid can be prepared by using only the material in the catheter that is in contact with the human body to prepare the test solution. Adopt the method of No. 2 in Table 1 of GB/T 14233.1-2008. If the finished catheter product is used for verification, the test solution shall be prepared by using the method without destroying the catheter, and immersed according to the method of No. 2 in Table 1 of GB/T 14233.1-2008. 5.4.1 Reducing substance When testing according to 5.2.2 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.1. 5.4.2 Heavy metal When testing according to 5.6.2 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.2. 5.4.3 pH When testing according to 5.4.1 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.3. 5.4.4 Evaporation residue When testing according to 5.5 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.4. 5.4.5 Ethylene oxide residue When testing according to 9 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.5. 5.4.6 Ultraviolet absorbance When testing according to 5.7 of GB/T 14233.1-2008, it shall meet the requirements of 4.4.6. 5.4.7 Corrosion resistance When testing according to Annex A of YY 0285.1-2004, it shall meet the requirements of 4.4.7. 5.5 Biological performance 5.5.1 Sterile According to the method in GB/T 14233.2-2005, the test results shall be sterile. 5.5.2 Pyrogen ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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