YY/T 1519-2017 English PDF (YYT1519-2017)
YY/T 1519-2017 English PDF (YYT1519-2017)
YY/T 1519-2017: Electrophysiology catheter
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
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.
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
Sterilized catheter shall be sterile.
The catheter shall be pyrogen free.
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.
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
According to the method in GB/T 14233.2-2005, the test results shall be sterile. 5.5.2 Pyrogen