YY/T 1519-2017 (YY/T1519-2017, YYT 1519-2017, YYT1519-2017)
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Electrophysiology catheter
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YY/T 1519-2017
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Standards related to: YY/T 1519-2017
| Standard ID | YY/T 1519-2017 (YY/T1519-2017) | | Description (Translated English) | Electrophysiology catheter | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 8,897 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shanghai Medical Device Testing Institute, Shanghai Micro-invasive Electrophysiology Medical Technology Co., Ltd. | | Administrative Organization | National Medical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Technical Committee (SAC/TC 10/SC 5) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1519-2017
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
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