YY/T 1519-2017Electrophysiology catheter (English PDF)
电生理标测导管
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1519-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1519-2017 is the English-translated version of 电生理标测导管.
YY/T 1519-2017 is the Chinese pharmaceutical industry standard for the electrophysiology catheter and its connection cable, the catheter passed into the heart to record electrograms and to stimulate.
It gives the terms and definitions, the requirements and the test methods, covering the dimensions and the flexibility of the shaft, the electrodes and their spacing and impedance, the continuity and insulation of the conductors, the connector and the cable, the tensile strength of the assembly, the radiopacity, the materials and their biological evaluation, and sterility. Issued on 28 March 2017, it has applied since 1 April 2018.
Found what you need?
Document preview — YY/T 1519-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions5
- 4 Requirements5
- 5 Test methods8
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 Mohm.
4 Requirements
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 rho(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 Test methods
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.4-2003Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- GB/T 16886.5-2003Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- GB/T 16886.10-2005Biological evaluation of medical devices - Part 10: Tests for skin sensitization
How to Download YY/T 1519-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
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
YY 0285.1-2004 — Sterile, single-use intravascular catheters - Part 1: General requirements
Secure payment via Stripe
Payments accepted
YY/T 1519-2017
$125.00