YY 0778-2018 English PDF (YY0778-2018)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY 0778-2018 (Self-service in 1-minute)
Historical versions (Master-website): YY 0778-2018
Preview True-PDF (Reload/Scroll-down if blank)

YY 0778-2018: Radio frequency ablation catheter
YY 0778-2018
(Radiofrequency ablation catheter)
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0778-2010
Radiofrequency ablation catheter
Published on.2018-12-20
2020-06-01 implementation
State Drug Administration issued
Content
Foreword I
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 4
Appendix A (Normative Appendix) Bending fatigue test method 7
Foreword
The full technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0778-2010 "radio frequency ablation catheter", compared with YY 0778-2010, the main changes are as follows.
--- Revised the definition of radiofrequency ablation catheter (see 3.1, 3.1 of.2010);
---Modified the requirements for breaking force (see 4.2.2,.2010 edition 4.2.2);
--- Increased the requirements for Luer joints (see 4.2.5);
--- Modified biological performance (see 4.4, 4.4 of.2010 edition);
--- Added special requirements for cardiac radiofrequency ablation catheters (see 4.6);
---Modified security requirements (see 4.7, 4.6 of.2010 edition);
--- Removed the requirements of the instruction manual (see 4.7 of.2010 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Mini-invasive Electrophysiology Medical Technology Co., Ltd.
The main drafters of this standard. Liu Bo, Li Yanan, Duan Qiaofeng.
The previous versions of the standards replaced by this standard are.
---YY 0778-2010.
Radiofrequency ablation catheter
1 Scope
This standard specifies the terms and definitions, requirements, and test methods for radiofrequency ablation catheters.
This standard is applicable to surgical accessories as a high-frequency surgical device. It can transmit radio frequency energy to the target tissue through blood vessels and lumens.
The target tissue is a catheter for cutting and ablation, hereinafter referred to as a catheter.
2 Normative references
The following documents are indispensable for the application of this document. 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 1962.2-2001 Syringes, needles and other medical devices 6% (Ruhr) conical joints. Part 2. Locking joints
(ISO 594-2.1998, IDT)
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.4-2009 Medical electrical equipment - Part 2-2. Particular requirements for safety of high-frequency surgical equipment (IEC 60601-2-2.
2006, IDT)
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for safety of endoscopes
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 14233.2-2005 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
YY 0285.1-2017 single-use sterile catheters - Part 1 . General requirements
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 and GB 9706.4-2009 apply to this document.
3.1
Radiofrequency ablation catheter radiofrequencyablationcatheter
As a surgical accessory for high-frequency surgical equipment, it can transmit RF energy to the target tissue through blood vessels and lumens, and implement the target tissue.
Catheter for cutting and ablation.
4 requirements
4.1 External markup
The manufacturer shall give at least the following information on each product package.
a) product name;
b) outer diameter;
c) effective length;
d) the manufacturer's name or registered trademark and address;
e) production batch number;
f) expiration date or use deadline;