YY 0778-2018: Radio frequency ablation catheter

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Scope

This Standard specifies the terms and definitions, requirements and test methods of radio
frequency ablation catheter.
This Standard is applicable to surgical accessories used as high-frequency surgical equipment,
catheters that can transmit radio frequency energy to target tissues through blood vessels and
lumens, and perform cutting and ablation of target tissues, hereinafter referred to as catheters.

Basic Data

Standard ID	YY 0778-2018 (YY0778-2018)
Description (Translated English)	Radio frequency ablation catheter
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C42
Classification of International Standard	11.040.60
Word Count Estimation	10,140
Date of Issue	2018-12-20
Date of Implementation	2020-06-01
Older Standard (superseded by this standard)	YY 0778-2010
Quoted Standard	GB/T 1962.2-2001; GB 9706.1; GB 9706.4-2009; GB 9706.19-2000; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 16886.1; YY 0285.1-2017
Regulation (derived from)	State Drug Administration Announcement No. 97 of 2018
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the terms and definitions, requirements, and test methods for radiofrequency ablation catheters. This standard is applicable to surgical accessories that are used as high-frequency surgical equipment. It can transmit radiofrequency energy to the target tissue through blood vessels and lumens, and implement a catheter for cutting and ablation of the target tissue, hereinafter referred to as a catheter.