YY/T 1519-2017 Active Industry standards-Medicine

YY/T 1519-2017 Electrophysiology catheter

YY/T 1519-2017 Electrophysiology catheter

Publish Date: 2017-03-28 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1519-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: Treatment equipment

Publish Date: 2017-03-28

Implement Date: 2018-04-01

Pages: 8 pages

Scope

This standard specifies the terms and definitions, requirements, and test methods for electrophysiological mapping catheters and connecting cables.
This standard applies to the electrophysiological mapping catheters defined in 3.1 (hereinafter referred to as "catheters") and connecting cables (hereinafter referred to as "cables"). For manufacturers of electrophysiological mapping catheters with special functions and characteristics, corresponding requirements should be added.

Development Information

Word Count: 14 Thousand words Pages: 8 pages

Referenced Standards

GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments 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 YY 0778-2010 Radio frequency ablation catheter

Related Standards

GB 12259-1990 Abolished

GB 12259-1990 Artificial heart-lung machine

Publish Date: 1990-01-08

GB 12261-1990 Abolished

GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator

Publish Date: 1990-01-08

GB 12262-1990 Abolished

GB 12262-1990 Artificial heart-lung machine—Heat exchanger

Publish Date: 1990-01-08

GB 2024-1994 Replaced

GB 2024-1994 Acupuncture needles

Publish Date: 1994-04-12

GB 10035-1994 Replaced

GB 10035-1994 The air-bag type sequential external counter-pulsation device

Publish Date: 1994-07-06

GB 16174.1-1996 Replaced

GB 16174.1-1996 Cardiac pacemakers—Part 1:Implantable pacemakers

Publish Date: 1996-03-07