YY/T 0860-2024 Active Industry standards-Medicine

YY/T 0860-2024 Radio frequency ablation instrument for cardiac application

YY/T 0860-2024 Radio frequency ablation instrument for cardiac application

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0860-2024
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name: Treatment equipment
Publish Date: 2024-09-29
Implement Date: 2025-10-15
Pages: 16 pages

Scope

This document specifies the classification and requirements of cardiac radiofrequency ablation therapy equipment (hereinafter referred to as the equipment) and its accessories, and describes the corresponding test methods.
This document applies to cardiac radiofrequency ablation therapy equipment and its accessories. This type of equipment is used in cardiac interventional radiofrequency ablation surgery or cardiac/thoracic surgery radiofrequency ablation surgery.

Development Information

Word Count: 17 Thousand words Pages: 16 pages

Replace the following standards

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals YY 0650-2008 Gynecological radio frequency therapy instrument YY 0650-2022 General technical requirements for radio frequency ablation equipment YY 0778-2010 Radio frequency ablation catheter YY 0778-2018 Radio frequency ablation catheter YY/T 1057-2016 General specifications for medical foot switch YY 1057-2016 General specifications for medical foot switch GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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