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YY/T 0860-2024: Radio frequency ablation instrument for cardiac application
Status: Valid YY/T 0860: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0860-2024 | English | 279 |
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Radio frequency ablation instrument for cardiac application
| Valid |
YY/T 0860-2024
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| YY 0860-2011 | English | 479 |
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Radio frequency ablation instrument for cardiac application
| Obsolete |
YY 0860-2011
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PDF similar to YY/T 0860-2024
Standard similar to YY/T 0860-2024 YY 0778 YY 0950 YY 0900 YY/T 0323 YY/T 0868 Basic data | Standard ID | YY/T 0860-2024 (YY/T0860-2024) | | Description (Translated English) | Radio frequency ablation instrument for cardiac application | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 14,117 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 0860-2011 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the classification and requirements of cardiac radiofrequency ablation treatment equipment and its accessories, and specifies the corresponding test methods. This standard applies to cardiac radiofrequency ablation treatment equipment and its accessories, which are used for cardiac interventional radiofrequency ablation surgery or cardiac/thoracic surgery radiofrequency ablation surgery. | YY/T 0860-2024: Radio frequency ablation instrument for cardiac application---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.60
CCSC42
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0860-2011
Cardiac radiofrequency ablation equipment
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Categories 1
5 Requirement 2
6 Test methods 4
References 7
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 0860-2011 "Cardiac Radiofrequency Ablation Therapy Equipment". Compared with YY/T 0860-2011, except for the structural adjustment
In addition to editorial changes, the main technical changes are as follows.
--- Changed the description of the scope (see Chapter 1, Chapter 1 of the.2011 edition).
--- Changed the definition of cardiac radiofrequency ablation therapy equipment (see 3.1, 3.1 of the.2011 edition);
--- Deleted the terms and definitions of temperature control and power control (see 3.2 and 3.3 of the.2011 edition);
--- Added classification (see Chapter 4);
--- Deleted the composition (see Chapter 4 of the.2011 edition);
--- Deleted working conditions (see 5.1 of the.2011 edition);
--- Changed the operating frequency requirements (see 5.1.1, 5.2.1 of the.2011 edition);
--- Changed the requirements and test methods for RF output power (see 5.1.2, 6.2.2, 5.2.2, 6.3.2 of the.2011 edition);
--- Changed the requirements and test methods for impedance display function (see 5.1.3, 6.2.3, 5.2.3, 6.3.3 of the.2011 edition);
--- Changed the requirements and test methods for temperature display function (see 5.1.4, 6.2.4, 5.2.4, 6.3.4 of the.2011 edition);
--- Deleted the requirements and test methods for temperature control range and error (see 5.2.5 and 6.3.5 of the.2011 edition);
--- Changed the requirements and test methods for timing function (see 5.1.5, 6.2.5, 5.2.6, 6.3.6 of the.2011 edition);
--- Added requirements and test methods for protection functions (see 5.1.6, 6.2.6);
--- Changed the manual stop function requirements (see 5.1.8, 5.2.7 of the.2011 edition);
--- Added requirements and test methods for priming pumps (see 5.2, 6.3);
--- Deleted the requirements and test methods for biocompatibility of neutral electrodes (see 5.4 and 6.5 of the.2011 edition);
--- Added requirements and test methods for accessories for cardiac surgery radiofrequency ablation (see 5.4, 6.5);
--- Deleted the safety requirements, electromagnetic compatibility requirements and test methods (see 5.6, 5.7, 6.7, 6.8 of the.2011 edition);
--- Changed the requirements for environmental testing (see 5.7, 5.8 of the.2011 edition);
--- Deleted the requirements for marking, instruction manual, packaging, transportation and storage (see Chapter 7 and Chapter 8 of the.2011 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the Physical Therapy Equipment Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC4).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Medical Device Inspection Institute, Johnson & Johnson (Shanghai) Medical
Medical Equipment Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Beijing Bairen Medical Technology Co., Ltd., Sichuan Jinjiang Electronic Medical Devices
Machinery Technology Co., Ltd.
The main drafters of this document are. Zhang Longfei, Liu Bo, Sun Huili, Li Yanan, Xu Wei, Hong Wei, Lu Lingfeng, Shan Ying, Tan Xiaoliu, Suo Yinhu,
Zhang Xiaohua.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2011 as YY 0860-2011;
---This is the first revision.
Introduction
The products specified in this document shall comply with YY 0650 and applicable GB 9706.1 and GB 9706.202, and will not be repeated in this document.
Repeat request.
Cardiac radiofrequency ablation equipment
1 Scope
This document specifies the classification and requirements of cardiac radiofrequency ablation equipment (hereinafter referred to as equipment) and its accessories, and describes the corresponding test
Test method.
This document applies to cardiac radiofrequency ablation treatment equipment and its accessories. This type of equipment is used for cardiac interventional radiofrequency ablation surgery or heart/chest
Surgical radiofrequency ablation procedure.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB 9706.202 Medical electrical equipment Part 2-2.Basic safety and essential performance of high-frequency surgical equipment and high-frequency accessories
Require
GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 16886.7 Biological evaluation of medical devices Part 7.Ethylene oxide sterilization residues
YY 0650 General technical requirements for radiofrequency ablation treatment equipment
YY 0778 Radiofrequency ablation catheter
YY/T 1057 General technical requirements for medical foot switches
3 Terms and definitions
The terms and definitions defined in GB 9706.1, GB 9706.202 and YY 0650 and the following terms and definitions apply to this document.
3.1
Used in conjunction with cardiac radiofrequency ablation surgery accessories, it uses the thermal effect of high-frequency current to ablate target cardiac tissue.
Technical equipment.
4 Categories
Cardiac radiofrequency ablation treatment equipment is divided into cardiac interventional radiofrequency ablation equipment and cardiac surgical radiofrequency ablation equipment.
Cardiac interventional radiofrequency ablation equipment is used in conjunction with cardiac radiofrequency ablation catheters. During cardiac interventional surgery, the ablation catheter enters the heart through the blood vessels.
The device uses the thermal effect of high-frequency current to ablate the target cardiac tissue from the inside of the heart. Some devices are also used in conjunction with perfusion pumps.
Cardiac surgery radiofrequency ablation equipment is used in conjunction with cardiac surgery radiofrequency ablation forceps/pen and other surgical accessories.
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