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YY/T 0776-2023 English PDF

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YY/T 0776-2023: Radio frequency ablation equipment for liver
Status: Valid

YY/T 0776: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0776-2023English219 Add to Cart 3 days [Need to translate] Radio frequency ablation equipment for liver Valid YY/T 0776-2023
YY 0776-2010English559 Add to Cart 3 days [Need to translate] Radio frequency ablation instrument for liver Obsolete YY 0776-2010

PDF similar to YY/T 0776-2023


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Basic data

Standard ID YY/T 0776-2023 (YY/T0776-2023)
Description (Translated English) Radio frequency ablation equipment for liver
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 10,173
Date of Issue 2023-06-20
Date of Implementation 2025-07-01
Older Standard (superseded by this standard) YY/T 0776-2010
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements and test methods for liver radiofrequency ablation therapy equipment and its accessories. This standard applies to liver radiofrequency ablation therapy equipment and its accessories.

YY/T 0776-2023: Radio frequency ablation equipment for liver

---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 0776-2010 Liver radiofrequency ablation treatment equipment Published on 2023-06-20 2025-07-01 Implementation Released by the State Drug Administration

Table of contents

PrefaceⅠ 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 4

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY 0776-2010 "Liver radiofrequency ablation treatment equipment". Compared with YY 0776-2010, except for structural adjustment and compilation In addition to editorial changes, the main technical changes are as follows. ---Changed the definitions of liver radiofrequency ablation treatment equipment and liver radiofrequency ablation electrodes (see 3.1, 3.2,.2010 version of 3.1, 3.2); ---Added terms and definitions for water-cooled liver radiofrequency ablation electrodes and auxiliary (remote) temperature probes (see 3.3, 3.4); ---Changed the requirements for operating frequency and rated output power (see 4.2, 4.3, 5.2.1, 5.2.2 of the.2010 edition); ---Added requirements for high current mode (see 4.4); ---Changed the requirements for temperature display function, impedance display function, protection function and timing function (see 4.5, 4.6, 4.7, 4.8,.2010 Versions 5.2.3, 5.2.5, 5.2.7, 5.2.6); ---Added requirements for perfusion pumps (see 4.9); ---Changed the requirements for foot switches (see 4.10, 5.5 of the.2010 version); ---Added requirements for size, DC resistance, insulation resistance, Luer connector, and corrosion resistance (see 4.11.1, 4.11.2, 4.11.3, 4.11.6); ---Changed the requirements for neutral electrode, environmental testing, safety, and electromagnetic compatibility (see 4.12, 4.13, 4.14, 4.15,.2010 edition 5.4, 5.8, 5.6, 5.7); ---Deleted biocompatibility, temperature control range and error, minimum area, and additional requirements for instructions for use (see the.2010 version of 5.3.1, 5.4.1, 5.2.4, 5.4.2, 5.9). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee of the National Medical Electrical Standardization Technical Committee (SAC/TC10/SC4). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Med Medical Technology (Shanghai) Co., Ltd. The main drafters of this document. Liu Bo, Yang Jiangang, Zhang Longfei, Li Yanan, Hou Feixiang, and Lu Suyang. The previous versions of the documents replaced by this document are as follows. ---First released in.2010 as YY 0776-2010; ---This is the first revision. Liver radiofrequency ablation treatment equipment

1 Scope

This document specifies the requirements and test methods for liver radiofrequency ablation therapy equipment (hereinafter referred to as "equipment") and its accessories. This document applies to liver radiofrequency ablation treatment equipment and its accessories.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) conical connectors Part 2.Locking connectors GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB 9706.202-2021 Medical electrical equipment Part 2-2.Basic safety and fundamentals of high-frequency surgical equipment and high-frequency accessories Special requirements can be GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 14710 Environmental requirements and test methods for medical electrical appliances YY/T 0149 Test method for corrosion resistance of stainless steel medical instruments YY 9706.102-2021 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance. Parallel standards. Electromagnetic compatibility requirements and tests YY 1057 General technical conditions for medical foot switches Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions as defined in GB 9706.1 and GB 9706.202-2021 apply to this document. 3.1 It is expected to be used in conjunction with liver radiofrequency ablation electrodes and other accessories to use high-frequency current to ablate liver solid tumors. technical equipment. 3.2 A surgical accessory used in conjunction with liver radiofrequency ablation treatment equipment. The electrode tip is usually passed through the skin under the guidance of imaging equipment such as ultrasound. The puncture operation reaches the liver target tissue, and the high-frequency current generated by the device is transmitted to the target tissue for ablation treatment. Note. Liver radiofrequency ablation electrodes can contain temperature sensors, such as thermocouples, thermistors, etc. 3.3 The liver radiofrequency ablation electrode is used in conjunction with the perfusion pump. Driven by the perfusion pump, the cooling liquid flows through the electrode, counter electrode and adjacent tissue. Cool down to prevent carbonization and increase the ablation area.

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