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YY/T 0776-2023Liver radiofrequency ablation therapy equipment (English PDF)

肝脏射频消融治疗设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 20, 2023

Implementation date

July 1, 2025

Scope

YY/T 0776-2023 is the English-translated version of 肝脏射频消融治疗设备.

YY/T 0776-2023 is the Chinese standard "Liver radiofrequency ablation therapy equipment". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY/T 0776-2023

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C42
Replacing: YY/T 0776-2010

Issued by: National Medical Products Administration

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY 0899|YY 0778|YY 0903|YY 0777

Editions of YY/T 0776

Edition	Title	Revision	Status
YY/T 0776-2023	Liver radiofrequency ablation therapy equipment	current edition	Current
YY/T 0776-2010	Liver radiofrequency ablation therapy equipment	previous edition	In force until 2025-07-01

This page sells the current edition, YY/T 0776-2023. Earlier editions are listed for reference only.

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