YY 0650-2022General technical requirements for radio frequency ablation equipment (English PDF)
射频消融治疗设备通用技术要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2022
Implementation date
November 1, 2025
Scope
YY 0650-2022 is the English-translated version of 射频消融治疗设备通用技术要求.
YY 0650-2022 is the Chinese standard "General technical requirements for radio frequency ablation equipment". Its scope clause reads: This document specifies the terms and definitions, requirements and test methods of radio frequency ablation equipment (hereinafter referred to as the "equipment").
This document is applicable to radio frequency ablation equipment and its accessories. This document is not applicable to the radio frequency therapy equipment for atraumatic superficial treatment. Its clauses include terms and definitions; requirements.
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Document preview — YY 0650-2022
National Standard of the People's Republic of China
- Replacing
- YY 0650-2008
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements
- 5 Test methods
1 Scope
This document specifies the terms and definitions, requirements and test methods of radio frequency ablation equipment (hereinafter referred to as the "equipment").
This document is applicable to radio frequency ablation equipment and its accessories.
This document is not applicable to the radio frequency therapy equipment for atraumatic superficial treatment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
YY 0778 Radio frequency ablation catheter
YY 1057 General specifications for medical foot switch
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1 and GB 9706.202 and the following apply.
3.1 radio frequency ablation equipment
surgical equipment intended to be used in conjunction with radio frequency ablation accessories to perform ablation therapy using the thermal effects of high frequency current on human tissue
3.2 temperature controlled mode
a control mode that regulates the radio frequency output power through a temperature feedback mechanism so that the target tissue reaches a preset target temperature and then fluctuates around the target temperature
3.3 radio frequency ablation accessory
accessory intended to transmit, supplement, or monitor the radio frequency energy applied to the patient from the radio frequency ablation equipment
4 Requirements
4.1 Working conditions
The manufacturer shall specify at least the following normal working condition parameters in the accompanying documents:
——Ambient temperature;
——Relative humidity;
——Power supply.
4.2 Output waveform parameters
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY 0650
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0650-2022 | General technical requirements for radio frequency ablation equipment | current edition | Current |
| YY 0650-2008 | General technical requirements for radio frequency ablation equipment | previous edition | Superseded |
This page sells the current edition, YY 0650-2022. Earlier editions are listed for reference only.
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