General technical requirements for radio frequency ablation equipment
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
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
General technical requirements for radio frequency ablation equipment
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
Contents of YY 0650-2022
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
