YY 0650-2022 English PDF

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YY 0650-2022: General technical requirements for radio frequency ablation equipment
Status: Valid

YY 0650: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0650-2022	219	Add to Cart	3 days	General technical requirements for radio frequency ablation equipment	Valid
YY 0650-2008	389	Add to Cart	3 days	Gynecological radio frequency therapy instrument

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Basic data

Standard ID: YY 0650-2022 (YY0650-2022)
Description (Translated English): General technical requirements for radio frequency ablation equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Word Count Estimation: 10,171
Date of Issue: 2022-10-17
Date of Implementation: 2025-11-01
Older Standard (superseded by this standard): YY 0650-2008; YY 0897-2013
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the terms and definitions, requirements and test methods of radiofrequency ablation therapy equipment. This standard applies to radiofrequency ablation therapy equipment and its accessories. This standard does not apply to radio frequency treatment equipment for non-invasive superficial treatment.

YY 0650-2008: Gynecological radio frequency therapy instrument

---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.
Gynecological radio frequency therapy instrument ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Gynecological radiofrequency treatment instrument Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued

Foreword

Gynecological surgery is the use of radio frequency treatment instrument electrodes directly to the target tissue to deliver RF energy to reach the target tissue cutting, coagulation, denaturation Necrosis and a radiofrequency treatment of gynecological instruments. In order to standardize the technical characteristics of the product, to ensure the safety and effectiveness of the product, specially formulated Bank Industry standards, as a basis for production and quality control. The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and GB 9706.4 "Medical electrical equipment - Part 2. requirements for the safety of high frequency surgical equipment" requirement. The standards for electromagnetic compatibility to Seeking fully implement the YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility To Sum test "requirement. Appendix A of this standard is the data appendix. This standard was proposed by the State Food and Drug Administration. Drafting of this standard. National Food and Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center, Wuhan Medical HTS Technology Development Co., MedSphere (Shanghai) Co., Ltd. This standard by the National Standardization Technical Committee on Medical Electrical Standardization Technical Committee of physical therapy equipment. The main drafters of this standard. Alpine, Qiuxue Hua, Ye Zhenyu, Zhang Xuehao, PROCEEDINGS, Duan Qiao Feng. Gynecological radiofrequency treatment instrument

1 Scope

This standard specifies the definition of gynecological radiofrequency treatment instrument, classification, requirements, test methods, inspection rules, marking, packaging, transport and storage. 3.1 This standard applies to the definition of gynecological radiofrequency treatment instrument (hereinafter referred to as treatment instrument), the instrument used in surgery gynecological-related diseases treatment.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 191 Packaging - Pictorial signs GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.4 Medical electrical equipment - Part 2. requirements for the safety of high frequency surgical equipment (GB 9706.4-1999, idt IEC 60601-2-2.1999) GB 9706.15-1999 Medical electrical equipment - Part 1. General requirements for safety 1. Collateral standard. medical electrical systems security Requirements (idt IEC 60601-1-1.1995) GB/T 14233.1-1998 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB/T 14710 Medical electrical equipment environmental requirements and test methods GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997) GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Tests for cytotoxicity. in vitro methods (ISO 10993-5. 1997, IDT) GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993- 10.2002, IDT) GB/T 19633-2005 Packaging for terminally sterilized medical devices (ISO 11607.2003, IDT) YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.2001, IDT) YY 91057 medical foot switch General technical conditions

3 Terms and Definitions

GB 9706.4 and established in the following terms and definitions apply to this standard. 3.1 Use of surgical electrodes directly 100kHz ~ 5MHz (500kHz ± 5kHz not be used as a therapeutic device operating frequency) radio transmitting To the target tissue, in order to achieve the target tissue cutting, coagulation, degeneration and gynecological radiofrequency ablation instrument necrosis.

4 Classification and composition

4.1 Classification Treatment instrument according to the control mode is divided into temperature control and temperature/load impedance control. ......

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