YY 0838-2021 English PDF

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YY 0838-2021: Microwave ablation/coagulation equipment
Status: Valid

YY 0838: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0838-2021	169	Add to Cart	3 days	Microwave ablation/coagulation equipment	Valid
YY 0838-2011	639	Add to Cart	4 days	Microwave ablation/coagulation equipment	Obsolete

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YY 0778   YY 0950   YY 0903   YY/T 0833   YY 0839   

Basic data

Standard ID: YY 0838-2021 (YY0838-2021)
Description (Translated English): Microwave ablation/coagulation equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Word Count Estimation: 9,947
Issuing agency(ies): State Drug Administration

YY 0838-2021: Microwave ablation/coagulation equipment

---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.
Microwave ablation/coagulation equipment ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standards Replace YY 0838-2011 Microwave thermocoagulation equipment Released on 2021-03-09 2023-05-01 implementation Issued by the National Medical Products Administration

Foreword

All technical content of this standard is mandatory. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0838-2011 "Microwave Thermocoagulation Equipment". Compared with YY 0838-2011, the main technology except for editorial changes The changes are as follows. ---Modified the definitions of the terms microwave thermocoagulation equipment and fuser (see 3.1, 3.2, 3.1, 3.3 of the.2011 edition); ---Added the definitions of the terms superficial tissue thermocoagulation equipment, internal tissue thermocoagulation equipment, and prostate thermocoagulation equipment (see 3.3~3.5); --- Added the definition of superficial tissue thermocoagulator (see 3.6); ---Modified the content of composition and classification (see Chapter 4, Chapter 4 of the.2011 edition); ---Modified the requirements and test methods for working frequency, output power, timing, power adjustment (see 5.2~5.5, 6.2~6.5,.2011 Version 5.2~5.5, 6.2~6.5); ---Added no-load protection requirements and test methods (see 5.6, 6.6); ---Modified the requirements and test methods for the surface temperature of the fuser (see 5.7, 6.7, 5.9, 6.9 in the.2011 edition); ---Added cooling system requirements and test methods (see 5.8, 6.8); ---The requirements and test methods for tissue temperature measurement, tissue temperature control, and over-temperature protection have been revised (see 5.9~5.11, 6.9~6.11,.2011 edition 5.6~5.8, 6.6~6.8); ---Added the adaptation function, multi-source output power requirements and test methods (5.12, 5.13, 6.12, 6.13); ---Modified the requirements and test methods of the instruction manual (see 5.14, 6.14, 5.12.5, 6.12 of the.2011 edition); ---Added requirements and test methods for undesired radiation (5.15, 6.15); ---Modified the foot switch, safety requirements and test methods (see 5.17, 5.18, 6.17, 6.18, 5.11, 5.12 of the.2011 edition 6.11, 6.12); ---Deleted the definitions of terms applied part, rated output power, unwanted radiation, and matched load (2011 version 3.2, 3.4~3.6); ---Deleted inspection rules, signs, packaging, transportation, and storage (Chapters 7, 8, and 9 of the.2011 edition); --- Deleted Appendix A (Appendix A of the.2011 edition). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) of the National Medical Electrical Appliance Standardization Technical Committee. Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Nanjing Kangyou Medical Technology Co., Ltd., Kehui (China) Medical Medical Equipment Technology Co., Ltd., Tianjin Shunbo Medical Equipment Co., Ltd. The main drafters of this standard. Duan Qiaofeng, Ye Mingyang, Liu Hui, Jia Ruoxian, Tang Shujun, Li Minghua. The previous versions of the standard replaced by this standard are as follows. ---YY 0838-2011. Microwave thermocoagulation equipment

1 Scope

This standard specifies the composition, classification, requirements, and test methods of microwave thermocoagulation equipment (hereinafter referred to as equipment). This standard applies to the use of contact applicators to transmit electromagnetic fields with a frequency greater than 300MHz but not more than 30GHz in the organization, so that This standard is also applicable to microwave thermocoagulation equipment used in medical practice where local tissues of patients are coagulated/ablated. Combination equipment.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB 9706.206 Medical electrical equipment Part 2-6.Specific requirements for the basic safety and basic performance of microwave therapy equipment GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests YY 0899 General requirements for accessories of medical microwave equipment YY 1057 General technical conditions for medical foot switches

3 Terms and definitions

The following terms and definitions defined in GB 9706.1, GB 9706.206 and YY 0899 apply to this document. 3.1 Use a contact applicator to transmit an electromagnetic field with a frequency greater than 300MHz but not more than 30GHz in the tissue, so that the patient's local tissue Microwave treatment equipment that produces coagulation/ablation. 3.2 Ablation/coagulationapplicator A contact applicator that transmits microwave energy in local tissues and coagulates/ablates the tissues. 3.3 Superficialorganizationablation/coagulationequipment Microwave thermocoagulation equipment used for superficial skin or open cavity can be directly visualized to coagulate hyperplasia and diseased tissues. 3.4 In vivo tissue thermocoagulation equipment intracorporalorganizationablation/coagulationequipment Under the guidance of auxiliary equipment such as imaging, microwave heat is used for coagulation/ablation treatment of intracorporeal or non-visual cavity hyperplasia and diseased tissues. Coagulation equipment. 3.5 Prostateablation/coagulation equipment A microwave thermal coagulation device for coagulation/ablation of benign prostatic hyperplasia tissue by using a prostate thermal coagulator. ......

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