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YY 0838-2021Microwave ablation and coagulation equipment (English PDF)

微波热凝设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 9, 2021

Implementation date

May 1, 2023

Scope

YY 0838-2021 is the English-translated version of 微波热凝设备.

YY 0838-2021 is the Chinese standard "Microwave ablation and coagulation equipment". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY 0838-2021

National Standard of the People's Republic of China

Classification: C42

Issued by: National Medical Products Administration

Foreword
5.6~5.8, 6.6~6.8);
6.11, 6.12);

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

YY 0899-2020General requirements for accessories of microwave equipment in medical use

Similar standards

YY 0899|YY 0778|YY 0903|YY/T 0833|YY 0839

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