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YY 0897-2013Radiofrequency ablation equipment for ear, nose and throat (English PDF)

耳鼻喉射频消融设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

November 1, 2025

Implementation date

October 1, 2014

Scope

YY 0897-2013 is the English-translated version of 耳鼻喉射频消融设备.

YY 0897-2013 is the Chinese standard "Radiofrequency ablation equipment for ear, nose and throat". Its scope clause reads: This standard specifies the equipment Otolaryngology ablation terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation Transport and storage. Its clauses include terms and definitions.

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Document preview — YY 0897-2013

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C42

Issued by: National Medical Products Administration

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 consisting of
5 Requirement
6 Test Method
7 inspection rules
8 signs, instructions
9 packaging, transportation and storage

1 Scope

This standard specifies the equipment Otolaryngology ablation terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation

Transport and storage.

3.1

This standard applies to the definition of ENT radiofrequency ablation device (hereinafter referred to as the device).

This standard does not apply to high-frequency electrocautery device.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs

GB 7543 single-use sterile rubber surgical gloves

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.4-2009 Medical electrical equipment - Part 2-2. requirements for the safety of high frequency surgical equipment

GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis

GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods

GB/T 14710 medical electrical environmental requirements and test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests

GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test

Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General

Claim

YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests

YY 91057 medical foot switch General technical conditions

3 Terms and Definitions

GB 9706.1-2007 and GB 9706.4-2009 defined in the following terms and definitions apply to this document.

3.1

Including related accessories, including medical electrical equipment, it is expected to use ENT radiofrequency ablation electrode (hereinafter referred to as ablation electrode) the frequency of

200kHz ~ 5MHz of radio frequency energy to the site of submucosal ENT target tissues, its ablation.

3.2 ENT radiofrequency ablation electrode radio-frequencyablationelectrodeforear, noseandthroat

And equipment used in conjunction to achieve the surgical ablation of accessory is expected to pierce the mucosa ENT site passing shot down its target tissues

Frequency energy.

NOTE. ENT radiofrequency ablation electrode may be a monopolar electrode, or a bipolar electrode.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

Referenced standards

Normative references

GB 7543

Similar standards

YY 0899|YY 0950|YY 0903|YY/T 0860|YY/T 0323

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