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YY 0777-2023: (Radio frequency hyperthermia equipment)
Status: Valid YY 0777: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0777-2023 | English | 169 |
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(Radio frequency hyperthermia equipment)
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YY 0777-2023
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| YY 0777-2010 | English | 349 |
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Radio frequency hyperthermia equipment
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YY 0777-2010
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PDF similar to YY 0777-2023
Standard similar to YY 0777-2023 YY 0778 YY 0950 YY 0903 YY/T 0776 Basic data | Standard ID | YY 0777-2023 (YY0777-2023) | | Description (Translated English) | (Radio frequency hyperthermia equipment) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 8,894 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2026-01-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements and test methods for radio frequency hyperthermia equipment. This standard applies to radio frequency hyperthermia equipment. This standard does not apply to radiofrequency ablation equipment. | YY 0777-2023: (Radio frequency hyperthermia 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.
ICS 11.040.60
CCSC42
Pharmaceutical Industry Standard of the People's Republic of China
Replace YY 0777-2010
Radio frequency hyperthermia equipment
Released on 2023-01-13
2026-01-15 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document replaces YY 0777-2010 "Radio Frequency Hyperthermia Equipment". Compared with YY 0777-2010, except for structural adjustment and editorial changes
In addition, the main technical changes are as follows.
--- Deleted the content of the composition (see Chapter 4 of the.2010 edition);
--- Changed the output power requirements and test methods (see 4.2, 5.3, 5.3, 6.3 of the.2010 edition);
--- Changed the temperature measurement requirements and test methods (see 4.3, 5.4, 5.4, 6.4 of the.2010 edition);
--- Changed the temperature control requirements and test methods (see 4.4, 5.5, 5.5, 6.5 of the.2010 edition);
--- Changed the functional requirements and test methods (see 4.5, 5.6, 5.6, 6.6 of the.2010 edition);
--- Removed the appearance requirements and test methods (see 5.7, 6.7 of the.2010 edition);
--- Changed the safety requirements and test methods (see 4.7, 5.8, 5.8, 6.8 of the.2010 edition);
--- Changed the environmental test requirements and test methods (see 4.8, 5.9, 5.9, 6.9 of the.2010 edition);
---Changed the test conditions and the requirements of the required instrument tooling (see 5.1, 6.1 of the.2010 edition);
---Deleted inspection rules, signs, instructions for use, packaging, transportation, storage requirements (see Chapter 7~9 of the.2010 edition
chapter).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee.
The previous versions of the documents replaced by this document are as follows.
---YY 0777-2010.
Radio frequency hyperthermia equipment
1 Scope
This document specifies the requirements and test methods for radio frequency hyperthermia equipment (hereinafter referred to as equipment).
This document applies to radio frequency hyperthermia equipment.
This document does not apply to radiofrequency ablation devices.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; 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 Essential Performance
GB 9706.203-2020 Medical Electrical Equipment Part 2-3.Particular Requirements for Basic Safety and Essential Performance of Shortwave Therapy Equipment
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
3 Terms and Definitions
The following terms and definitions defined in GB 9706.1 and GB 9706.203-2020 apply to this document.
3.1
The electromagnetic field with a frequency of 3MHz~120MHz is used to act on the human body in the form of external radiation to heat the treatment area to achieve
Devices for tumor treatment or adjuvant therapy.
3.2
Automatic temperature control mode temp-autocontrolmode
The equipment can automatically adjust the radio frequency output to stabilize the temperature of the corresponding parts of the patient within a certain range above and below the temperature control target temperature
model.
4 requirements
4.1 Operating frequency
The operating frequency of the equipment shall not exceed ±2% of the nominal value.
4.2 Output power
4.2.1 The device should be able to display the RF output power in watts (W), and the output power can be adjusted.
4.2.2 The rated output power should not be less than 500W, and the output power error should not be greater than ±20%.
4.3 Temperature measurement
4.3.1 The equipment should be able to measure and display the temperature of at least 5 different parts at the same time.
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