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YY 0306-2023: General technical requirements for heat radiation therapy equipment
Status: Valid YY 0306: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0306-2023 | English | 179 |
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3 days [Need to translate]
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General technical requirements for heat radiation therapy equipment
| Valid |
YY 0306-2023
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| YY 0306-2018 | English | 159 |
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Particular requirements for the safety of heat radiation therapy equipment
| Valid |
YY 0306-2018
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| YY 0306-2008 | English | 319 |
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Particular requirements for the safety of heat radiation therapy equipment
| Obsolete |
YY 0306-2008
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| YY 0306-1998 | English | 359 |
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3 days [Need to translate]
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Particular requirements for the safety of heat radiation therapy equipment
| Obsolete |
YY 0306-1998
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PDF similar to YY 0306-2023
Basic data | Standard ID | YY 0306-2023 (YY0306-2023) | | Description (Translated English) | General technical requirements for heat radiation therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 9,961 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2026-09-15 | | Older Standard (superseded by this standard) | YY 0306-2018 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements and test methods for thermal radiation therapy equipment. This standard applies to thermal radiation treatment equipment. This document does not apply to the following equipment: equipment whose thermal radiation energy cannot directly reach the patient's body surface, such as being blocked by non-hollow structures or non-transparent materials during the propagation process; treating patients by heat conduction as defined in YY/T 0165 Equipment expected to cause tissue degeneration and/or coagulative necrosis as defined in YY 0323; Contact far infrared physiotherapy equipment as defined in YY/T 0902. | YY 0306-2023: General technical requirements for heat radiation therapy 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 Standards of the People's Republic of China
Replaces YY 0306-2018
General technical requirements for thermal radiation treatment equipment
Published on 2023-09-05
Implemented on 2026-09-15
Released by the State Drug Administration
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY 0306-2018 "Special Safety Requirements for Thermal Radiation Treatment Equipment". Compared with YY 0306-2018, except for the structure
In addition to adjustments and editorial changes, the main technical changes are as follows.
---Changed the description of the scope (see Chapter 1, Chapter 1 of the.2018 edition);
---Changed the definitions of thermal radiation, radiators, and thermal radiation treatment equipment (see 3.1, 3.2, 3.3, 2.1.101 of the.2018 edition,
2.1.102, 2.1.103);
---Deleted the term and definition thermal protection (see 2.1.104 of the.2018 edition);
---Added terms and definitions of emissivity (see 3.4);
---Deleted the classification (see Chapter 5 of the.2018 edition);
--- Added requirements and test methods for radiation characteristics (see 4.1, 5.1);
---Changed the requirements and test methods of the general provisions (see 4.3.1, 5.3.1, 34 of the.2018 edition);
---Deleted some requirements and test methods for changes to the general standard clauses (14.6, 24.103, 42.3,.2018 version)
42.5, 44.7, 51.101).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee of the National Medical Electrical Standardization Technical Committee (SAC/TC10/SC4).
The previous versions of the standard replaced by this document are as follows.
---First released as YY 0306-1998 in.1998, revised for the first time in.2008, and revised for the second time in.2018;
---This is the third revision.
General technical requirements for thermal radiation treatment equipment
1 Scope
This document specifies the requirements and test methods for thermal radiation therapy equipment (hereinafter referred to as "equipment").
This document applies to thermal radiation treatment equipment.
This document does not apply to the following equipment.
--- Devices whose thermal radiation energy cannot directly reach the patient's body surface, such as being blocked by non-hollow structures or non-transparent materials during the propagation process;
---Equipment for treating patients by heat conduction as defined in YY/T 0165;
---Devices expected to cause tissue degeneration and/or coagulative necrosis as defined in YY 0323;
---Contact far-infrared physiotherapy equipment defined in YY/T 0902.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 7287-2008 Infrared radiation heater test method
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB 9706.283 Medical electrical equipment Part 2-83.Special requirements for basic safety and basic performance of household phototherapy equipment
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards. Electromagnetic and
Capacity requirements and testing
YY 9706.111 Medical electrical equipment Part 1-11.General requirements for basic safety and basic performance Collateral standards. in the home
Requirements for medical electrical equipment and medical electrical systems used in care environments
YY 9706.257 Medical electrical equipment Part 2-57.Non-laser light sources for treatment, diagnosis, monitoring and plastic surgery/medical cosmetology
Specific requirements for basic safety and basic performance of equipment
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
heat radiationheatradiation
The process of transferring energy in the form of electromagnetic waves resulting from thermal motion.
3.2
radiatorradiator
Components that have strong thermal radiation capabilities and are not in direct contact with the human body during use can effectively convert the heat energy they absorb into thermal radiation.
Radiated energy (electromagnetic waves).
Note 1.If the radiator is in direct contact with the patient, the main way of energy exchange between the radiator and the patient is heat conduction rather than heat radiation, for example, if it has an infrared coating
Materials for heating pad and foot stove. Other parts other than the radiator (such as protective covers other than the radiator) may be in contact with the human body or in use according to design requirements.
not in contact.
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