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YY 0306-2023General technical requirements for heat radiation therapy equipment (English PDF)

热辐射类治疗设备通用技术要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

September 5, 2023

Implementation date

September 15, 2026

Scope

YY 0306-2023 is the English-translated version of 热辐射类治疗设备通用技术要求.

YY 0306-2023 is the Chinese standard "General technical requirements for heat radiation therapy equipment". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY 0306-2023

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C42
Replacing: YY 0306-2018

Issued by: National Medical Products Administration

Foreword
2.1.102, 2.1.103);
42.5, 44.7, 51.101).

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.

......
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/T 0061-2021Specified electromagnetic wave therapy equipment

Similar standards

YY 0899|YY 0778|YY 0903|YY/T 0860|YY/T 0323

Editions of YY 0306

Edition	Title	Revision	Status
YY 0306-2023	General technical requirements for heat radiation therapy equipment	current edition	Current
YY 0306-2018	General technical requirements for heat radiation therapy equipment	previous edition	In force until 2026-09-15

This page sells the current edition, YY 0306-2023. Earlier editions are listed for reference only.

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