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YY/T 0061-2021: Specified electromagnetic wave therapy equipment
Status: Valid YY/T 0061: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0061-2021 | English | 189 |
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3 days [Need to translate]
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Specified electromagnetic wave therapy equipment
| Valid |
YY/T 0061-2021
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| YY/T 0061-2007 | English | 399 |
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3 days [Need to translate]
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Specified electromagnetic wave therapy equipment
| Obsolete |
YY/T 0061-2007
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| YY 0061-1991 | English | 319 |
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3 days [Need to translate]
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(Specific electromagnetic treatment)
| Obsolete |
YY 0061-1991
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PDF similar to YY/T 0061-2021
Standard similar to YY/T 0061-2021 YY 0778 YY 0950 YY 0903 YY/T 0323 YY 0060 Basic data | Standard ID | YY/T 0061-2021 (YY/T0061-2021) | | Description (Translated English) | Specified electromagnetic wave therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Word Count Estimation | 10,155 | | Issuing agency(ies) | State Drug Administration | YY/T 0061-2021: Specified electromagnetic wave 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.
Specified electromagnetic wave therapy equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0061-2007
Specific electromagnetic wave therapy device
Released on 2021-03-09
2023-05-01 implementation
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0061-2007 "Specific Electromagnetic Wave Therapy Device", compared with YY/T 0061-2007, except for editorial changes
The main changes are as follows.
---Modified the definition of thermal response time, and changed the thermal response time to heating time (see 3.2, 3.3 in.2007 edition);
---Deleted the definition of specific electromagnetic wave therapy device (2007 edition 3.2);
--- Increased the structure and composition of the radiator (see 4.3);
---Relevant requirements for temperature unevenness have been revised (see 5.3.2, 5.3.2 of the.2007 edition);
---Modified the maximum allowable temperature limit (see 5.3.3, 5.3.3 of the.2007 edition);
---Relevant requirements for heating time (original thermal response time) have been modified (see 5.4.1, 5.4.1 of the.2007 edition);
---Relevant requirements and test methods for overheating protection have been modified (see 5.5, 6.5, 5.5 and 6.5 in.2007 edition);
---Increased flame resistance requirements (see 5.7);
--- Increased dielectric strength requirements at operating temperature (see 5.11);
--- Deleted the heater's working life requirement (2007 version 5.6);
---Delete the parts that overlap with the requirements of YY 0306 (5.8, 5.9, 5.10.3 of the.2007 edition).
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) of the National Medical Electrical Appliance Standardization Technical Committee.
Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Chongqing Medical Device Quality Inspection Center.
The main drafters of this standard. Yang Guojuan, Qian Xuebo, Liu Bo, Zhou Ping, Jiang Yongyu, Wang Zhifang.
The previous versions of the standard replaced by this standard are as follows.
---YY 0061-1991, YY/T 0061-2007.
Specific electromagnetic wave therapy device
1 Scope
This standard specifies the structure and composition, requirements and test methods of a specific electromagnetic wave therapy device (hereinafter referred to as the therapy device).
This standard is applicable to conform to the elements contained in the radiator that are excited by heat at a certain temperature, and the energy produced is mainly distributed in 2μm~
A therapeutic device for electromagnetic waves in the 25μm wavelength range.
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/T 5169.16 Fire hazard test for electric and electronic products Part 16.Test flame 50W horizontal and vertical flame test
method
GB/T 7287-2008 Infrared radiant heater test method
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB 18871 Basic standard for ionizing radiation protection and radiation source safety
YY 0306 Special requirements for the safety of thermal radiation therapy equipment
YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
3 Terms and definitions
3.1
Specified electromagnetic wave
The elements contained in the radiator are excited by heat at a certain temperature, and the energy produced is mainly distributed in the wavelength range of 2μm~25μm.
Magnetic wave.
3.2
Temperature rise time temperaturerisetime
The time required for the surface temperature of the radiator to rise from room temperature to 90% of the nominal temperature.
4 Structure and composition
4.1 Treatment head. It should include heating elements, radiators and protective covers.
4.2 Heating element. a conductive heating material that converts electrical energy into heat energy to provide heat for the radiator.
4.3 Radiator. It has a specific element composition or coating, and is expected to absorb heat and radiate electromagnetic waves to the patient.
Parts in direct contact with the body.
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