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YY/T 0982-2016: Heating and magnetic vibrater therapeutic equipment
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0982-2016 | English | 139 |
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Heating and magnetic vibrater therapeutic equipment
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YY/T 0982-2016
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Basic data | Standard ID | YY/T 0982-2016 (YY/T0982-2016) | | Description (Translated English) | Heating and magnetic vibrater therapeutic equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 7,730 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0982-2016: Heating and magnetic vibrater therapeutic 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.
Heating and magnetic vibrater treatment equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Thermal magnetizer treatment equipment
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized.
The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration
Bureau of Guangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Qi Lijing, Wu Yiming, Zhang Yun, Lu Wenjuan, Liu Bo, Qian Xuebo.
Thermal magnetizer treatment equipment
1 Scope
This standard specifies the terms and definitions, requirements, and test methods for thermomagnetic transducer treatment equipment (hereinafter referred to as equipment).
This standard applies to the equipment defined in 3.1.
This standard does not apply to thermal pad therapeutic apparatus.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
Environmental requirements and test methods for medical appliances GB/T 14710-2009
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
(ISO 10993-1..2009, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2..2004, IDT)
3 terms and definitions
GB 9706.1-2007 and the following terms and definitions apply to this document.
3.1
Heat magnetizer treatment equipment heatingandmagneticvibratortherapeuticequipment
A medical electrical device in which the application part comprises a thermomagnetic transducer, which utilizes the magnetic field generated by the thermomagnetic transducer, vibrates and conducts heat to the patient
For treatment.
3.2
Thermal magnetator heatingandmagneticvibrator
Components made of winding coils and ferromagnetic materials. When there is a pulse or alternating current through, the part will heat up and produce both magnetic
Field and vibration.
3.3
Steady state temperature
After the equipment has been in operation for some time, the temperature of the application part starts to fluctuate within ± 0.5 ° C of a certain temperature value, which is steady-state
temperature.
4 requirements
4.1 normal working conditions
Shall comply with the manufacturer's regulations; if not specified, it shall comply with the requirements of Chapter 10 of GB 9706.1-2007.
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