YY/T 0061-2021 English PDFUS$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0061-2021: Specified electromagnetic wave therapy equipment Status: Valid YY/T 0061: Historical versions
Basic dataStandard 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 ForewordThis 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 device1 ScopeThis 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 referencesThe 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 Tests3 Terms and definitions3.1 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 composition4.1 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0061-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 0061-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0061-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0061-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
