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YY 0901-2013: Ultraviolet therapy equipment
Status: Obsolete
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| YY 0901-2013 | English | 439 |
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Ultraviolet therapy equipment
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YY 0901-2013
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Basic data | Standard ID | YY 0901-2013 (YY0901-2013) | | Description (Translated English) | Ultraviolet therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 11,151 | | Quoted Standard | GB/T 191; GB 9706.1-2007; GB/T 14710; GB/T 16886.1; YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions of UV treatment equipment, classification, requirements, test methods, inspection rules, signs and instructions, packaging, transport and storage. UV therapy equipment used (hereinafter referred to as the | YY 0901-2013: Ultraviolet 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.
Ultraviolet therapy equipment
ICS 11.040.60
C42
People's Republic of China pharmaceutical industry standards
UV therapy equipment
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the regulation
Set the standard GB 9706.1-2007 the relevant provisions were amended and supplemented.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
If the requested material or structure in the form of equipment or components used in connection with the standards required by different, but if they can prove that it reaches the same
Requirements, which should be recognized.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Han desert, Zhang Yun, Liu Bo, Duan Qiao Feng.
UV therapy equipment
1 Scope
This standard specifies the terms and definitions of UV treatment equipment, classification, requirements, test methods, inspection rules, signs and manual, package
Loading, transport and storage.
UV treatment device for use (hereinafter referred to as the device) of the requirements of this standard applies 3.1 defined in medical practice.
This standard does not apply to the following devices.
--- Instruments and materials for irradiating ultraviolet disinfection or sterilization equipment only;
--- Curing light;
--- Ultraviolet laser equipment;
--- UV-sensitive treatment equipment;
--- Ultraviolet blood irradiation apparatus.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710 medical electrical environmental requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
GB 9706.1-2007 defined and the following terms and definitions apply to this document.
3.1
Use effective wavelength at 200nm ~ 400nm ultraviolet radiation on the human body radiation therapy equipment.
Note. In general, ultraviolet light is divided into three bands. UVA (400nm ~ 320nm), UVB (320nm ~ 275nm), UVC (275nm ~
200nm).
3.2
Effective irradiated area enablediluminatedarea
Area for irradiation treatment specified by the manufacturer, usually including the irradiated area, distance, angle, shape and other information.
3.3
UV radiation dose ultravioletirradiationdose
UV radiation energy by unit area on the photograph, which is equal to the product of the intensity of UV radiation and irradiation time, in units of J/cm2.
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