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YY/T 1534-2017: Measuring methods for optical radiation safety classification of medical LED equipment
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1534-2017 | English | 179 |
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Measuring methods for optical radiation safety classification of medical LED equipment
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YY/T 1534-2017
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Basic data | Standard ID | YY/T 1534-2017 (YY/T1534-2017) | | Description (Translated English) | Measuring methods for optical radiation safety classification of medical LED equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 9,916 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1534-2017: Measuring methods for optical radiation safety classification of medical LED 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.
Measuring methods for optical radiation safety classification of medical LED equipment
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical LED equipment light radiation safety classification
Detection method
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Optical and Instrument Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard drafting unit. China Food and Drug Control Research Institute, Zhejiang Tiansong Medical Devices Co., Ltd., Suzhou Chinese Academy of Sciences students
Institute of Medical Engineering, Institute of Electronics, Chinese Academy of Sciences.
The main drafters of this standard. Liu Yan Zhen, Meng Xiangfeng, Li Ning, Liu Ping, Xiong Daxi, Fang Zhen, Ren Haiping.
Medical LED equipment light radiation safety classification
Detection method
1 Scope
This standard specifies the wavelength range of.200nm ~ 3000nm, with one or more light sources of medical LED equipment, optical radiation safety
Full classification of detection methods.
This standard does not apply to ophthalmic apparatus and infant phototherapy equipment.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 7247.1-2012 Safety of laser products - Part 1 Classification of equipment, requirements (IEC 60825-1.2007, IDT)
Photobiological safety of lamps and lamp systems
IEC 60601-2-57.2011 Medical electrical equipment - Part 2-57 - Non-lasers for treatment, diagnosis, monitoring and cosmetology/aesthetics
Basic requirements for safety and basic performance of light source equipment (Particularrequirementsforthebasicsafetyandessential
performanceofnon-laserlightsourcequipmentintendedfortherapeutic, diagnostic, monitoringand
cosmetic/aestheticuse)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Angle of reception angle;
The detector responds to the light radiation plane angle.
Note 1. The acceptance angle can be controlled by using aperture or optics.
Note 2. The unit is radian (rad).
Note 3. Rewrite IEC 60601-2-57.2011, Definition 2.1.101.
3.2
Aperture aperture aperturestop
The aperture used to determine the area through which radiation is to be measured.
[GB 7247.1.2012, Definition 3.9]
3.3
Antenna angularsubtense; α
The viewing angle of the observer's eye or measuring point by the light source or by the apparent light source.
Note 1. In this standard, the angle of intersection refers to the whole angle, not the half angle.
Note 2. The unit is radian (rad).
Note 3. Rewrite IEC 60601-2-57.2011, Definition 2.1.102.
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