YY/T 0932-2014 English PDF (YYT0932-2014)

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YY/T 0932-2014: Medical luminaries. Medical head-mounted luminaires
YY/T 0932-2014
Medical luminaries. Medical head-mounted luminaires
ICS 11.040
C40
People's Republic of China pharmaceutical industry standards
Medical lighting Medical lighting amount worn
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted. Zhejiang Medical Device Testing Institute, the State Food and Drug Administration Medical Device Quality Supervision, Inspection and Hangzhou
center.
The main drafters of this standard. Wang Jingtao, JIA Xiao Hang, He Tao, Qi Weiming.
Medical lighting Medical lighting amount worn
1 Scope
This standard specifies the requirements and test methods for medical-worn volume lights. Medical Lighting amount worn Dr. Dai Zai head for the clinical
Patient diagnostic check lighting.
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 5702-2003 light color evaluation method
GB/T 7922-2008 lighting color measurement method
GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety
GB/T 14710-2009 medical electrical environmental requirements and test methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
Light biosafety GB/T 20145-2006 lamps and lamp systems
JB/T 7403-1994 light meter
ISO 15004-2.2007 ophthalmic instruments basic requirements and test methods - Part 2. Light hazard protection (Ophthalmicinstru-
ments-Fundamentalrequirementsandtestmethods-Part 2. Lighthazardprotection)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Medical Lighting amount worn medicalhead-mountedluminaries
Dr. Dai Zai head means for illuminating the patient diagnostic tests.
4 Requirements
4.1 Optical Requirements
4.1.1 Illumination
The manufacturer shall specify the illumination from the light outlet at a distance specified, tolerance is ± 20%.
4.1.2 spot diameter
The manufacturer shall specify the light exit from the designated spot diameter at a distance, tolerance of ± 10%.