YY/T 1496-2016 English PDF

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YY/T 1496-2016: Red light therapy equipment
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1496-2016	239	Add to Cart	3 days	Red light therapy equipment	Valid

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Basic data

Standard ID: YY/T 1496-2016 (YY/T1496-2016)
Description (Translated English): Red light therapy equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C42
Word Count Estimation: 12,196
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Quoted Standard: GB/T 191-2008; GB 9706.1-2007; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY/T 0466.1-2009; YY 0505-2012
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and storage of red light therapy equipment. This standard applies to the red light treatment equipment defined in 3.1 (hereinafter referred to as the device). For a multifunctional device, the provisions of this standard apply only to the device's red light treatment function, the device's other functions should meet the requirements of the relevant standards.

YY/T 1496-2016: Red light 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.
Red light therapy equipment ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Red light treatment equipment 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Composition 2 5 request 2 6 Test Method 3 7 Inspection Rules 6 8 logo, label, instruction manual 6 9 Packaging, transportation, storage 8 Appendix A (informative) Evaluation of the spectral weighting function of UV hazards

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 issuer of this document does not assume responsibility for the identification of 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 of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Shenzhen Pu Men Technology Co., Ltd. The main drafters of this standard. Han desert, Zhang Yun, Qi Ruijing, Qian Xuebo, Duan Chuanying, Xu Yan. Red light treatment equipment

1 Scope

This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and Storage. This standard applies to the red light treatment equipment defined in 3.1 (hereinafter referred to as equipment). For a multi-functional device, this standard is in rule The contents of the device only apply to the device's red light treatment function, the device's other functions should meet the requirements of the relevant standards.

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/T 191-2008 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007 GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety Claim 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 Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic Claim YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests

3 terms and definitions

GB 9706.1-2007 and the following terms and definitions apply to this document. 3.1 It is expected that irradiation of the patient's body surface (excluding the natural cavity) with irradiation of incoherent light having a wavelength in the range of 600 nm to 760 nm device of. 3.2 Effective irradiated face effectiveexposurearea The manufacturer's prescribed treatment surface includes information on the area and shape of the treatment surface and the irradiation distance and irradiation angle associated with it. 3.3 Effective surface temperature sensor effectiveexposureareatemperaturesensor A signal sensing device comprising a connection portion with a device for monitoring the temperature of an effective irradiating surface. 3.4 Effective red light irradiance effectiveredlightirradiance; The irradiance of the irradiated surface is equivalent to the irradiance assessed in the range of 600 nm to 760 nm, ......

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