YY/T 1401-2016 English PDF

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YY/T 1401-2016: Dental whitening accelerator
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1401-2016	219	Add to Cart	3 days	Dental whitening accelerator	Valid

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Basic data

Standard ID: YY/T 1401-2016 (YY/T1401-2016)
Description (Translated English): Dental whitening accelerator
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.20
Word Count Estimation: 11,143
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Quoted Standard: GB 9706.1-2007; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; GB/T 20145-2006
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements and test methods for dental whitening luminescence. This standard applies to the teeth whitening cold light instrument (hereinafter referred to as "cold light instrument", as defined in 3.1). In the dental clinical, cold light meter to cover the surface of the whitening agent to provide light source, so that whitening agent in the light under the chemical reaction. This standard applies to the use of halogen bulbs and/or LED lights as a light source of the cold instrument. This standard does not apply to the use of laser as a light source of the cold instrument.

YY/T 1401-2016: Dental whitening accelerator

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Dental whitening accelerator ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Teeth whitening cold light instrument 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Category 1 5 request 1 6 Test Method 3 7 Information provided by the manufacturer 6

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 Dental Materials and Equipment Standardization Technical Committee of Dental Equipment and Instruments Subcommittee (SAC/TC99 SC1). The drafting of the standard units. Nanchang Pu Yang Technology Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality supervision and inspection Xin, School of Physics Science and Engineering, Sun Yat - sen University. The main drafters of this standard. Li Danrong, Lu Wenjuan, Tang Jianfei, Wang Yirong, Jiang Shaoji.

Introduction

For the tooth whitening cold light meter in the 400nm to 650nm wavelength range of light radiation value, this standard did not make the request, but the application of this standard The prospective manufacturers should specify the radiation values in this wavelength range in their information vehicles. This standard provides a tooth whitening cold light instrument designed to dental clinics, to cover the surface of the whitening agent to provide light source irradiation, so that whitening The chemical reaction takes place under light irradiation. The relevant standards for whitening agents are described in YY/T 0825-2011 and YY/T 0632-2008. Teeth whitening cold light instrument

1 Scope

This standard specifies the requirements and test methods for dental whitening cold light. This standard applies to the teeth whitening cold light instrument (hereinafter referred to as "cold light instrument", as defined in 3.1). In dental clinics, the cold light meter is covered The whitening agent on the surface of the tooth provides a light source to cause the whitening agent to undergo a chemical catalytic reaction under light irradiation. This standard applies to the use of halogen bulbs and/or LED lights as a light source of the cold instrument. This standard does not apply to the use of laser as a light source of the cold instrument.

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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)] Light safety of light and light systems (CIES009/E..2002, IDT) GB/T.20145-2006

3 terms and definitions

GB/T 9937 (all parts) as defined and the following terms and definitions apply to this document. 3.1 Teeth whitening cold light whiteningaccelerator A permanent medical device that produces cold light in a specific wavelength range, which emits a whitening agent applied to the tooth surface, Chemical reaction occurs under irradiation.

4 classification

GB 9706.1-2007 in Chapter 5 and the following classification applies. According to the power supply, cold light instrument is divided into. --- Type 1. Power supply via network; --- Type 2. Powered by rechargeable battery.

5 request

5.1 General requirements The cold light meter shall be designed, constructed and manufactured for proper transport, storage, installation, use and maintenance in accordance with the manufacturer's instructions , The cold light meter in the normal use and a single failure state will not be on the patient, the operator or the surrounding environment can be reasonably foreseeable Danger. ......

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