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YY 1298-2016

Search Result of Chinese Standard: 'YY 1298-2016'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 1298-2016English169 Add to Cart Days<=3 Medical endoscopes - Capsule endoscopes Valid YY 1298-2016
YY 1298-2016Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY 1298-2016; YY1298-2016
Description (Translated English): Medical endoscopes. Capsule endoscopes
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.55
Word Count Estimation: 9,960
Date of Issue: 2016-03-23
Date of Implementation: 2018-01-01
Quoted Standard: GB 9706.1; GB 9706.19; GB/T 14233.1-2008; GB/T 14233.2; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16
Drafting Organization: Zhejiang Medical Device Testing Institute, Anhan Optoelectronic Technology (Wuhan) Co., Ltd., Hangzhou Hua Chong Technology Co., Ltd., Chongqing Jinshan Technology (Group) Co., Ltd.
Administrative Organization: National Standardization Subcommittee on Medical Optics and Instruments (SAC/TC 103/SC 1)
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terminology and definitions, requirements, test methods, inspection rules, etc. for capsule endoscopes. This standard applies to capsule endoscopes.


YY 1298-2016
Medical endoscopes - Capsule endoscopes
ICS 11.040.55
C40
People's Republic of China Pharmaceutical Industry Standard
Medical endoscopy capsule endoscope
2016-03-23 release
2018-01-01 implementation
State Food and Drug Administration issued
Preface
Chapter 5 of this standard is recommended and the remainder is mandatory.
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 release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1).
The standard drafting unit. Zhejiang Medical Devices Testing Institute, Anhan Optoelectronic Technology (Wuhan) Co., Ltd., Hangzhou, China Science and Technology Co., Ltd.,
Chongqing Jinshan Technology (Group) Co., Ltd.
The main drafters of this standard. Jia Xiaohang, Zhang Qiaoyuan, Duan Xiaodong, Zhu Ziqiang, Li Xiangdong, Yan Qinglai, He Tao, Zheng Jian.
Medical endoscopy capsule endoscope
1 Scope
This standard specifies the requirements and definitions of capsular endoscopes, requirements, test methods, and inspection rules.
This standard applies to capsule endoscopes.
Note. The capsule endoscope does not contain an external image receiving and processing device or system.
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.
Medical electrical equipment - Part 1. General requirements for safety GB 9706.1
Medical electrical equipment - Part 2. Particular requirements for safety of endoscopic equipment GB 9706.19
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY 0068.1-2008 Medical endoscopic rigid endoscopes - Part 1. Optical properties and test methods
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Capsule endoscope
A kind of capsule shape which is used in combination with an external image receiving and processing device or system for integrating illumination, imaging and wireless transmission.
Endoscopy, mainly used to collect human digestive tract images.
3.2
Distal distal
The optical axis of the capsule endoscope intersects the outer surface of the imaging direction.
3.3
Working distance workingdistance
The distance between the observed object and the end of the capsule endoscope.
4 requirements
4.1 Materials used in contact with the patient
4.1.1 Chemical composition requirements
The material used in contact with the patient should be given in any form possible. Where the metallic material shall indicate the grade and /
Or the code and the chemical composition of the material requirements, the chemical composition of the metal material should be tested to verify.
Related standard:   YY 1296-2016  YY/T 1297-2015
   
 
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