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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1298-2016 English PDF

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YY/T 1298-2016: Medical endoscopes--Capsule endoscopes
Status: Valid

YY/T 1298: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1298-2016	English	219	Add to Cart	3 days [Need to translate]	Medical endoscopes--Capsule endoscopes	Valid	YY/T 1298-2016
YY/T 1298-2016	English	219	Add to Cart	3 days [Need to translate]	Medical endoscopes--Capsule endoscopes	Valid	YY/T 1298-2016

PDF similar to YY/T 1298-2016

Standard similar to YY/T 1298-2016

YY 1296 YY 1081 YY 1075 YY/T 1297

Basic data

Standard ID	YY/T 1298-2016 (YY/T1298-2016)
Description (Translated English)	Medical endoscopes--Capsule endoscopes
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C40
Classification of International Standard	11.040.55
Word Count Estimation	10,124
Date of Issue	2016-03-23
Date of Implementation	2018-01-01
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the terms and definitions, requirements, test methods, inspection rules and other requirements for capsule endoscopes. This standard applies to capsule endoscopes. Note: Capsule endoscopes do not include external image receiving and processing devices or systems.

YY/T 1298-2016: Medical endoscopes--Capsule endoscopes

---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.
ICS 11:040:55 C40 Pharmaceutical Industry Standard of the People's Republic of China YY 1298-2016 Medical Endoscope Capsule Endoscope According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on March 23,:2016 2018-01-01 Implementation Issued by China Food and Drug Administration

foreword

Chapter 5 of this standard is recommended, and the rest are mandatory: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by China Food and Drug Administration: This standard is under the jurisdiction of the National Medical Optics and Instruments Standardization Sub-Technical Committee (SAC/TC103/SC1): This standard was drafted by: Zhejiang Medical Device Inspection Institute, Anhan Photoelectric Technology (Wuhan) Co:, Ltd:, Hangzhou Huachong Technology Co:, Ltd:, Chongqing Jinshan Technology (Group) Co:, Ltd: The main drafters of this standard: Jia Xiaohang, Zhang Qinyuan, Duan Xiaodong, Zhu Ziqiang, Li Xiangdong, Yan Qinglai, He Tao, Zheng Jian: YY 1298-2016 Medical Endoscope Capsule Endoscope

1 Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules and other requirements for capsule endoscopes: This standard applies to capsule endoscopes: Note: Capsule endoscopes do not include external image receiving and processing devices or systems:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB 9706:1 Medical Electrical Equipment Part 1: General Safety Requirements GB 9706:19 Medical Electrical Equipment Part 2: Special Requirements for Safety of Endoscopic Equipment GB/T 14233:1-2008 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T 14233:2 Test methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods GB/T 16886 (all parts) Biological evaluation of medical devices YY 0068:1-2008 Medical Endoscope Rigid Endoscope Part 1: Optical Properties and Test Methods

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 Capsule endoscope capsule endoscope A capsule-shaped camera that integrates lighting, imaging, and wireless transmission, used in conjunction with an external image receiving and processing device or system Endoscopes are mainly used to collect images of the human digestive tract: 3:2 terminal distal The part where the optical axis of the capsule endoscope intersects the outer surface of the imaging direction: 3:3 working distance The distance between the observed object and the tip of the capsule endoscope:

4 requirements

4:1 Materials used for patient contact parts 4:1:1 Chemical composition requirements The material used in the parts that come into contact with the patient shall be clearly indicated by the manufacturer in any possible form: Among them, the metal material should be marked with the grade and/or Or code and the chemical composition requirements of the material, the chemical composition of the metal material should be verified by tests: YY 1298-2016

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