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YY/T 1298-2016 English PDF

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Q: Should I purchase the latest version YY/T 1298-2016?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1298-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$219.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1298-2016: Medical endoscopes--Capsule endoscopes
Status: Valid

YY/T 1298: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1298-2016	219	Add to Cart	3 days	Medical endoscopes--Capsule endoscopes	Valid
YY/T 1298-2016	219	Add to Cart	3 days	Medical endoscopes--Capsule endoscopes	Valid

Similar standards

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1298-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1298-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1298-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1298-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 1298-2016?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1298-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.