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YY 1298-2016 English PDF

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

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US$359.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 1298-2016: Medical endoscopes - Capsule endoscopes
Status: Obsolete

YY 1298: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 1298-2016	359	Add to Cart	3 days	Medical endoscopes - Capsule endoscopes	Obsolete
YY/T 1298-2016	219	Add to Cart	3 days	Medical endoscopes--Capsule endoscopes	Valid

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YY/T 1028 YY 1296 YY 1081 YY/T 1297

Basic data

Standard ID: 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: 9,961
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
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 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

---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.
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

Foreword

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. ......

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Tips & Frequently Asked Questions:

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

Answer: Upon your order, we will start to translate YY 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 1298-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY 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 1298-2016?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 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.