YY/T 0070-2018 English PDF

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YY/T 0070-2018: Esophagoscope
Status: Valid

YY/T 0070: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0070-2018	179	Add to Cart	3 days	Esophagoscope	Valid
YY 0070-2008	439	Add to Cart	3 days	Esophagoscope	Obsolete
YY 0070-1992	199	Add to Cart	2 days	Esophagus endoscope	Obsolete

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YY 0068.4   YY 0069   YY 0068.2   YY/T 0071   YY/T 0065   

Basic data

Standard ID: YY/T 0070-2018 (YY/T0070-2018)
Description (Translated English): Esophagoscope
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.99
Word Count Estimation: 9,993
Date of Issue: 2018-09-21
Date of Implementation: 2019-09-26
Older Standard (superseded by this standard): YY 0070-2008
Issuing agency(ies): State Drug Administration

YY/T 0070-2018: Esophagoscope

---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.
Esophagoscope ICS 11.040.99 C40 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0070-2008 Esophageal speculum Published on.2018-09-21 Implementation of.2019-09-26 State Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0070-2008 "Esophagus speculum", and the main technical differences with YY 0070-2008 are as follows. --- Revised size requirements (see 5.1,.2008 version 4.1), biocompatibility requirements (see 5.7.3,.2008 version 4.7), corrosion resistance Corrosion performance (see 5.8,.2008 edition 4.8), electrical safety requirements (see 5.12,.2008 edition 4.9); --- Added surface material (see 5.7.1), material requirements (see 5.7.2), dissolved precipitates (see 5.7.4), fiber optic cable (see 5.9), embedded Requirements for light source (see 5.10) and over temperature (see 5.11); --- Removed the inspection rules (see 6 of the.2008 edition), the logo (see 7 of the.2008 edition), the instruction manual (see 8 of the.2008 edition), Packaging, transport and storage (see.2008 edition 9) and Appendix A (see Appendix A of the.2008 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Optics and Instruments (SAC/TC103/SC1). This standard was drafted. Zhejiang Medical Device Inspection Institute, Zhejiang Tiansong Medical Devices Co., Ltd. The main drafters of this standard. Zhang Yiyuan, Jia Xiaohang, Yan Qinglai, Liu Ping, Shu Mingquan, Xu Binfeng. This standard replaces YY 0070-2008. The previous versions of YY 0070-2008 were released as follows. ---WS2-110-1974, WS2-111-1974; ---YY 0070-1992. Esophageal speculum

1 Scope

This standard specifies the terms and definitions, classification and specifications, requirements and test methods for esophageal endoscopy. This standard is applicable to esophageal speculum (hereinafter referred to as speculum) for clinical use in medical institutions. Speculum is mainly used for the examination and diagnosis of esophagus.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.19 Medical electrical equipment - Part 2. Particular requirements for safety of endoscopes GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1 GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments YY 0763 Optical cable for medical endoscope lighting YY 1081-2011 Medical endoscope endoscope function supply device cold light source

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 The esophagus speculum is a direct-view tube that can be inserted into the human esophagus for examination and diagnosis without an optical imaging structure.

4 Classification and specifications

4.1 Classification 4.1.1 Built-in lighting speculum It is mainly composed of a mirror body, a handle, an embedded light source or an illumination fiber, and a cable connector. The outline structure is shown in Figure 1. 4.1.2 External lighting speculum It mainly consists of a mirror body, a handle, an optical cable and its passage. The outline of the structure is shown in Figure 2. ......

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