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YY/T 0070-2018Esophagoscope (English PDF)

食管窥镜

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 21, 2018

Implementation date

September 26, 2019

Scope

YY/T 0070-2018 is the English-translated version of 食管窥镜.

YY/T 0070-2018 is the Chinese pharmaceutical industry standard for the oesophagoscope, the rigid instrument used to examine and diagnose disease of the oesophagus.

It gives the terms and definitions, the classification and the specifications, the requirements and the test methods, covering the materials and their corrosion resistance, the dimensions and the finish of the tube and its distal end, the illumination and the optical performance, the strength of the assembly and the ability of the instrument to be cleaned and sterilized. Issued on 21 September 2018, it has applied since 26 September 2019.

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Document preview — YY/T 0070-2018

National Standard of the People's Republic of China

ICS: 11.040.99
Classification: C 40
Replacing: YY 0070-2008

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and specifications

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).

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 document. 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 Esophagoscope

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 16886

Editions of YY/T 0070

Edition	Title	Revision	Status
YY/T 0070-2018	Esophagoscope	current edition	Current
YY 0070-2008	Esophagoscope	previous edition	Superseded

This page sells the current edition, YY/T 0070-2018. Earlier editions are listed for reference only.

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