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YY/T 0071-2018: Sigmoidoscopy and rectoscopy set
Status: Valid YY/T 0071: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0071-2018 | English | 139 |
Add to Cart
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3 days [Need to translate]
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Sigmoidoscopy and rectoscopy set
| Valid |
YY/T 0071-2018
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| YY 0071-2008 | English | 399 |
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3 days [Need to translate]
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Sigmoidoscopy and Rectoscopy set
| Obsolete |
YY 0071-2008
|
| YY 0071-1992 | English | 199 |
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2 days [Need to translate]
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recta and sigmoid flexure endoscope
| Obsolete |
YY 0071-1992
|
PDF similar to YY/T 0071-2018
Basic data | Standard ID | YY/T 0071-2018 (YY/T0071-2018) | | Description (Translated English) | Sigmoidoscopy and rectoscopy set | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 7,783 | | Date of Issue | 2018-09-21 | | Date of Implementation | 2019-09-26 | | Older Standard (superseded by this standard) | YY 0071-2008 | | Issuing agency(ies) | State Drug Administration | YY/T 0071-2018: Sigmoidoscopy and rectoscopy set---This is a DRAFT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.
Sigmoidoscopy and rectoscopy set
ICS 11.040.99
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0071-2008
Rectal, sigmoid colonoscope
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 0071-2008 "rectal, sigmoid colonoscope", compared with YY 0071-2008, the main technical changes are as follows.
--- Revised dimensional requirements, biocompatibility requirements (see 5.7.3,.2008 version 4.9), corrosion resistance (see 5.8,.2008 edition)
4.7);
--- Added surface material (see 5.7.1), material requirements (see 5.7.2), dissolved precipitates (see 5.7.4), over temperature (see 5.9), Luer connection
Head (see 5.10) requirements;
--- Removed security requirements (see.2008 version 4.8), inspection rules (see Chapter 6 of the.2008 edition), signs (see.2008 edition)
Chapter 7), Instructions for Use (see Chapter 8 of the.2008 edition), packaging (see Chapter 9 of the.2008 edition), transportation and storage
(See Chapter 9 of the.2008 edition) 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.
The previous versions of the standards replaced by this standard are.
---WSZ-244-1977;
---YY 0071-1992;
---YY 0071-2008.
Rectal, sigmoid colonoscope
1 Scope
This standard specifies the terms and definitions, composition and specifications, requirements and test methods for rectal and sigmoid colonoscopes.
This standard is applicable to rectal and sigmoid colonoscopy (hereinafter referred to as speculum) for clinical use in medical institutions. Speculum is mainly used for anorectal examination.
Check and diagnose.
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/T 1962 6% (Ruhr) conical joint for syringes, needles and other medical devices
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
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The rectal and sigmoid colonoscope is a direct-view tube that can be inserted into the human anorectum for examination and diagnosis without an optical imaging structure.
4 Composition and specifications
4.1 Composition
The speculum is mainly composed of a mirror body, a obturator, a handle, an illumination fiber, and an optical cable interface. The outline structure is shown in Figure 1.
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