YY/T 0071-2018Sigmoidoscopy and rectoscopy set (English PDF)
直肠、乙状结肠窥镜
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 21, 2018
Implementation date
September 26, 2019
Scope
YY/T 0071-2018 is the English-translated version of 直肠、乙状结肠窥镜.
YY/T 0071-2018 is the Chinese pharmaceutical industry standard for the sigmoidoscope and rectoscope set used to examine and diagnose anorectal disease.
It gives the terms and definitions, the composition and specifications, the requirements and the test methods, covering the materials and their corrosion resistance, the dimensions and finish of the tubes and obturators, the illumination and the optics, the insufflation connection, the strength of the parts and the cleaning and sterilization of the set. Issued on 21 September 2018, it has applied since 26 September 2019.
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Document preview — YY/T 0071-2018
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
- Replacing
- YY 0071-2008
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Composition and specifications
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).
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 document. 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 Sigmoidoscope and rectoscope
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Editions of YY/T 0071
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0071-2018 | Sigmoidoscopy and rectoscopy set | current edition | Current |
| YY 0071-2008 | Sigmoidoscopy and rectoscopy set | previous edition | Superseded |
This page sells the current edition, YY/T 0071-2018. Earlier editions are listed for reference only.
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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