YY/T 1297-2015Medical endoscopes—Endotherapy device—Curette (English PDF)
医用内窥镜 内窥镜器械 刮匙
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1297-2015 is the English-translated version of 医用内窥镜 内窥镜器械 刮匙.
YY/T 1297-2015 is the Chinese pharmaceutical industry standard for the curette used as an endotherapy device with an endoscope in surgery.
It specifies the scope, the terms and definitions, the requirements and the test methods, covering the dimensions and the working length, the form and the edge of the spoon, the strength of the instrument and of its joints, the corrosion resistance, the materials and their biological evaluation and the ability of the instrument to be cleaned and sterilized. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1297-2015
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the endoscopic instrument curette scope, terms and definitions, requirements, test methods.
This standard applies to the use of endoscopic surgical curette.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962 (all parts) syringes, needles and other medical equipment - 6% (Luer) conical fitting
GB/T 4340.1 metallic materials - Vickers hardness test - Part 1. Test methods
GB 9706.4 Medical electrical equipment - Part 2-2.
GB 9706.19 Medical electrical equipment - Part 2. Safety of endoscopic equipment
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY/T 0149 stainless steel medical equipment corrosion test methods
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Endoscopic instruments endotherapydevice
In endoscopic surgery, to check, diagnostic or therapeutic purposes, and the endoscope through the same or different channels to enter the body's natural hole Tract or surgical incision medical devices.
NOTE: Some endoscopic instruments include an endoscopic instrument to guide the instrument inserted. Some endoscopic instruments are also included in the observation using the endoscope, for safety Purposes different from the endoscope into the opening of the body of the instrument.
3.2 Curette
One kind with the corresponding endoscope with an endoscopic instrument used mainly by the handle, shank, head shaving composition to Sao scrape or cut out scraping way to remove Target tissue or foreign bodies.
3.3 Inserting portion
Part of the curette, which is partially inserted into the human or natural orifice surgical incision, or insertion of the endoscope instrument channel, or endoscopic accessory Instrument channel, instrument channel of the endoscope or instrument.
3.4 Maximum insertion portion width
The maximum width of the outer portion of the insert.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 4340.1Metallic materials - Vickers hardness test - Part 1: Test method
- GB 9706.4Medical electrical equipment -- Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
- GB 9706.19Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- YY/T 0149Medical instruments of stainless steel - Test methods of corrosion resistance
GB/T 1962
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Related Standards
GB 9706.19-2000 — Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
GB 9706.4-2009 — Medical electrical equipment -- Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
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YY/T 1297-2015
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