YY/T 0930-2014Medical endoscopes - Endotherapy device - Cytology brush (English PDF)
医用内窥镜 内窥镜器械 细胞刷
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0930-2014 is the English-translated version of 医用内窥镜 内窥镜器械 细胞刷.
YY/T 0930-2014 is the Chinese pharmaceutical industry standard for the cytology brush, the endotherapy device passed through an endoscope to collect cells from a surface.
It specifies the terms and definitions, the requirements and the test methods, covering the dimensions of the brush and of the sheath and the working length, the retention of the bristles and the strength of the joints, the movement of the brush in its sheath, the corrosion resistance, the materials and their biological evaluation and, where the device is supplied sterile, its sterility.
It applies to brushes sold as a product in their own right. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0930-2014
National Standard of the People's Republic of China
- ICS
- 11.040.90
- 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 terms and definitions brush cells, requirements, test methods.
This standard applies to endoscopic surgery can be used as a standalone product brush cells.
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) 6% for syringes, needles and other medical equipment (Luer) conical fitting
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment - Part 2. Biological test methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY/T 1052-2004 mark surgical instruments
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 Cells brush cytologybrush
One kind of endoscopic instruments used in conjunction with the designated endoscope in endoscopy procedure used to collect a sample of cells needed for pathology Diagnosis.
3.3 Inserting portion
Part of the cells of the brush, the portion can be inserted into the body's natural channels or surgical incision, or insertion of the endoscope instrument channel of the endoscope or instrument The instrument channel.
3.4 Maximum insertion portion width
The maximum width of the outer portion of the insert.
3.5 Working length
The maximum length of the brush cell insertion portion.
......
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 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
- GB/T 16886.1-2011Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0149-2006Medical instruments of stainless steel - Test methods of corrosion resistance
- YY/T 1052-2004Marking requirements for surgical instruments
GB/T 1962
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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 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 1962.1-2015 — Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
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YY/T 0930-2014
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