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YY/T 0863-2011: Medical endoscopes. Endoscope functional supply units. Roller irrigation and suction equipment
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| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| YY/T 0863-2011 | English | 189 |
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Medical endoscopes. Endoscope functional supply units. Roller irrigation and suction equipment
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Standard similar to YY/T 0863-2011
YY/T 0864 | YY 0847 | YY 0843 | YY 0861 | YY/T 0862 | YY/T 0871 | Basic data
| Standard ID | YY/T 0863-2011 (YY/T0863-2011) |
| Description (Translated English) | Medical endoscopes. Endoscope functional supply units. Roller irrigation and suction equipment |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C40 |
| Classification of International Standard | 11.040.99 |
| Word Count Estimation | 8,837 |
| Date of Issue | 2011-12-31 |
| Date of Implementation | 2013-06-01 |
| Quoted Standard | GB 9706.1-2007; GB 9706.19-2000; GB/T 14233.2-2005; GB/T 14710; GB/T 16886.1; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005 |
| Regulation (derived from) | State Food and Drug Administration Notice No. 106 of 2011 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies requirements for medical endoscope with Roller wash aspirator (hereinafter referred to rinse suction) requirements. This standard applies to those used in endoscopic surgery Roller wash aspirator. The products are used in minimally invasive endoscopic surgery flushing and attractive. |
YY/T 0863-2011: Medical endoscopes. Endoscope functional supply units. Roller irrigation and suction equipment
---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.
Medical endoscopes.Endoscope functional supply units.Roller irrigation and suction equipment
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic functional supply means
Roller washing aspirator
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
The inspection.
The main drafters of this standard. Yan Qing, the JIA Xiao Hang, Qi Weiming, He Tao, Chen Sheng come.
Medical endoscope endoscopic functional supply means
Roller washing aspirator
1 Scope
This standard provides for the medical endoscope Roller wash aspirator (hereinafter referred to as flushing sucker) requirements.
This standard applies to endoscopic surgery Roller wash used in the attractor. The products are used in minimally invasive endoscopic surgery and rinse
attract.
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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.19-2000 electrical equipment - Part 2. Safety of endoscopic equipment
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 14710 medical electrical environmental requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Functional endoscopic supply means endoscopefunctionalsupplyunits
In the minimally invasive endoscopic diagnostic and (or) treatment/surgery, providing apparatus or equipment support functions.
4 Requirements
4.1 Structural requirements
Rinse aspirator should be configured to have both flushing and compelling features.
4.2 Pressure limit
4.2.1 preset pressure adjustment range limit
If the flushing attract the preset pressure limit is adjustable, the manufacturer shall give the preset limit pressure adjustment range, and should be flush with the sucker preset
The actual pressure limit adjustment range consistent.
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