YY/T 0864-2011 English PDF (YYT0864-2011)

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YY/T 0864-2011: Medical endoscopes - Endoscope functional supply units - Irrigation pump
YY/T 0864-2011
Medical endoscopes - Endoscope functional supply units - Irrigation pump
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic functional supply means
Liquid expansion chamber pump
Irrigationpump
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, He Tao, Qi Weiming, Zhang Patio, Zheng.
Medical endoscope endoscopic functional supply means
Liquid expansion chamber pump
1 Scope
This standard provides for the expansion of medical endoscope with a liquid pump chamber (hereinafter referred to as the expansion chamber pump) requirements.
This standard applies to expansion cavity pumps used in endoscopic surgery. The products are used in minimally invasive endoscopic surgery in the expansion chamber.
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 14710-2009 medical electrical environmental requirements and test methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Risk Evaluation and testing process
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
YY 0709-2009 Medical electrical equipment - Part 1-8. General requirements for safety Collateral standard. General requirements for medical electrical equipment
Equipment and medical electrical systems alarm systems and test guidelines
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 Pressure limit
4.1.1 preset pressure adjustment range limit
If the preset limit pressure pump adjustable expansion chamber, the manufacturer shall give the preset limit pressure adjustment range, and with the expansion chamber should pump pressure preset limit
The actual adjustment range is consistent.
4.1.2 Pressure limits preset accuracy
When the set pressure limit ≥6650Pa (50mmHg), the pressure tolerance limit set for ± 5%; when the set pressure limit < 6650Pa