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YY/T 0955-2014: Medical endoscopes. Endoscope surgical equipment. Shaver
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| YY/T 0955-2014 | English | 259 |
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Medical endoscopes. Endoscope surgical equipment. Shaver
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Basic data | Standard ID | YY/T 0955-2014 (YY/T0955-2014) | | Description (Translated English) | Medical endoscopes. Endoscope surgical equipment. Shaver | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 11,184 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB 9706.1; GB 9706.19; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 14710; GB/T 16886.1; YY/T 0149-2006; YY 91057 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of minimally invasive endoscopic surgery, the rotary shaving their head by rotating the outer portion of the fixed part of the window with the band composed of planing device. Other works of planing device can opt applicab | YY/T 0955-2014: Medical endoscopes. Endoscope surgical equipment. Shaver---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 surgical equipment.Shaver
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic surgical equipment planing device
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
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. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
The standard medical optical instruments by the National Standardization Technical Committee (SAC/TC103/SC1) and focal points.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
Mortem hospital.
The main drafters of this standard. Yan Qing, the JIA Xiao Hang, He Tao, Qi Weiming.
Medical endoscope endoscopic surgical equipment planing device
1 Scope
This standard specifies the rotary planing medical endoscope with the requirements, test methods.
This standard applies to the use of minimally invasive endoscopic surgery, spin their heads shaved by the outer portion of the fixed portion of the rotating band formed within the window
Rotary planing device. Other works of planing device may choose to use suitability.
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 Medical Electrical Equipment Part 1. General requirements for safety
GB 9706.19 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
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
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY 91057 medical foot switch General technical conditions
3 Definitions
The following terms and definitions apply to this document.
3.1
Endoscopic surgical equipment endoscopesurgicalequipment
In the minimally invasive endoscopic diagnosis and/or treatment/surgery, direct mechanical contact with the tissue, or to transfer energy directly to the organization, or to
Organization of surgical instruments delivering energy to provide energy to achieve tissue or foreign bodies minced, planing, cutting, coagulation and other effects of surgery
equipment.
4 Requirements
4.1 No-load speed
4.1.1 pre-load speed of the adjustment range
When planing the pre-load speed is adjustable, the manufacturer shall be given pre-load speed of the adjustment range, and should be planing the pre-load
The actual speed of adjustment is consistent range.
4.1.2 Preset accuracy of load speed
When setting load speed ≥1000r/min, load speed tolerances set for ± 10%; when the set load speed < 1000r/min
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