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YY/T 1446-2016: Medical endoscopes. Endotherapy device. Palmate retractor
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| YY/T 1446-2016 | English | 219 |
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Medical endoscopes. Endotherapy device. Palmate retractor
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YY/T 1446-2016
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Basic data | Standard ID | YY/T 1446-2016 (YY/T1446-2016) | | Description (Translated English) | Medical endoscopes. Endotherapy device. Palmate retractor | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 11,182 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 1962; GB/T 14233.1-2008; GB/T 14233.2; GB/T 16886; YY/T 0149-2006 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the scope, terminology and definition of palm devices, requirements, and test methods. This standard applies to handheld devices used in endoscopic surgery. | YY/T 1446-2016: Medical endoscopes. Endotherapy device. Palmate retractor---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.Endotherapy device.Palmate retractor
ICS 11.040.99
C40
People's Republic of China Pharmaceutical Industry Standard
Medical endoscopic endoscopic instrument palm device
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 requirements 3
5 Test Method 6
6 Inspection rules 8
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1).
The drafting of this standard unit. Zhejiang Medical Device Testing Institute.
The main drafters of this standard. Zhang Qiaoyuan, Jia Xiaohang, Yan Qinglai.
Medical endoscopic endoscopic instrument palm device
1 Scope
This standard specifies the scope, terminology and definition of palm devices, requirements, and test methods.
This standard applies to handheld devices used in endoscopic surgery.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 1962 6% (Ruhr) Cone Joints for Syringes, Syringes and Other Medical Devices
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2 Methods of test for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
Test method for corrosion resistance of stainless steel medical equipment
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Endoscopy device endotherapydevice
In the endoscopic surgery, for the purpose of inspection, diagnosis or treatment, through the endoscope and the same or different channels into the human body hole
Road or surgical incision for medical devices.
Note. Endoscopic instruments include instruments that guide the insertion of endoscopic instruments. Endoscopic instruments also include some used under endoscopic observation for safety purposes
The purpose of entering the instrument from the opening of the human body different from the endoscope.
3.2
Palm device palmateretractor
A rigid endoscopic instrument used in conjunction with a specified endoscope, consisting mainly of handles, rods, joints, and fingers, for holding,
Open the human body cavity (such as the intestine, omentum, etc.), which will help reveal the surgical site. The common structure is shown in Fig.
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