YY/T 1446-2016Medical endoscopes—Endotherapy device—Palmate retractor (English PDF)
医用内窥镜内窥镜器械掌式器械
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1446-2016 is the English-translated version of 医用内窥镜内窥镜器械掌式器械.
YY/T 1446-2016 is the Chinese pharmaceutical industry standard for the palmate retractor, the endotherapy device passed through an endoscope to hold tissue aside during endoscopic surgery.
It specifies the scope, the terminology and definitions, the requirements and the test methods, covering the dimensions of the insertion portion and the working length, the opening and closing of the fingers and the force needed for it, the strength of the device and of its joints, the corrosion resistance and the materials and their biological evaluation. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1446-2016
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 requirements
- 5 Test Method
- 6 Inspection rules
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
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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 14233.2-2025 — Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
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YY/T 1446-2016
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