YY/T 1297-2015 Medical endoscopes - Endotherapy device - Curette
1 Scope
This standard specifies the scope, terms and definitions, requirements and test methods of the curette, a kind of endotherapy devices.
This standard is applicable to curette used in endoscopic surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1962 (all parts) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB 9706.4 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
GB 9706.19 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
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 16886 (all parts) Biological evaluation of medical devices
YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
endotherapy device
medical device used in endoscopic surgery for inspection, diagnosis, or treatment, entering natural body orifices or surgical incisions through channels identical or different from those of the endoscope
Note: Endotherapy devices include devices guiding the insertion of endotherapy devices. Devices used when observing with an endoscope, entering the human body from orifices different from those of the endoscope for safety purposes, also fall under the category of endotherapy devices.
3.2
curette
endotherapy device matched with corresponding endotherapy, which is mainly composed of a handle, a rod and a scraping head, and aims to remove target tissues or foreign bodies by scraping or gouging
3.3
insertion portion
component of the curette that can be inserted into a natural body orifice, a surgical incision, a device channel of endoscope, a device channel of endoscope accessory, or a device channel of endotherapy device
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
