YY/T 0944-2014 Medical endoscopes - Endotherapy device - Separating forceps
1 Scope
This standard specifies the scope, terms and definitions, requirements, and test methods of separating forceps.
This standard is applicable to separating forceps 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 4340.1-2009 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 - Part 1: Evaluation and testing
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY 0167-2005 Non-absorbable surgical suture
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
separating forceps
a type of endotherapy device intended to be used in conjunction with specified endoscopes, primarily consisting of a handle, forceps shaft, and forceps jaws, utilized for separating tissues at surgical parts of the human body
3.2
insertion portion
component of the separating forceps 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
3.3
maximum insertion portion width
maximum external width of the insertion portion
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
