Medical endoscopes — Endotherapy device — Grasping forceps
1 Scope
This standard specifies the scope, terms and definitions, requirements, and test methods of grasping forceps.
This standard is applicable to grasping forceps used in endoscopic surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced documents (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 equipments 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 0149-2006 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
grasping 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 grasping and obtaining human tissue
3.2
insertion portion
component of the grasping 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
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
