Medical endoscopes - Endotherapy device - Needle forceps
1 Scope
This standard specifies the scope, terms and definitions, requirements, and test methods of needle forceps.
This standard is applicable to needle 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/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 0043-2005 Medical suture needle
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
needle 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 clamping a suture needle
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
