Medical endoscopes — Endotherapy device — Punch forceps
1 Scope
This standard specifies the scope, terms and definitions, requirements and test methods of punch forceps.
This standard is applicable to punch 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 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 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
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
punch 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 seizing and cutting tissue
Note: This tissue does not include bone tissue.
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
