Standard No.:	YY/T 0943-2014
English Name:	Medical mndoscopes-Endotherapy device-Needle forceps
Chinese Name:	医用内窥镜 内窥镜器械 持针钳
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.99 11.040.99    Other medical equipment 11.040.99
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	4000 words
Translation Price(USD):	164.0
Delivery:	via email in 1 business day

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