Standard No.:	YY/T 0944-2014
English Name:	Medical endoscopes―Endotherapy device―Separating forceps
Chinese Name:	医用内窥镜 内窥镜器械 分离钳
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
Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	160.0
Delivery:	via email in 1 business day

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