Standard No.:	YY/T 1472.1-2016
English Name:	Thoracic minimally invasive instruments—Part 1:Dual pivot surgical clamps
Chinese Name:	胸科小切口器械 第1部分：滑板式手术钳
Chinese Classification:	C36    Other special devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	240.0
Delivery:	via email in 1 business day

YY/T 1472.1-2016 Thoracic minimally invasive instruments - Part 1: Dual pivot surgical clamps 1 Scope This part of YY/T 1472 specifies the classification, requirements, test methods, inspection rules, marking and instructions for use, packaging, transportation and storage requirements for dual pivot surgical clamps. This part is applicable to dual pivot surgical clamps (hereinafter referred to as clamps) for mini-thoractomy: ——Minimally invasive tissue clamp, for clamping tissues and organs, such as lung lobes and lymph nodes; ——Minimally invasive separation ligation clamp, for separating target organs, such as blood vessels and tissues; ——Minimally invasive vascular clamp, for clamping and blocking blood vessels; ——Minimally invasive needle clamp, for clamping a suture needle. 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 4237-2015 Hot rolled stainless steel plate, sheet and strip GB/T 4240-2009 Stainless steel wires GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method GB 7543-2006 Single-use sterile rubber surgical gloves GB/T 8938-2008 Typewriting paper GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process GB 19790.2-2005 Disposable chopsticks - Part 2: Bamboo chopsticks BB/T 0014-2011 Grip bag YY/T 0031-2008 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance YY 0167-2005 Non-absorbable surgical suture YY/T 0173.4-2005 Surgical instruments - Teeth, serration, ratchet and elliptoid ring YY/T 1052-2004 Marking requirements for surgical instruments 3 Product classification 3.1 Structural type 3.1.1 Clamps include minimally invasive tissue clamp, minimally invasive separation ligation clamp, minimally invasive vascular clamp and minimally invasive needle clamp (hereinafter referred to as tissue clamp, separation ligation clamp, vascular clamp and needle clamp). 3.1.2 A clamp is mainly composed of clamp head, sliding rod, fixed rod, handle, box joint shaft for handle joint and box joint shaft for clamp head joint. The handles are classified into two types: ring handles (with or without locking teeth) and spring handles (with locking teeth), as shown in Figure 1. The clamp heads may be made to be straight, curved or 90° curved, as shown in Figure 2. The working face of a clamp may be made to be toothless, toothed or with reticulated teeth, as shown in Table 1. The clamp structure may also be designed and determined by the manufacturer itself.  

Foreword II Introduction III 1 Scope 2 Normative references 3 Product classification 4 Requirements 5 Test methods 6 Marking and instructions for use 7 Packaging, transportation and storage Annex A (Normative) Clamping performance test for vascular clamps Annex B (Normative) Clamping and blocking performance test for vascular clamps