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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0880-2013: Breast localization wire and introducer needle for single use Status: Valid
Basic dataStandard ID: YY/T 0880-2013 (YY/T0880-2013)Description (Translated English): Breast localization wire and introducer needle for single use Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C36 Classification of International Standard: 110.40.30 Word Count Estimation: 14,116 Quoted Standard: GB 15811; GB 18457-2001; YY 0450.1-2003; YY/T 0466.1 Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the use of disposable needles breast positioning guide wire and its requirements. Breast positioning device can operate automatically, and can re-enter and re-positioning of the breast to locate the wire does not belong to the scop YY/T 0880-2013: Breast localization wire and introducer needle for single use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Breast localization wire and introducer needle for single use ICS 110.40.30 C36 People's Republic of China pharmaceutical industry standards Disposable breast positioning guide wire and needle Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard by the National Standardization Technical Committee medical infusion apparatus (SAC/TC106) centralized. This standard was drafted. Shandong Medical Devices Product Quality Inspection Center. Participated in the drafting of this standard. Bard Medical Technology (Shanghai) Co., Ltd. Weihai Jie Swiss medical products. The main drafters of this standard. Xu Hui, Sun Haipeng, Song Jinzai, Yuan Jie, Zhou Lei.IntroductionIn order to facilitate the clinical breast partial resection of small lesions in X-ray or ultrasound with breast lesion localization wire and guide for Positioning, clinical surgeon to give clear guidance to narrow incision, reduce surgical trauma. Mammary available on the market a wide range of wire, in the form of material and barbed more diverse, this is not specifically regulated in this standard Scheduled to take place in the clinical course of the use of transverse, bending, loss and risk of puncturing internal organs to minimize design principles, which are provided for in this standard Material appendix (Appendix A) given in the form instructions. This standard specifies the requirements for wire localization of breast and gives a uniform evaluation of breast positioning wire anchoring force performance specifications and test methods. Preoperative localization of other parts of the soft tissue products can refer to this standard. Disposable breast positioning guide wire and needle1 ScopeThis standard specifies the use of disposable breast positioning guide wire and needle requirements. Breast positioning device can be automatically operated and can be repeated The new recovery and repositioning mammary wire outside the scope of this standard.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 15811-time use of sterile needles GB 18457-2001 manufacture of medical devices with a stainless steel needle YY 0450.1-2003 Disposable Sterile intravascular catheters accessories - Part 1. guide instrument Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Location wire Surgery for local breast lesions (lesions) and pre-positioned to guide the surgeon accurately and quickly reach the lesion (lesions) flexible instrument. 3.2 Guide needle The sharp tip of a rigid tube, through which the wire can be guided into the positioning of breast lesions. 3.3 Positioning mark Is used to indicate the position of the positioning hook wire localization, that is the position indicating mark breast lesions. NOTE. positioning mark should touch the structural design, and can be detected in X-ray and/or ultrasound. 3.4 Operation flag Located used to indicate the exact location of positioning the guide wire positioning hook needle localization wire on to help doctors determine the positioning hook wire localization Are mammary released tag. Note. The operation marked and generally use visual and/or structural design palpable. Location wire can have two operations mark, a mark indicating the positioning of the wire Head-end and guide the needle tip alignment, another indication positioning pins have been extended; it can be a continuous operation marks the boundary line two operations mark Also capable of indicating the position of the guide needle positioning hook in to achieve the release operation. 3.5 Positioning hook barb The locating wire head end (patient end) or close to, once designed to extend the positioning wire can only move in one direction or immovable structures design. Note. The common wire positioning double hook with a single hook type and type. ...... |
