YY/T 0880-2013Breast localization wire and introducer needle for single use (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

Introduction

In 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.

1 Scope

This 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 references

The 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.

3 Terms and Definitions

The following terms and definitions apply to this document.