Standard No.:	YY/T 0043-2016
English Name:	Medical suture needle
Chinese Name:	医用缝合针
Chinese Classification:	C31    General and microsurgical 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:	2016-03-23
Implemented on:	2017-1-1
Status:	valid
Superseding:	YY 0043-2005 Medical suture needle YY 0666-2008 Method for the test of sharpness and strength of needles tips
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	250.0
Delivery:	via email in 1 business day

YY/T 0043-2016 Medical suture needle 1 Scope This standard specifies the classification, designation and materials, requirements, test methods, inspection rules, packaging, marking and user manual, as well as storage of medical suture needles. This standard applies to medical suture needles (hereinafter referred to as “suture needles”) used for suturing internal organs, soft tissues, skin, and similar purposes. 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 4240 Stainless steel wires GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance YY 0167-2005 Non-absorbable surgical suture YY/T 0171-2008 Surgical instruments - , Packaging, marking and instructions Pharmacopoeia of the People’s Republic of China (Volume II) (2010 Edition)) 3 Classification, designations and materials 3.1 Surgical suture needles are delivered in either sterile or non-sterile condition. 3.2 The forms, curvatures, and holes of the suture needles are specified in Annex A. 3.3 The form, curvature, holes, and specification of a suture needle may be designated by the following methods or expressed in textual form: a) Form designated by text and/or symbols: Circle or "○"; Equilateral triangle or "△"; Inverse-triangle or "▽"; Short-blade triangle or "short-blade △"; Triangular half-bend or "△ half-bend";

Contents Foreword i 1 Scope 2 Normative References 3 Classification, designations and materials 4 Requirement 5 Test method 6 Inspection rules 7 Packaging, marking and user manual 8 Storage Annex A (Informative) Schematic diagrams for forms, curvatures, and eyes of suture needles Annex B (Informative) Schematic diagrams of elasticity and toughness test devices for suture needles Annex C (Normative) Test method for penetration force and strength of needle tips Annex D (Normative) Test method for cutting force of suture needle triangular edges