標(biāo)準(zhǔn)編號:	YY/T 0597-2006
中文名稱:	施夾鉗
英文名稱:	Clip Applicator
中標(biāo)分類:	C31    一般與顯微外科器械
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
ICS分類:	11.040.40 11.040.40    外科植入物、假體和矯形 11.040.40
發(fā)布機構(gòu):	國家食品藥品監(jiān)督管理局
發(fā)布日期:	2006-6-19
實施日期:	2007-5-1
標(biāo)準(zhǔn)狀態(tài):	valid
替代舊標(biāo)準(zhǔn):	YY 0079.3-1992 銀夾鉗
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	9000 字
翻譯價格(元):	700.0
交付時間:	付款后 1 個工作日

YY/T 0597-2006 Clip applicator 1 Scope This standard specifies the types, basic dimensions, materials, requirements, test methods, inspection rules, as well as markings, packaging, transportation and storage for clip applicator. This standard is applicable to surgical clip applicator. This product is used for clamping metal clips. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies. GB/T 230.1 Metallic rockwell hardness test - Part 1:Test method (scales A, B, C, D, E, F, G, H, K, N, T) (GB/T 230.1-2004, ISO 6508.1:1999, MOD) GB/T 1220 Stainless steel bars (GB/T 1220-1992, neq JIS G4303:1988) GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1:1999, IDT) GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 14975 Stainless steel seamless tubes for structures YY 0031-1990 Peritoneal dialysis catheters YY 0079-2006 Implants for surgery - Metallic clip YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance (YY/T 0149-2006, ISO 13402:1995, MOD) YY 0167-2005 Non-absorbable surgical suture YY/T 1052 Marking requirements for surgical instruments 3 Types, basic dimensions, materials 3.1 The type and basic dimensions of the clip applicator shall meet those specified in Figure 1, Figure 2, and Table 1. 3.2 The parts of clip applicator such as the forceps jaws, stem, or handle that come into contact with the human body shall be made of stainless steel materials such as 1Cr18Ni9Ti, 1Cr13, 2Cr13, and 3Cr13 as specified in GB/T 1220 and GB/T 14975.

Foreword i 1 Scope 2 Normative references 3 Types, basic dimensions, materials 4 Requirements 5 Test method 6 Inspection rules 7 Marking 8 Packaging, transportation and storage