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
