YY/T 1415-2016Skin stapler (English PDF)

1 Scope

This Standard specifies the classification, requirements, test methods, type inspection rules, marking, instructions for use, packaging, transportation and storage of disposable skin staplers.

This Standard applies to disposable skin staplers (hereinafter referred to as the "skin staplers") used in surgical procedures for suturing pre-cut skin and epidermal tissue.

2 Normative References

The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.

GB/T 223.1 ~ 223.83 Methods for Chemical Analysis of Iron, Steel and Alloy (series standards)

GB/T 3280-2007 Cold Rolled Stainless Steel Plate, Sheet and Strip

GB/T 4234-2003 Stainless Steel for Surgical Implants

GB/T 4240-2009 Stainless Steel Wires

GB/T 4340.1-2009 Metallic Materials - Vickers Hardness Test - Part 1: Test Method

GB/T 16886.5-2003 Biological Evaluation of Medical Devices - Part 5: Test 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/T 0171-2008 Surgical Instruments - Packaging, Marking and Instructions

YY/T 0466.1-2009 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements

YY/T 0681.4-2010 Test Methods for Sterile Medical Device Package - Part 4: Detecting Seal Leaks in Porous Packages by Dye Penetration Pharmacopoeia of the People's Republic of China (2010 Edition - Volume II)

3 Classification

3.1 The types and basic dimensions of skin staplers are shown in Figure 1 and Table 1.

4 Requirements

4.1 The chemical composition of the stainless-steel materials 022Cr17Ni12Mo2 and 00Cr18Ni14Mo3 used to manufacture the suture staples shall respectively comply with the provisions of GB/T 4240-2009 and GB/T 4234-2003.

4.2 During use, all moving components of the skin stapler shall smoothly move without jamming, staple sticking, or loosening.

4.3 The skin stapler shall have good suturing performance. All loaded suture staples shall normally fire and, after firing, shall smoothly penetrate the test material to form a rectangle, and there shall be no twisting or deformation.

4.4 The formed suture staples shall be easily removed, and the surface of the test material shall be free from damage.

4.5 The hardness of the press board and staple holder shall not be less than 330 HV0.2.

4.6 The suture staples shall have good corrosion resistance, and after testing, their surface condition shall not be lower than Grade 5.4 b in YY/T 0149-2006.

4.7 The aseptic packaging shall be intact, and the adhesive sealing area shall be free of channels or perforations.

4.8 The peel strength of the packaging seal shall not be less than 0.10 N/mm. During peeling, the two contact surfaces shall be smooth and continuous and uniform, without delamination or tearing.

4.9 The skin stapler shall have a smooth shape, clear outline, and be free of burrs, scratches or other defects.

4.10 The lettering and markings on the surface of the skin stapler shall be clear, and the labels shall be correctly affixed, without misalignment, skewness or other defects.

4.11 The staple head shall be sharp, and the staple surface shall be smooth, free of burrs, dents or other defects.

4.12 The basic dimensions of the skin stapler shall conform to the specifications in Figure 1 and Table 1.

4.13 The number of staples loaded onto the skin stapler shall match the indicated number to avoid missing staples.

4.14 The skin stapler shall be sterilized using a validated sterilization process, and the product shall be sterile.

4.15 If ethylene oxide sterilization is used, the residual ethylene oxide content of the skin stapler shall not exceed 10 µg/g.

4.16 The cytotoxicity score of the staples shall not exceed 1.

4.17 The delayed hypersensitivity reaction grade of the staples shall not exceed Grade 1.

4.18 The intradermal reaction score of the staples shall not exceed 1.

5 Test Methods

5.1 The chemical composition test of the stainless-steel staple materials shall be conducted in accordance with the methods specified in GB/T 223.1 ~ GB/T 223.83 or equivalent methods and shall comply with the provisions of 4.1.

5.2 Simulate the action of use, fire, and then release the handle, and it shall comply with the provisions of 4.2.

5.3 Simulate the action of use, sew together a test material with a total thickness of approximately 3 mm, consisting of a layer of simulated skin and a layer of EVA low-foaming board. Along the edge of the formed suture staple, remove excess simulated skin and EVA low-foaming board, expose the formed suture staple. Use normal or corrected vision to examine it, which shall conform to the provisions of 4.3.

NOTE. simulated skin material.

a) Material. polyurethane film;

b) Thickness. 0.35 mm ± 0.05 mm;

c) Hardness. Shore A 85 ± 10.