YY/T 0245-2008 General specifications for stapler
1 Scope
This standard specifies the classification and type, requirements, test methods, inspection rules, as well as marking, instructions for use, packaging, transportation and storage of staplers.
This standard is applicable to applicable to reusable and disposable staplers, which are used for installing assemblies on staplers for circular tubular incision anastomosis, circular resection anastomosis of the superior hemorrhoid mucosa, or closure and suture of the stump incision.
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 to this standard. 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 of the normative document referred to 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 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 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method (GB/T 4340.1-1999; eqv ISO 6507-1:1997)
GB 9969.1 General principles for preparation of instructions for use of industrial products
GB 12672 Acrylonitrile-butadiene-styrene (ABS) resin
GB/T 13810 Wrought titanium and titanium alloy for surgical implants (GB/T 13810-1997; eqv ISO 5832-2:1993)
GB/T 15076 Methods for chemical analysis of tantalum and niobium
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (GB/T 16886.5-2003; ISO 10993-5:1999, IDT)
GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (GB/T 16886.7-2001; ISO 10993-7:1995, IDT)
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (CB/T 16886.10-2005; ISO 10993-10:2002, IDT)
YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance (YY/T 0149-2006; ISO 13401:1995, MOD)
YY/T 1052 Marking requirements for surgical instruments
YY 0466 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (YY 0466-2003; ISO 15223:2000, IDT)
Pharmacopoeia of the People's Republic of China (Edition 2005)
3 Classification and type
3.1 The types and basic dimensions of staplers shall be as specified in the corresponding product standards.
3.2 The main parts of the staplers shall be made of materials that comply with those specified in Table 1 or other materials that meet the requirements of Clause 4.
Table 1 Materials
Foreword i
1 Scope
2 Normative references
3 Classification and type
4 Requirements
5 Test methods
6 Inspection rules
7 Marking and instructions for use
8 Packaging, transportation and storage
Annex A (Normative) Stapling stoma pressure test method
Annex B (Normative) Test method for peel strength
