1 Scope
This standard specifies the structural types, materials, requirements, test methods, marking, instructions for use, packaging, transportation and storage for linear cutter staplers and cartridges.
This standard is applicable to linear cutter staplers (hereinafter referred to as staplers). Staplers are suitable for stapling, disconnection and resection of tissues and organs in digestive tract reconstruction and visceral organ resection operations.
This standard is not applicable to staplers used under an endoscope.
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 228 Metallic materials - Tensile testing - Part 1 : Method of test at room temperature
GB/T 1220 Stainless steel bars
GB/T 3280 Cold rolled stainless steel plate, sheet and strip
GB/T 10610 Geometrical product specifications(GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture
GB/T 12672 Acrylonitrile-butadiene-styrene(ABS) resin
GB/T 13810 Wrought titanium and titanium alloy for surgical implants
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
GB/T 19633 Packaging for terminally sterilized medical devices
YY 0167 Non-absorbable surgical suture
YY/T 0171-2008 Surgical instruments - Packaging, marking and instructions
YY/T 0174 Scalpel blade
YY/T 0294.1 Surgical instruments - Metallic materials - Part 1: Stainless steel
HG/T 2503 Polycarbonate resin
Pharmacopoeia of the People's Republic of China (Volume II) (2010 Edition)
ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
3 Structural types and materials
3.1 Staplers can be classified into two types according to the assembly position of the cutting knife: knife on instrument (Type I) and knife on cartridge (Type II).
3.2 A stapler consists of the body and cartridge:
a) The body of a Type I stapler consists of a staple support, a locking rod, a cutting cartridge frame, a cutting knife, etc., and the cartridge consists of a staple bin, a thrust washer, staples, etc.;
b) The body of a Type II stapler consists of a staple support, a locking rod, a cutting cartridge frame, etc., and the cartridge consists of a staple bin, a thrust washer, a cutting knife, staples, etc.
3.3 See Figures 1 and 2 and Table 1 for the structural type and basic dimensions of a stapler and cartridge.
Foreword I
1 Scope
2 Normative references
3 Structural types and materials
4 Requirements
5 Test methods
6 Marking and instructions for use
7 Packaging, transportation and storage
Annex A (Normative) Sharpness test for cutting edge
Annex B (Informative) Test material for stapling performance
Annex C (Normative) Pressure resistance test
Annex D (Informative) Sealing performance test
Annex E (Normative) Peeling strength test
Annex F (Informative) Type inspection
Bibliography
