1 Scope
This standard specifies the structural types and materials, requirements, test methods, and marking, instructions for use, packaging, transportation and storage for linear staplers.
This standard is applicable to linear staplers (hereinafter referred to as staplers). Staplers are suitable for sewing up the stump and incision of tissues and organs in digestive tract reconstruction and visceral organ resection operations.
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 at ambient temperature
GB/T 230.1 Metallic materials - Rockwell hardness test - Part 1: Test method (Scales A, B, C, D, E, F, G, H, K, N, T)
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 skin sensitization
GB/T 19633 Packaging for terminally sterilized medical devices
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 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) (2015 Edition)
ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
3 Usage state
3.1 Cartridges
Built-in staples can be used only once.
3.2 Reusable stapler
A reusable stapler can be used for multiple operations, together with aseptically packaged cartridges, after the body is repeatedly sterilized and disinfected.
3.3 Disposable stapler
A stapler, with aseptically packaged body, shall be used for a single operation (single patient), together with aseptically packaged cartridges.
Foreword I
1 Scope
2 Normative references
3 Usage state
4 Structural types and materials
5 Requirements
6 Test methods
7 Marking and instructions for use
8 Packaging, transportation, storage and validity period
Annex A (Informative) Test material for stapling performance
Annex B (Normative) Pressure resistance test
Annex C (Normative) Sealing performance test
Annex D (Normative) Peeling strength test
Annex E (Informative) Type inspection
Bibliography
