Standard No.:	YY 0875-2013
English Name:	Linear stapler and cartridge
Chinese Name:	直线型吻合器及组件
Chinese Classification:	C36    Other special devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	to be superseded
Superseded by:	YY 0875-2023 Surgical instrument--Linear stapler and cartridge
Superseded on:	2026-9-15
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	250.0
Delivery:	via email in 1 business day

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