YY 0876-2013 (English Version) PDF

Scope: This standard specifies the structural type and materials, requirements, test methods, markings, instructions for use, packaging, transportation and storage of linear cutting staplers and components. This standard applies to linear cutting staplers (hereinafter referred to as staplers). The stapler is suitable for anastomosis, separation and removal of tissues and organs during digestive tract reconstruction and organ resection operations. This standard does not apply to staplers used under laparoscopy.

YY 0876-2013 Referenced Document

GB/T 10610 Geometrical Product Specifications(GPS)Surface texture:Profile method.Rules and procedures for the assessment of surface texture
GB/T 1220 Stainless steel bars
GB/T 12672 Acrylonitrile-butadiene-styrene(ABS) resin
GB/T 13810 Wrought titanium and titanium alloy for surgical implants*， 2017-10-14 Update
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
GB/T 19633 Packaging for terminally sterilized medical devices
GB/T 228 Metallic materials--Tensile testing at ambient temperature
GB/T 3280 Cold rolled stainless steel plate, sheet and strip*， 2015-09-11 Update
HG/T 2503 polycarbonate resin*， 2022-09-30 Update
ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
YY 0167 non-absorbable surgical sutures*， 2020-02-26 Update
YY/T 0171-2008 Surgical instruments.Packaging，Marking and Instructions
YY/T 0174 Scalpel blade*， 2019-05-31 Update
YY/T 0294.1 Surgical instruments.Metallic materials.Part 1:Stainless steel*， 2016-03-23 Update

YY 0876-2013 Linear cutter stapler and cartridge was changed to YY 0875-2023 Surgical instruments linear staplers and components.