This document specifies structural types and materials, requirements, test methods, marks, instructions for use and packaging, transportation and storage for linear cutter stapler and cartridge. This Standard applies to linear cutter stapler and cartridge (hereinafter referred to as the stapler). The stapler is suitable for gastrointestinal reconstruction, anastomosis, amputation and resection of tissues and organs in organ resection. This Standard does not apply to the stapler for endoscopic use.
Basic Data
Standard ID
YY 0876-2013 (YY0876-2013)
Description (Translated English)
Linear cutter stapler and cartridge
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the linear cutting stapler and components of structure type and material requirements, test methods, marking, manual and packaging, transport and storage. This standard applies to linear cutting stapler (hereinafter referred to as
