YY 0876-2013 English PDF (YY0876-2013)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY 0876-2013 (Self-service in 1-minute)
Historical versions (Master-website): YY 0876-2013
Preview True-PDF (Reload/Scroll-down if blank)

YY 0876-2013: Linear cutter stapler and cartridge
YY 0876-2013
Linear cutter stapler and cartridge
ICS 11.060.20
C31
People's Republic of China pharmaceutical industry standards
Linear cutter stapler and components
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this standard may involve patents. The standard release
Institutions do not assume the responsibility to identify these patents.
The standard surgical instrument by the National Standardization Technical Committee (SAC/TC94) and focal points.
This standard was drafted. Changzhou City Condit Medical Stapler Co., Ltd., Shanghai Medical Device detection, Jiangsu Province, medical equipment seized
The inspection.
The standard unit of participation. Changzhou Xinghai triple Medical Devices Co., Ltd., Johnson and Johnson (China) Medical Equipment Co., Ltd.
The main drafters of this standard. Yu Guoan, Wengbing Hao, Xing the red.
Linear cutter stapler and components
1 Scope
This standard specifies the linear cutter stapler and components and structure type materials, requirements, test methods, marking, manual and package
Loading, transport and storage.
This standard applies to linear cutter stapler (hereinafter referred to stapler). Stapler suitable for digestive tract reconstruction, organ removal surgery
Anastomosis, amputation and removal of organs.
This standard does not apply to the use of endoscopic stapling.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 228 metal materials at room temperature tensile test method - Part 1. compression fittings
GB/T 1220 stainless steel rods
GB/T 3280 stainless steel cold-rolled steel sheet and strip
GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure
GB/T 12672 acrylonitrile - butadiene - styrene (ABS) resin
GB/T 13810 surgical implants of titanium and titanium alloy materials
GB/T 16886.1 Biological evaluation of medical devices - Part 1; risk management process Evaluation and testing
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
Ethylene oxide sterilization residuals; GB/T 16886.7 Biological evaluation of medical devices - Part 7
GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
GB/T 19633 Packaging for terminally sterilized medical devices
YY 0167 non-absorbable surgical suture
YY/T 0171-2008 surgical instrument packaging, labeling and instructions for use
YY/T 0174 surgical blade
YY/T 0294.1 surgical instrument metallic materials - Part 1. Stainless steel
HG/T 2503 polycarbonate resin
People's Republic of China Pharmacopoeia (2010 edition) two
ISO 13782.1996 Implants for surgery metallic materials for surgical implants pure tantalum material
3 structure type and material
3.1 stapling instrument into the knife (Ⅰ type) and a knife assembly (Ⅱ type) two types according to the assembly position of the cutting knife.
3.2 stapler and from the body of components.
a) Ⅰ stapler nail against the body of the seat, the locking lever and cutter cutting assembly frame and other components, components made staple cartridge, push pieces and staple, etc.
composition;
b) type Ⅱ stapler nail against the body of the seat, the locking lever, the cutting assembly frame and other components, components made staple cartridge, push tablets, cutters and staple, etc.