GB 8662-1988
Replaced
T/CSBME 073-2023
Active
Group standards
T/CSBME 073-2023 Disposable electric laparoscopic cutting anasthetic instrument and components
T/CSBME 073-2023 Disposable electric laparoscopic cutting anasthetic instrument and components
Price:
$ 49.00
Basic Information
Standard Code:
T/CSBME 073-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Other specialized equipment
ICS Name:
Surgical instruments and materials
Publish Date:
2023-12-29
Implement Date:
2024-03-01
Pages:
28 pages
Scope
This document specifies the basic requirements, technical requirements, test methods, labels, instructions, and packaging for single-use electric endoscopic cutting and anastomosing staplers and components (hereinafter referred to as "electric staplers") used in endoscopic surgery.
This document is applicable to single-use electric endoscopic cutting and anastomosing staplers and components used in endoscopic surgery.
Note: This electric stapler is suitable for creating anastomosis and closing the residual ends or incisions during reconstruction of the digestive tract and organ resection surgeries.
Development Information
Referenced Standards
GB/T 228.1-2010 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 228.1-2021 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 1220-1992 Stainless steel bars
GB/T 1220-2007 Stainless steel bars
GB/T 3280-1992 Cold rolled stainless steel sheets and plates
GB/T 3280-2007 Cold rolled stainless steel plate, sheet and strip
GB/T 3280-2015 Cold rolled stainless steel plate, sheet and strip
GB/T 4237-1992 Hot rolled stainless steel sheets and plates
GB/T 4237-2007 Hot rolled stainless steel plate, sheet and strip
GB/T 4237-2015 Hot rolled stainless steel plate,sheet and strip
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 13810-1997 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing
JTG B01-2014
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
YY 0876-2013 Linear cutter stapler and cartridge
YY/T 1797-2021 Endoscopic surgical instruments—Endoscopic cutter stapler and reload
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
中华人民共和国药典(2020年版)
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced