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

Publish Date: 2023-12-29 Implement Date: 2024-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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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

Word Count: 35 Thousand words Pages: 28 pages

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)

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