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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0875-2023: Surgical instrument - Linear stapler and cartridge Status: Valid YY 0875: Historical versions
Basic dataStandard ID: YY 0875-2023 (YY0875-2023)Description (Translated English): Surgical instrument - Linear stapler and cartridge Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C31 Classification of International Standard: 11.060.20 Word Count Estimation: 18,175 Date of Issue: 2023-09-05 Date of Implementation: 2026-09-15 Older Standard (superseded by this standard): YY 0875-2013; YY 0876-2013 Issuing agency(ies): State Drug Administration Summary: This standard specifies the structural type and materials, requirements, test methods, labels, instructions and packaging of linear staplers. This standard applies to linear staplers and components. This document does not apply to special vascular staplers, curved staplers and staplers used under laparoscopy. YY 0875-2023: Surgical instrument - Linear stapler and cartridge---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS 11.060.20 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Replace YY 0875-2013, YY 0876-2013 Surgical instruments linear staplers and components Published on 2023-09-05 Implemented on 2026-09-15 Released by the State Drug Administration ForewordThis document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY 0875-2013 "Linear Staplers and Components" and YY 0876-2013 "Linear Cutting Staplers and Components". Compared with YY 0875-2013 and YY 0876-2013, the main technical differences are as follows. ---Changed the scope and added "This document does not apply to special vascular staplers and curved staplers" (see Chapter 1, YY 0875- 2013, Chapter 1 of YY 0876-2013); ---Added product types (see 4.1); ---Deleted the requirements for main parts and materials of staplers and components (see 4.5 of YY 0875-2013, 3.4 of YY 0876-2013); ---Changed the requirements for specification marking and added marking examples of unequal height staples (see 4.3, 4.6 of YY 0875-2013, 3.5 of YY 0876-2013); ---Added a note on staple materials, clarifying that staples can also use materials that have been verified and evaluated as safe (see 5.1); ---Changed the requirements for surface roughness (see 5.4, 5.7 of YY 0875-2013, 4.8 of YY 0876-2013); --- Added requirements for Vickers hardness of the nail base (see 5.6.1); --- Added requirements and test methods for cutting knife hardness (see 5.6.2 and 6.6.2); ---Changed the requirements for the length of the anastomosis line and limited the stapler with digestive tract reconstruction function (see 5.10.2, YY 0876-2013 4.5.3); ---Changed the requirements for safety devices, limiting staplers with cutting functions (see 5.13, 4.7 of YY 0876-2013); ---Deleted the requirements and test methods for packaging sealing (see 5.9, 6.9, Appendix C and Appendix D of YY 0875-2013, 4.9, 5.9, Appendix D and Appendix E of YY 0876-2013); ---Added chemical performance requirements and test methods (see 5.16, 6.16); ---Changed the requirements for biological evaluation (see 5.17, 5.13 of YY 0875-2013, 5.13 of YY 0876-2013); ---Added test method for anastomosis line length (see 6.10); ---Deleted the requirements for transportation and storage (see 8.2 of YY 0875-2013, 7.2 of YY 0876-2013); ---Changed the requirements for labels and instructions (see Chapter 7, Chapter 7 of YY 0875-2013, Chapter 6 of YY 0876-2013); ---Changed the cutting knife edge sharpness test method (see Appendix B, Appendix A of YY 0876-2013); ---Changed the voltage resistance test method (see Appendix C, Appendix B of YY 0875-2013, Appendix C of YY 0876-2013). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Surgical Instruments Standardization Technical Committee (SAC/TC94). The previous versions of the documents replaced by this document are as follows. ---YY 0875-2013, YY 0876-2013. Surgical instruments linear staplers and components1 ScopeThis document specifies the structural type and materials, requirements, test methods, labels, instructions and packaging of linear staplers. This document applies to linear staplers and components. Note. This stapler is suitable for suturing the stumps and incisions of tissues and organs during organ resection operations, as well as for anastomosis, disconnection and incision during digestive tract reconstruction and organ resection operations. Remove tissues and organs. This document does not apply to special vascular staplers, curved staplers and staplers used under laparoscopy.2 Normative reference documentsThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 228.1 Tensile testing of metallic materials Part 1.Room temperature test method GB/T 230.1 Rockwell hardness test of metallic materials Part 1.Test methods GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test methods GB/T 6682-2008 Specifications and test methods for water used in analytical laboratories GB/T 10610 Product Geometric Specification (GPS) Rules and methods for surface structure assessment by surface structure profiling method GB/T 13810 Titanium and titanium alloy processed materials for surgical implants GB/T 14233.1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments YY 0167 non-absorbable surgical suture YY/T 0966 Surgical implant metal material pure tantalum ISO 13782 Metallic materials for surgical implants Pure tantalum materials for surgical implants (Implantsforsurgery-Metalic Pharmacopoeia of the People's Republic of China (2020 Edition) Part Four3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 componentcartridge Built-in staples are only used once. 3.2 reusablestapler reusablestapler The device has been repeatedly sterilized and used in multiple surgeries and is used with sterile packaged components. ...... |
