Search result: YY 0875-2023 (YY 0875-2013 Older version)
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Surgical instrument - Linear stapler and cartridge
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YY 0875-2023
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| YY 0875-2013 | English | 419 |
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Linear stapler and cartridge
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YY 0875-2013
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| Standard 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Count Estimation | 18,110 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2026-09-15 | | Older Standard (superseded by this standard) | YY 0875-2013; YY 0876-2013 | | Administrative Organization | National Surgical Instruments Standardization Technical Committee (SAC/TC 94) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and 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 instruments linear staplers and components
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
Preface
This 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 components
1 Scope
This 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 documents
The 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 Four
3 Terms and definitions
The 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.
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YY 0875-2013
Linear stapler and cartridge
ICS 11.040.30
C36
People's Republic of China pharmaceutical industry standards
Linear stapling 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, publication of this standard
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 Testing, Shanghai Medical Devices (Group)
Limited surgical instruments factory.
The Standard Participation. Jiangsu Medical Device Testing, Changzhou Xinghai triple Medical Devices Co., Ltd., Johnson & Johnson (China) Medical
Treatment equipment Limited.
The main drafters of this standard. Yuan Dongkun, Wengbing Hao, Liu Wei group.
Linear stapling and components
1 Scope
This standard specifies the linear stapler structure type and material requirements, test methods, marking, manual and packaging, transport and
Storage.
This standard applies to linear stapler (hereinafter referred to as stapling), stapler suitable for digestive tract reconstruction, organ resection surgery suture group
Woven organ stump and incision.
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
GB/T 230.1 metallic materials - Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K, N, T scale)
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. Evaluation of the risk management process and Test
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
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/T 0149-2006 stainless steel medical equipment corrosion test methods
YY/T 0171-2008 surgical instrument packaging, labeling and instructions for use
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 Using state
3.1 Components
Built staples, used only once.
3.2 Repetitive use stapler
Is the body after repeated sterilization for multiple surgeries, and aseptic packaging components used in conjunction.
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