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YY 0875-2023Surgical instruments - Linear staplers and cartridges (English PDF)

外科器械直线型吻合器及组件

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

September 5, 2023

Implementation date

September 15, 2026

Scope

YY 0875-2023 is the English-translated version of 外科器械直线型吻合器及组件.

YY 0875-2023 is the Chinese standard "Surgical instruments - Linear staplers and cartridges". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY 0875-2023

National Standard of the People's Republic of China

ICS: 11.060.20
Classification: C31
Replacing: YY 0875-2013; YY 0876-2013

Issued by: National Medical Products Administration

Foreword
3.5 of YY 0876-2013);
4.5.3);
4.9, 5.9, Appendix D and Appendix E of YY 0876-2013);

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

The device has been repeatedly sterilized and used in multiple surgeries and is used with sterile packaged components.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 16886 · ISO 13782

Similar standards

YY/T 0908|YY 0881|YY 0876|YY/T 0492

Editions of YY 0875

Edition	Title	Revision	Status
YY 0875-2023	Surgical instruments - Linear staplers and cartridges	current edition	Current
YY 0875-2013; YY 0876-2013	Surgical instruments - Linear staplers and cartridges	previous edition	In force until 2026-09-15

This page sells the current edition, YY 0875-2023. Earlier editions are listed for reference only.

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