YY 0875-2023 in English
TO BE VALIDSurgical instrument--Linear stapler and cartridge
- Issued on:2023-09-05
- Implemented on:2026-09-15
- File Format:PDF
- Delivery:Via email within 1~3 business days
$262.00
| Standard No: | YY 0875-2023 |
| Document status: | TO BE VALID |
| Title in English: | Surgical instrument--Linear stapler and cartridge |
| Title in Chinese: | 外科器械 直线型吻合器及组件 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2023-09-05 |
| Implemented on: | 2026-09-15 |
| Superseding: |
YY 0875-2013 Linear stapler and cartridge
YY 0876-2013 Linear cutter stapler and cartridge |
| Professional Classification: | YY-Pharmaceutics |
| Related Topics: | straight line
Surgical Instruments Surgical Instruments line type new collimator Instruments and Instruments Combination equipment yy0875 foreign tissue surgery Stapler model surgery The difference between ligation device and stapler stapler international components yy0875-2023 yy 0875-2023 |
本文件规定了直线型吻合器的结构型式和材料、要求、试验方法、标签、说明书及包装。
本文件适用于直线型吻合器及组件。本文件不适用于血管专用吻合器、弧形吻合器及腔镜下使用的吻合器。
Introduction
Standard Evolution and Core Changes
| Comparison Dimensions | 2013 Edition of the Standard | 2023 Edition of the Standard |
|---|---|---|
| Scope of Application | Specialized vascular staplers are not explicitly excluded | New provisions that do not apply to vascular staplers and curved staplers |
| Material Requirements | Limited to titanium/titanium alloy materials | Proven safe materials are allowed (newly added tantalum materials) |
| Hardness Index | The hardness of the cutting knife is not specified | New hardness requirement for cutting knives ≥377HV0.2 |
| Chemical properties | No specific requirements | Added 5 new chemical property tests (heavy metals, reducing substances, etc.) |
Analysis of key technical requirements
1. Product classification system
The new version of the standard establishes a four-level classification framework:
- Basic function: cutting/non-cutting
- Usage: reusable/disposable
- Closing mechanism: fixed gap/adjustable gap
- Tool configuration: tool body with tool/component with tool
2. Core performance indicators
Requirements for stapler forming: A complete "B"-shaped structure must be formed after firing, and pass the EVA low-foam board simulation test (thickness = 1/2-2/3 of the staple height)
Cutting performance: For digestive tract reconstruction products, the staple line length must be ≥1.5 times the staple length (special designs require verification data)
Pressure resistance test: Leakage ≤10 drops within 15 seconds under a pressure of 3.6kPa, using fresh porcine intestine for simulation test
Material and manufacturing specifications
Requirements for key components
- Material for stapler: Titanium alloy (GB/T 13810) or tantalum material (ISO 13782), tensile strength ≥240MPa
- Surface treatment: Contact surface Ra≤1.6μm, reusable parts must pass boiling water corrosion resistance test (YY/T 0149)
- Hardness control: Anvil ≥35HRC, cutting knife needs to undergo three-point hardness test and take the average value
Added chemical performance test
| Test items | Indicator requirements | Test method |
|---|---|---|
| Total amount of heavy metals | ≤5μg/mL | GB/T 14233.1-2022 |
| Residual ethylene oxide | ≤10μg/g | Pharmacopoeia 2020 edition |
| Reducing substances | ΔV≤2.0mL | Potassium permanganate titration method |
Clinical application recommendations
Operation precautions
- Adjustable gap products need to ensure that the pointer is in the effective firing area
- After replacing the components, check that the staples are not exposed
- Verify the effectiveness of the safety device before using cutting products
Sterilization management
A sterilization validation plan should be established for reusable products, and the packaging of disposable products must have an opening indication function. Recommended:
- EO sterilization: residual detection + ventilation analysis
- Irradiation sterilization: material radiation resistance verification
Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.
We also recommend
-
YY/T 0063-1991 in English
Medical diagnostic X-ray tube assembly focus characteristics
1991-11-21 -
YY 0059-1991 in English
dental handpiece
1991-11-21 -
YY/T 1892-2024 in English
Break point cluster region - Abelson leukemia virus(BCR-ABL)fusiongene testing kit
2024-02-07 -
YY 0141-1993 in English
Test methods for suspended particles in clean rooms and clean areas of the pharmaceutical industry
1993-10-18 -
YY/T 0085.1-1992 in English
Pulse vacuum pressure steam sterilizer
1992-01-21 -
YY/T 1453-2016 in English
Tissue engineering medical device products--Methods for determination of type Ⅰ collagen
2016-07-29 -
YY/T 0106-1993 in English
Medical Diagnostic X-ray machine general technical conditions
1993-02-10 -
YY 0188-1993 in English
hip prosthesis
1993-07-19
