GB/T 10160-1995 in English
ABOLISHEDTest methods of locking force and opening force for medical use forceps
- Issued on:1995-06-02
- Implemented on:1995-01-02
- File Format:PDF
- Delivery:Via email within 1~3 business days
$175.00
《GB/T 10160-1995医用钳锁合力、脱开力测定方法》由TC94（全国外科器械标准化技术委员会）归口，主管部门为国家药品监督管理局。
本标准规定了医用钳锁合力、脱开力测定方法和仪器要求。本标准适用于指圈型带锁牙的医用钳类产品锁合力和脱开力的测定。
Introduction
Interpretation of the core content of the standard
This standard specifies the test methods for two key mechanical parameters: locking force and disengagement force for finger ring type medical forceps with locking teeth structure. Among them:
| Parameter type | Physical definition | Test objective | Clinical significance |
|---|---|---|---|
| Locking force | The minimum force required to close the forceps locking teeth | Ensure the normal closing function of the instrument | Affect the smoothness of surgical operation |
| Disengagement force | The minimum force required to separate the closed locking teeth | Verify the reliability of instrument locking | Related to the risk of accidental opening during surgery |
Detailed explanation of instrument technical requirements
Chapter 3 of the standard puts forward 7 key requirements for testing equipment:
- Ambient temperature is controlled within the range of 5-35℃
- Radial runout of the fixture spindle is ≤0.01mm
- Test speed is constant at 60±3mm/min
- Indication error does not exceed ±1.5%FS
- Fourth-grade standard weights are required for annual inspection
Typical case: When an enterprise used a universal material testing machine to transform the test system, it did not consider the radial runout requirements of the fixture, resulting in the discreteness of the test data exceeding the standard allowable range. This was later solved by adding high-precision bearings.
Key points for implementing the test method
Specifications for locking force test
As shown in Figure 1 of the standard:
- The finger ring fixation must ensure that the force direction passes through the middle
- The jaws must be thoroughly cleaned with alcohol before testing
- The arithmetic average of the three test peaks
Differences in disengagement force test
Different from locking force test:
- Positioning marks must be made in advance at the force-bearing part
- The center line of the jaw body and the top core blade must be perpendicular
- The initial spacing requirement is ≥5mm
Analysis of standard technology evolution
Main improvements when this standard replaces the 1988 version of GB 10160~10161:
| Technical elements | 1988 Edition | 1995 Edition |
|---|---|---|
| Test speed | Not specified | 60±3mm/min |
| Error control | Only require total range error | Add indication variation error≤1% |
| Instrument calibration | No specified cycle | Clear annual inspection requirements |
Enterprise implementation suggestions
Key points of quality control
- Establish a test equipment inspection system, focusing on monitoring the radial runout of the fixture spindle
- The test environment needs to be equipped with a temperature and humidity monitoring device
- A traceability record should be established for standard weights
Solutions to common problems
Problem:Abnormal fluctuations in test data
Analysis:Possible causes: ①Incomplete cleaning of the jaws ②Loose fixture ③Excessive ambient temperature
Countermeasures:Implement a pre-test confirmation checklist (including cleanliness inspection, fixture preload test, etc.)
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