Technical guidance for piercing test spikes and fixtures

Technical guidance for piercing test spikes and fixtures

Technical guidance for piercing test spikes and fixtures

Piercing test spikes and fixtures---YY/T0681.13-2014

Piercing the test needle and fixture isYY/T 0681.13-2014The key components used in the standard to determine the anti slow puncture performance of soft barrier films and composite films, evaluate the ability of medical device packaging to resist progressive penetration of sharp objects during transportation and storage by simulating the slow applied puncture force, and ensure the integrity of the sterile barrier.

According to the standard requirements, the core parameters and design specifications are as follows:

Spike geometry:

Adopting a hemispherical spike with a diameter of3.2mmThe surface is smooth and free of burrs, to simulate the slow compression of packaging film by instruments in clinical or logistics scenarios.

The material of the spike is usually stainless steel, which has sufficient hardness to avoid deformation during testing.

Fixture structure and dimensions:

The fixture is used to fix the specimen to ensure that it does not slip or wrinkle during the testing process.

The inner diameter of the upper and lower fixtures is generally76mm×76mm(Some devices are75mm×75mm）To form a standard testing area, the clamping force needs to be evenly distributed.

The fixture material is stainless steel, which has been polished to prevent corrosion, contamination, or damage to the sample.

Alignment accuracy requirements:

The spike must be precisely aligned with the center of the fixture, and the offset should not exceed0.5mmTo ensure that biaxial stress is uniformly applied to the surface of the specimen.

Test environment adaptability:

The entire set of tooling needs to be adapted to meet the requirementsYY/T 0681.13-2014Standard mechanical testing machines (such asTSTTesting machines, universal material testing machines, etc., support0–25 mm/minConstant loading rate control.

The equipment should have high-precision sensors that can record penetration power in real-time（N）Penetrating energy（J）And puncture depth（mm）Waiting for key data.

Sample state adjustment‌：

Before testing, the sample needs to be23±2℃、50%±5% RHAdjust at least in the environment40Hour by hour, ensure stable material performance and reduce environmental variable interference.

This fixture is widely used for quality testing in sterile medical device packaging, drug blister packaging, food high barrier film and other fields, and is the core testing component to ensure packaging safety.