The puncture test needle and fixture have stable performance

The puncture test needle and fixture have stable performanceThe puncture test needle and fixture have stable performance

Piercing test needle and fixture - YY/T0681.13-2014

The puncture test needle and fixture are key components used in YY/T0681.13-2014 standard to determine the resistance of soft barrier films and composite films to slow puncture. By simulating the slowly applied puncture force, the ability of medical device packaging to resist the gradual penetration of sharp objects during transportation and storage is evaluated, ensuring 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 of 3.2mm and a smooth surface without burrs, to simulate the slow compression scenario of the instrument end on the packaging film in clinical or logistics settings.

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 generally 76mm × 76mm (some equipment is 75mm × 75mm), forming a standard testing area, and 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 piercing head must be precisely aligned with the center of the fixture, with a deviation not exceeding 0.5mm, to ensure that biaxial stress is evenly applied to the surface of the specimen.

Test environment adaptability:

The entire set of tooling needs to be compatible with mechanical testing machines that comply with YY/T0681.13-2014 standards (such as TST testing machines, universal material testing machines, etc.), supporting constant loading rate control of 0-25mm/min.

The equipment should have high-precision sensors that can record key data such as penetration power (N), penetration energy (J), and puncture depth (mm) in real time.

Sample state adjustment:

Before testing, the sample needs to be conditioned in an environment of 23 ± 2 ℃ and 50% ± 5% RH for at least 40 hours to ensure stable material properties 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.

Piercing test needle and fixture meet the standard. Piercing test needle and fixture meet the standard

Piercing test needle and fixture - YY/T0681.13-2014

The puncture test needle and fixture are key components used in YY/T0681.13-2014 standard to determine the resistance of soft barrier films and composite films to slow puncture. By simulating the slowly applied puncture force, the ability of medical device packaging to resist the gradual penetration of sharp objects during transportation and storage is evaluated, ensuring 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 of 3.2mm and a smooth surface without burrs, to simulate the slow compression scenario of the instrument end on the packaging film in clinical or logistics settings.

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 generally 76mm × 76mm (some equipment is 75mm × 75mm), forming a standard testing area, and 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 piercing head must be precisely aligned with the center of the fixture, with a deviation not exceeding 0.5mm, to ensure that biaxial stress is evenly applied to the surface of the specimen.

Test environment adaptability:

The entire set of tooling needs to be compatible with mechanical testing machines that comply with YY/T0681.13-2014 standards (such as TST testing machines, universal material testing machines, etc.), supporting constant loading rate control of 0-25mm/min.

The equipment should have high-precision sensors that can record key data such as penetration power (N), penetration energy (J), and puncture depth (mm) in real time.

Sample state adjustment:

Before testing, the sample needs to be conditioned in an environment of 23 ± 2 ℃ and 50% ± 5% RH for at least 40 hours to ensure stable material properties 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.