Testing standard for anti deformation capability tooling

Testing standard for anti deformation capability tooling

Testing standard for anti deformation capability tooling

Anti deformation capability tooling----YY 0336-2020

Anti deformation capability toolingYY 0336-2020The standard is specifically designed to test the anti deformation ability of disposable sterile vaginal dilators, ensuring their structural stability and safety during clinical use.

The core requirements and design of this fixture are as follows:

UType fixture structure: The fixture adoptsUThe inner surface of the clamp should be basically aligned with the outer surfaces of the upper and lower blades of the expander to ensure uniform force distribution.

Fixture width: The width of the contact part of the fixture is(3±0.1)mmTo precisely control the area of action and avoid edge stress concentration.

Loading force range: The testing equipment needs to be able to apply0N–0.5NThe loading force and accuracy are controlled within ±0.1NSimulate the deformation under mild external forces in clinical practice.

Test speed: The loading speed should be stable at(90±10) mm/minEnsure that the testing process meets standard dynamic conditions and reflects real usage scenarios.

Measurement method: Before and after loading, use a universal or specialized measuring tool to measure the straight-line distance between the outer edges of the front ends of the upper and lower leaves of the expander, accurate to0.5mmCalculate the amount of deformation.

Environmental conditions: Testing should be conducted in22℃±2The test should be conducted in a ℃ environment, and the sample should be placed under these conditions4More than hours to eliminate the influence of temperature on material properties.

This fixture is used in conjunction with a mechanical testing machine and is a key auxiliary device for quality control in medical device manufacturing enterprises and testing institutions, ensuring that products comply with《YY 0336-2020》Industry standards.