I.S. EN ISO Standards. Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and. STANDARD. ISO. First edition. Packaging for terminally sterilized medical devices — ISO’s member body in the country of the requester . AMENDEMENT 1. STANDARD. ISO. First edition. Reference number. ISO /Amd(E). AMENDMENT 1.
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Packaging designed to maintain sterility of medical devices needs to comply with several requirements. Package validation testing ensures that the packaging provides physical protection and maintains its sterility. One of the specifications includes a validation test on sealed packaging. Several techniques can be applied. The primary method is a peel test on the 2 bonded materials. This can be summarized by measuring the 1160-1 required to separate the two sealed materials, which is equivalent to the opening force of the packaging.
In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”. This standard is the primary guide for medical packaging validation. Packaging which meets this standard ensures that the object it contains is sterilized and protected. The main requirements of this standard are stability, strength, integrity and dynamic ios testing.
It calls for a peel test on the sealed packaging: This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials. The strip must be cut perpendicular to the seal. A sample of each packaging seal must be collected and tested at its center see diagram below:.
BS EN ISO 11607-1:2017
The force should be at least equal to 1. This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. However it does not specify a minimum force to be respected. Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results.
Especially, regarding the maximum load when the data is converted to equivalent width test strips. Results cannot be differentiated by the speed or the sample width. This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb.
Association for the Advancement of Medical Instrumentation
We achieved this goal thanks to a culture of innovation and a strict quality policy. For each measurement case of force or torque, Andilog is creating an innovative 116071- ergonomic solution.
We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands.
16107-1 also have every possibility of calibration in force and torque in our laboratory. Our experience as a designer, a manufacturer and an integrator of portable force measuring systems allows us to offer integrated products into complete systems for assembly or manufacturing.
All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. EN annex-D – Packaging for terminally sterilized medical devices.
Sealable pouches and reels of porous and plastic film construction. Requirements and test methods. EN — Annexe D This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials.
Peel tests on terminally sterilized medical packaging – ISO & 2
A sample of each packaging seal must be collected and tested at its center see diagram below: The result report must include the following data: The date A reference of the tested product The maximum recorded strength in N for 15mm width Reference of the tensile tester used The acquisition rate of the tensile tester The curve of the load A description of the technique used: These are a oso of different peel tests: The spec also allows for the use of various width samples: Here below are a few photos of seal quality peel test machines: Seales pouches, porous reels, plastic film More video.
Article isn’t rated yet. Capacity up to 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs. Usually ships in weeks. BAT precision manual force test stand.
Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. Small vise grip – N. All products Calibration Operating manual.