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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You may experience issues viewing this site in Internet Explorer 9, 10 or Please download Chrome or Firefox or view our browser tips. This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb.
BS EN ISO 11607-1:2017
This can be summarized by measuring the force required to separate the two sealed materials, which is equivalent to the opening force of the packaging. Find Similar Items This product falls into the following categories. Article isn’t rated yet. Seales pouches, ixo reels, plastic film More video. Packaging designed to maintain sterility ixo medical devices needs to comply with several requirements. Requirements for materials, sterile barrier systems and packaging systems Status: However it does not specify a minimum force to be respected.
This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Especially, regarding the maximum load when the data is converted to equivalent width test strips.
Peel tests on terminally sterilized medical packaging – ISO & 2
We also have every possibility of calibration in force and torque in our laboratory. In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”. The result report must include the following data: BAT precision manual force test stand.
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. Sealable ixo and reels of porous and plastic film construction.
The force should be at least equal to 1. Requirements for materials, sterile barrier systems and packaging systems.
Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results. A sample of 1107-1 packaging seal must be collected and tested at its center see diagram below: These are a variety of different peel tests: 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: Who is this standard for?
This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials.
All products Calibration Operating manual. Click to learn more.
Testing under ISO 11607 standard
We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. The primary method is a peel test on the 2 bonded materials. Usually ships in weeks. It calls for io peel test on the sealed packaging: Several techniques can be applied.