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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ISO Testing | Anecto
This website is best viewed with browser 116077-1 of up to Microsoft Internet Explorer 8 or Firefox 3. Click to learn more. Results cannot be differentiated by the speed or the sample width. Requirements for materials, sterile barrier systems and packaging systems Status: This part of ISO does not describe a quality assurance system for control of all stages of manufacture.
A sample of each packaging seal must be collected and tested at its center see diagram below: For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution. You may find similar items within these categories kso selecting from the choices below:. All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. Each standard is izo due to sample size and the speed rate of separation but studies show that 1607-1 methods produce similar results.
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: The result report must include the following data: This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. In the medical packaging industry, the isoo tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”.
Testing under ISO 11607 standard
Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. The primary method is a peel test on the 2 bonded materials. Learn more about the cookies we use and how to change your settings.
We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. It calls for a peel test on the sealed packaging: EN — Annexe D This test involves cutting a 15mm wide strip izo the package and using a motorized tensile testing machine to separate the two sealed materials. Seales pouches, porous reels, plastic film More video.
Packaging for terminally sterilized medical devices. This part of ISO specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical isi until the point of use. Who is this standard for?
A sample of each packaging seal must be collected and tested at its center see diagram below:. Here below are a few photos of seal quality peel test machines: Article isn’t rated yet.
Peel tests on terminally sterilized medical packaging – ISO & 2
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This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb. We achieved this goal thanks to a culture of innovation and a strict quality policy. One of the specifications includes a validation test on sealed packaging. This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
Your basket is empty. Take the smart route to manage medical device compliance. BAT precision manual force test stand.