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ISO 11607-1 PDF

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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This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. You may experience issues viewing this site in Internet Explorer 9, 10 or 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 devices until the point of use.

We achieved this goal thanks to a culture of innovation and a strict quality policy. Find Similar Items This product falls into the following categories. The spec also allows for the use of various width samples: Click to learn more. Search all products by.

Association for the Advancement of Medical Instrumentation

Overview Product Details What is this standard about? This standard is the primary guide for medical packaging validation.

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Package validation testing ensures that the packaging provides physical protection and maintains its sterility. Capacity up to 5 N 1 lb Autonomous iwo measuring system Color Touch screen with display force vs. You may find similar items within these categories by selecting from the choices below:. The faster, easier way to work with standards.

Peel tests on terminally sterilized medical packaging – ISO & 2

Take the smart route to manage medical device compliance. We use cookies to make our website easier to use and to better understand your needs. Ieo for materials, sterile 1160-1 systems and packaging systems Status: Worldwide Standards We can source any standard from anywhere in the world. Here below are a few photos of seal quality peel test machines: One of the specifications includes a validation test on sealed packaging. The strip must be cut perpendicular to the seal. Packaging which meets this standard ensures that the object it contains is sterilized and protected.

This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed 11670-1 sterile barrier systems and sterilized.

Requirements and test methods. Sealable pouches and reels of porous and plastic film construction. Accept and continue Learn more about the cookies we use and how to change your settings. This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb.

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A sample of each packaging seal must be collected and tested at its center see diagram below:. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control.

BS EN ISO 11607-1:2017

Requirements for materials, sterile barrier systems and packaging systems. These are a variety of different peel tests: Results cannot be 116077-1 by the speed or the sample width.

Especially, regarding the maximum load when the data is converted to equivalent width test strips. A sample of each packaging seal must be collected and tested at its center see diagram below: Several techniques can be applied.

This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials. We offer measuring devices such as test 1160-1, software, force and torque gauges, digital displays, manual and motorized test stands. BAT precision manual force test stand. The result report must include the following data: 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.