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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All products Calibration Operating manual.

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 use cookies to make our website easier to use and to better understand your needs. Your basket is empty. Seales pouches, porous reels, plastic film More video. The force should be at least equal to 1.

Usually ships in ios. Requirements and test methods. Overview Product Details What is this standard about? Requirements for materials, sterile barrier systems and packaging systems Status: This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically.

You may find similar items within these categories by selecting from the choices below:. Search all products by. One of the specifications includes a validation test on sealed packaging. Please download Chrome or Firefox or view our browser tips.

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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: BAT precision manual force test stand. It calls for a peel test on the sealed packaging: All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. This standard offers the benefit of being applicable 11670-1 a larger number of products than the previously described en Annex D test i. These are a variety of different peel tests: The faster, easier way to work with standards.

Capacity up to 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs. This standard is the primary guide for medical packaging validation. Results cannot be differentiated by the speed or the sample width. We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. This part of ISO does not izo a quality assurance system for control of all stages of manufacture.

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Testing under ISO 11607 standard

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. The primary method is a peel test on the 2 bonded materials.

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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Worldwide Standards We can source any standard from anywhere in the world. Several techniques can be applied.

This can be summarized by measuring the force required to separate the two sealed materials, 116607-1 is 11067-1 to the opening force of the packaging. For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution.

This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials. Learn more about the cookies we use and how to change your settings.

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Click to learn more. We achieved this goal thanks to a culture of innovation and a strict quality policy. Package validation testing ensures that the packaging provides physical protection and maintains its sterility.

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