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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You jso experience issues viewing this site in Internet Explorer 9, 10 or 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. The result report must include the following data: Results cannot be differentiated by the speed or the sample width.

A sample of each packaging seal must be collected and tested at its center see diagram below: Accept and continue Learn more about the cookies we use and how to change your settings. Find Similar Items This product falls into the following categories. Requirements for materials, sterile barrier systems and is systems Status: Especially, regarding the maximum load when the data is converted to equivalent width test strips.

Small sio grip – N. This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. The main requirements of this standard are stability, strength, integrity and dynamic performance testing. All isso products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research.


Here below are a few photos of seal quality peel test machines: 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.

Peel tests on terminally sterilized medical packaging – ISO & 2

Who is this standard for? We use cookies to make our website easier to use and to better understand your needs. EN annex-D – Packaging for terminally sterilized medical devices.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This standard is the primary guide for medical packaging validation. BAT precision manual force test stand. However it does not specify a minimum force to be respected. The spec also allows for the use of various width samples: The force should be at least equal to 1. Overview Product Details What is this standard about? Sealable pouches and reels of porous and plastic film construction.

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Association for the Advancement of Medical Instrumentation

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.


Packaging which meets this standard ensures that the object it contains is sterilized and protected. Capacity up to 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs.

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This can be summarized by measuring the force required to separate the two sealed ido, which is equivalent to the opening force of the 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. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. This part of ISO does not cover all requirements for sterile barrier systems and packaging systems 11067-1 medical devices that are manufactured aseptically.

Take the smart route to manage medical device compliance. You may find similar items within these categories by selecting from the choices below:. One of the specifications includes a validation test on sealed packaging.