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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Please download Chrome or Firefox or view our browser tips. The primary method is a peel test on the 2 bonded materials. However it does not specify a minimum force to be respected. Packaging designed to maintain sterility of medical devices needs to comply with several requirements. We use cookies to make our website easier to use and to better understand your needs. One of the specifications includes a validation test on sealed packaging. Each standard is different due to sample size and the speed rate of separation but studies show that both methods jso similar results.

All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. Requirements and test methods. This standard is the primary guide for medical packaging validation.

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 spec also allows for the use of various width samples: 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 isoo used: Worldwide Standards We can source any standard from anywhere in the world.


Overview Product Details What is this standard about? Requirements for materials, sterile barrier systems and packaging systems Status: Packaging for terminally sterilized 1107-1 devices. This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb. All products Calibration Operating manual. The result report must include the following data: We also have every possibility of calibration in force and torque in our laboratory.

Association for the Advancement of Medical Instrumentation

Find Similar Items This product 11670-1 into the following categories. BAT precision manual force test stand. Ios up to 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs. Learn more about the cookies we use and how to change your settings. For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution.

Results cannot be differentiated by the speed or the sample width. You may 116071 similar items within these categories by selecting from the choices below:. 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.

Several techniques can be applied. Seales pouches, porous reels, plastic film More video.

Peel tests on terminally sterilized medical packaging – ISO & 2

This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials. This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

Here below are a few photos of seal quality peel test machines: Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control.


It calls for a peel test on the sealed packaging: Take the smart route to manage medical device compliance.

The main requirements of this standard are stability, strength, integrity and dynamic performance testing.

Click to learn more. These are a variety of different peel tests: You may experience issues viewing this site in Internet Explorer 9, 10 or Search all products by. Especially, regarding the maximum load when the data is converted to equivalent width test strips.

Package validation testing ensures that the packaging provides physical protection and maintains its sterility. The force should be at least equal to 1.

Requirements for materials, sterile barrier systems and packaging systems.

A sample of each packaging seal must be collected and tested at its center see diagram below:. Usually ships in weeks.

Testing under ISO 11607 standard

Accept and continue Learn more about the cookies we use and how to change your settings. We achieved this goal thanks to a culture of innovation and a strict quality policy.

Sealable pouches and reels of porous and plastic film construction. 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. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The strip must be cut perpendicular to the seal. This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i.

Who is this standard for?