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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The main requirements of this standard are stability, strength, integrity and dynamic performance testing. Please download Chrome or Firefox or view our browser tips. For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution. 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.

One of the specifications includes a validation test on sealed packaging. Search all products by. Requirements and test methods.

Peel tests on terminally sterilized medical packaging – ISO & 2

Packaging designed to maintain sterility of medical devices needs to comply with several requirements. Accept and continue Learn more about the cookies we use and how to change your settings. Overview Product Details What is this standard about?

Packaging which meets this standard ensures that the object it contains is sterilized and protected. Requirements for materials, sterile barrier systems and packaging systems. Sealable 116607-1 and reels of porous and plastic film construction.

This part of ISO specifies the requirements and io 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.

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Small vise grip – N. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Take the smart route to manage medical device compliance.

We also have every possibility of calibration in force and torque in our laboratory. Package validation testing ensures that the packaging provides physical protection and maintains its sterility.

Usually ships in weeks. Who is this standard for? Here below are a few photos of seal quality peel test machines: The strip must be cut perpendicular to the seal.

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Association for the Advancement of Medical Instrumentation

A sample of each packaging seal must be collected and tested at its center see diagram below:. 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: You may find similar 11607-11 within these categories by selecting from the choices below:. A sample of each packaging seal must be collected and tested at its center see diagram below: We use cookies to make our website easier to use and to better understand your needs.

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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.

The spec also allows for the use of various width samples: BAT precision manual force test stand. In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”. This standard is the primary guide for medical packaging validation. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. EN annex-D – Packaging for terminally sterilized medical devices.

It calls for a peel test on the sealed packaging: This part of ISO does not describe a quality assurance system for control of all stages of manufacture. We achieved this goal thanks to a culture of innovation and a strict quality policy. All products Calibration Operating manual. Packaging for terminally sterilized medical devices. Several techniques can be applied.

ISO Testing | Anecto

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 result report oso include the following data: Worldwide Standards We can source any standard from anywhere in the world. The force should be at least equal to 1.

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