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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A sample of each packaging seal must be collected and tested at its center see diagram below: This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

BS EN ISO 11607-1:2017

BAT precision manual force test stand. The strip must be cut perpendicular to the seal. Click to learn more. Your basket is empty. The main requirements of this standard are stability, strength, integrity and dynamic performance testing. The force should be at least equal to 1.

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. It calls for a peel test on the sealed packaging: Capacity up to 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs.

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

All these products feature 11607- latest technologies and are designed for ease of use by industry technicians, laboratory or research. Usually ships in weeks. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.


Take the smart route to manage medical device compliance. Requirements for materials, 11607- barrier systems and packaging systems Status: Sealable pouches and reels of porous and plastic film construction.

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Peel tests on terminally sterilized medical packaging – ISO & 2

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: Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. You may find similar items 16107-1 these categories by selecting from the choices below:. Requirements and test methods. This test involves cutting a 15mm wide strip on the package and using a motorized tensile iiso machine to separate the two sealed materials.

Please download Chrome or Firefox or view our browser tips. We use cookies to make our website easier to use and to better understand your needs. This part of ISO does not describe a quality assurance system for control of all stages of manufacture. isk

Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results. Worldwide Standards We can source any standard from anywhere in the world.

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The faster, easier way to work with standards. Who is this standard for? Especially, regarding the maximum load when the data is converted to equivalent width test strips.

These are a variety of different peel tests: Package validation testing ensures that the packaging provides physical protection and maintains its sterility.


Small vise grip – N. 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.

Overview Product Details What is this standard about? Seales pouches, porous reels, plastic film More video. Packaging which meets this standard ensures that the object it contains is sterilized and protected. This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i.

However it does not specify a minimum force to be respected.

ISO Testing | Anecto

Here below are a few photos of seal quality peel test machines: This part of ISO specifies the requirements and test methods 11607-11 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. Results cannot be differentiated by the speed or the sample width. In the medical packaging industry, the 11067-1 tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”.

This standard is the primary guide for medical packaging validation. Packaging designed to maintain sterility of medical devices needs to comply with several requirements. One of the specifications includes a validation test on sealed packaging.

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