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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Packaging which lso this standard ensures that the object it contains is sterilized and protected. Requirements for materials, sterile barrier systems and packaging systems. Sealable pouches and reels of porous and plastic film construction. The faster, easier way to work with standards. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. Packaging for terminally sterilized medical devices. Take the smart route to manage medical device compliance.

Usually ships in weeks. For lso measurement case of force or torque, Andilog is creating an innovative and ergonomic solution.

We use cookies to make our website easier to use and to better understand your needs. Your basket is empty. Capacity up to 5 N 1 lb 1107-1 force measuring system Color Touch screen with display force vs.

Requirements and test methods. 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.

BAT precision manual force test stand.

ISO Testing | Anecto

Several techniques can be applied. This part of ISO does not describe a quality assurance system for control of all stages of manufacture. All products Calibration Operating manual.


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: In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”.

We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. These are a variety of different peel tests: Especially, regarding the maximum load when the data is iao to equivalent width test strips. Worldwide Standards We can source any standard from anywhere in the world. Find Similar Items This product falls into the following categories.

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This standard offers the ixo of being applicable to a larger number of products than the previously described en Annex D test i. Here below are a few photos of seal quality peel test machines: Search all products by.

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:. It calls for a peel test on the sealed packaging: We achieved this goal thanks to a culture of innovation and a strict quality policy. 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 website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Article isn’t rated yet. 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. Package validation testing ensures that the packaging provides physical protection and maintains its sterility. Seales pouches, porous reels, plastic film More video. Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results.


The strip must be cut perpendicular to the seal. Packaging designed to maintain sterility of medical devices needs to comply with several requirements. The primary method is a peel test on the 2 bonded materials. 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: Overview Product Details What is this standard about?

Association for the Advancement of Medical Instrumentation

The main requirements of this standard are stability, strength, integrity and dynamic performance testing. EN annex-D – Packaging for terminally sterilized medical devices. Learn more about the cookies we use and how to change your settings.

This standard is the primary guide for medical packaging validation. All these products feature the latest technologies and are 111607-1 for ease of use by industry technicians, laboratory or research. Accept and continue Learn more about the cookies we use and how to change your settings.