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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This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems kso sterilized. Sealable pouches and reels of porous and plastic film construction. This part of ISO does not describe a quality assurance system for control of all stages of manufacture. Requirements for materials, sterile barrier systems and packaging systems.
BS EN ISO 11607-1:2017
However it does not oso a minimum force to be respected. Your basket is empty. You may experience issues viewing this site in Internet Explorer 9, 10 or Who is this standard for? Click to learn more. These are a variety of different peel tests: 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.
The primary method is a peel test on the 2 bonded materials. A sample of each packaging seal must be collected and tested at its center see diagram below: You may find similar items within these categories by selecting from the choices below:.
The spec also allows for the use of various width samples: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Package validation testing ensures that the packaging provides physical 111607-1 and maintains its sterility. Requirements for materials, sterile barrier systems and packaging systems Status: Results cannot be differentiated by the speed or the isl width. Capacity up 1167-1 5 N 1 lb Autonomous force measuring system Color Touch screen with display force vs.
For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution.
A sample of each packaging seal must be collected and tested at its center see diagram below:. 11607-1 the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”.
Article isn’t rated yet. Packaging which meets this standard ensures that the object it contains is sterilized and protected. The faster, easier way to work with standards.
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.
This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. We also have every possibility of calibration in force and torque in our laboratory. EN — Annexe D This test involves cutting a 15mm wide strip on 11607- package and using a motorized tensile testing machine to separate the two sealed materials. Worldwide Standards We can source any standard from anywhere in the world.
Here below are a few photos of seal quality peel test machines: One of the specifications includes a validation test on sealed packaging.
This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb. All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. We achieved this goal thanks to a culture of innovation and a strict quality policy. This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically.
Peel tests on terminally sterilized medical packaging – ISO & 2
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This standard is the primary guide for medical packaging validation. The force should be at lso equal to 1. The main requirements of this standard are stability, strength, integrity and dynamic performance testing. Learn more about the cookies we use and how to change your settings. Accept and continue Learn more about the cookies we use and how to change your settings.
ISO Testing | Anecto
116071 for terminally sterilized medical devices. All products Calibration Operating manual. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. Take the smart route to manage medical device compliance.
Requirements and test methods. 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?
Especially, regarding the maximum load when the data is converted to equivalent width test strips. This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials.
BAT precision manual force test stand. The result report must include the following data: