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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Requirements for materials, sterile barrier systems and packaging systems.

Search all products by. Packaging for terminally sterilized medical devices. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.

Peel tests on terminally sterilized medical packaging – ISO & 2

This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. Requirements for materials, sterile barrier systems and packaging 116077-1 Status: Overview Product Details What is this standard about?

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 isoo sterility of terminally sterilized medical devices iwo the point of use. The faster, easier way to work with standards. Especially, regarding the maximum load when the data is converted to equivalent width test strips.

For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution. Several techniques can be applied. 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.

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The spec also allows for the use of various width samples: Usually ships in weeks. We achieved 1160-1 goal thanks to a culture of innovation and a strict quality policy. All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research.

This manual tester is easy to operate and designed to perform force tests in both compression and tension, up to N lb. The primary method is a peel test on the 2 bonded materials. BAT precision manual force test stand. Packaging designed to maintain sterility sio medical devices needs to comply with several requirements.

Article isn’t rated yet. You may experience issues viewing this site in Internet Explorer 9, 10 or The main requirements of this standard are stability, strength, integrity and dynamic performance testing.

Small vise grip – N. Please 1160-71 Chrome or Firefox or view our browser tips. One of the specifications includes a validation test on sealed packaging. 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 strip must be cut perpendicular to the seal. EN annex-D – Packaging for terminally sterilized medical devices. Learn more about the cookies we use and how 16107-1 change your settings.

Seales pouches, porous reels, plastic film More video. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control.

ISO Testing | Anecto

This standard is the primary guide for medical packaging validation. Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results.

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This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed 11607-1.

Who is this standard for? All products Calibration Operating manual. Package validation testing ensures that the packaging provides physical protection and maintains its sterility. This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that 11607-1 manufactured aseptically.

We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. Worldwide Standards We can source any standard from anywhere in the world. 11067-1 pouches and reels of porous and plastic film construction. In the medical packaging industry, the validation lso are specified by the ISO standard “Packaging for terminally sterilized medical devices”.

This part of ISO does not describe a quality assurance system for control of all stages of manufacture. Take the smart route to manage medical device compliance.

Testing under ISO 11607 standard

Your basket is empty. These are a variety of different peel tests: Results cannot be differentiated by the speed or the sample width. We use cookies kso make our website easier to use and to better understand your needs. Accept and continue Learn more about the cookies we use and how to change your settings. We also have 116007-1 possibility of calibration in force and torque in our laboratory. The result report must include the following data:

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