ISO 11607-1 PDF

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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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Your basket is empty. We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands. Several techniques can be 1160-1. The strip must be cut perpendicular to the seal. A sample of each packaging seal must be collected and tested at its center see diagram below: Our experience as a designer, a manufacturer and an integrator of portable force measuring systems allows us to offer integrated products 11607-1 complete systems for assembly or manufacturing.

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. This part of ISO does not describe iao quality assurance system for control of all stages of manufacture.

Association for the Advancement of Medical Instrumentation

This standard offers the benefit of being applicable to a larger number of products than the previously described en Annex D test i. Small vise grip – N. This part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. 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: For each 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. Packaging which meets this standard ensures that the object it contains is sterilized and protected.

Peel tests on terminally sterilized medical packaging – ISO & 2

Requirements for materials, sterile barrier systems and packaging systems Status: This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically.

We achieved this goal thanks to a culture of innovation and a strict quality policy.

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It calls for a peel test on the sealed packaging: One of the specifications includes a validation test on sealed packaging. All these products feature the latest technologies and are designed for ease of use by industry technicians, laboratory or research. This standard is the primary guide for medical packaging validation. EN annex-D – Packaging for terminally sterilized medical devices.


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Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. BAT precision manual force test stand. However it does not specify a minimum force to be respected. Packaging designed to maintain sterility of medical devices needs to comply with several requirements.

BS EN ISO 11607-1:2017

Requirements and test methods. Seales pouches, porous reels, plastic film More video. These are a variety isl different peel tests: Take the smart route to manage medical device compliance.

The result report must include the following data: The primary method is a peel test on the 2 bonded materials.

We also have every possibility of calibration in force and torque in our laboratory. Each standard is 16107-1 due to sample size and the speed rate of separation but studies show that both methods produce similar results.

All products Calibration Operating manual. Here below are a few photos of seal quality peel test machines: A sample of each packaging seal must be collected and tested at its center see diagram below:.

The spec also allows for the use of various width samples: