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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However it does not specify a minimum force to be respected. This part of ISO does not describe a 111607-1 assurance system for control of all stages of manufacture. Packaging for terminally sterilized medical devices.

A sample of each packaging seal must iao collected and tested at its center see diagram below:. BAT precision manual force test stand. Find Similar Items This product falls into the following categories.

Who is this standard for? Requirements and test methods. This test involves cutting a 15mm wide strip on the package and using a motorized tensile testing machine to separate the two sealed materials. We offer measuring devices such as test benches, software, force and torque gauges, digital displays, manual and motorized test stands.

Sealable pouches 11067-1 reels of porous and plastic film construction.

Peel tests on terminally sterilized medical packaging – ISO & 2

We also have every possibility of calibration in force and torque in our laboratory. Overview Product Details What is this standard about?

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This part of ISO specifies the requirements and test methods for 11607–1, 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.

This standard offers the benefit of being applicable to a larger number of products than the 116607-1 described en Annex D test i. Several techniques can be applied. Especially, regarding the maximum load when the data is converted to equivalent width test strips. You may experience issues viewing this site in Internet Explorer 9, 10 or This standard is the primary guide for medical packaging validation.

BS EN ISO 11607-1:2017

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. The main requirements of this standard are stability, strength, integrity and dynamic performance testing. 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: The strip must be cut perpendicular to the seal.

All these products feature the latest technologies and are designed for ease of use kso industry technicians, laboratory or research. For each measurement case of force or torque, Andilog is creating an innovative and ergonomic solution. Small vise grip – N. All products Calibration Operating manual. Packaging which meets this standard ensures that the object it contains is sterilized and protected. 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.

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This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that isk manufactured 1107-1. Seales pouches, porous reels, plastic film More video.

Accept and continue 116071 more about the cookies we use and how to change your settings. 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.

Requirements for materials, sterile barrier systems and packaging systems. Package validation testing ensures that the packaging provides physical protection and maintains its sterility.

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