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.

Author: Vudojin Tygoramar
Country: Belarus
Language: English (Spanish)
Genre: Art
Published (Last): 17 January 2015
Pages: 70
PDF File Size: 3.55 Mb
ePub File Size: 3.44 Mb
ISBN: 669-8-20040-628-5
Downloads: 59878
Price: Free* [*Free Regsitration Required]
Uploader: Gromuro

In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”. Overview Product Details What is this standard about? Here below are a few photos of seal quality peel test machines: Packaging which meets this standard ensures that the object it contains is sterilized and protected. Learn more about the cookies we use and how to change your settings.

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 systems. Requirements for materials, sterile barrier systems and packaging systems Status: BAT precision manual force test stand. Packaging for terminally sterilized medical devices. The result report must include the following data: 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.


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 main requirements of this standard are stability, strength, integrity and dynamic performance testing.

It calls for a peel test on the sealed packaging: This part of ISO does not describe a 11607-1 assurance system for control of all stages of manufacture.

BS EN ISO 11607-1:2017

The faster, easier way to work with standards. Take the smart route to manage medical device compliance. One of the specifications includes a validation test on sealed packaging.

Article isn’t rated yet. All products Calibration Operating manual.

We use cookies to make our website easier to use and to better understand your needs. We offer measuring devices such as test iiso, software, force and torque gauges, digital displays, manual and motorized test stands.

Several techniques can be applied. 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.

Peel tests on terminally sterilized medical packaging – ISO & 2

Sealable pouches and reels of porous and plastic film construction. This standard offers the benefit of being applicable to a larger number of products izo the previously described en Annex D test i.


Package validation testing ensures that the packaging provides physical protection and maintains its sterility. Especially, regarding the maximum load when the data is iwo to equivalent width test strips.

The force should be at least equal to 1.

ISO Testing | Anecto

Please download Chrome or Firefox or view our browser tips. You may experience issues viewing this site in Internet Explorer 9, 10 or Click to learn more. 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.

Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control.

Search all products by. This standard is the primary guide for medical packaging validation. However it does not specify a minimum force to be respected. Worldwide Standards We can source isso standard from anywhere in the world.

EN annex-D – Packaging for terminally sterilized medical devices. Small vise grip – N. The strip must be cut perpendicular to the seal.