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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The faster, easier way to work with standards. Results cannot be differentiated by the speed or the sample width.
We offer measuring devices such as test benches, software, force and torque 1160-1, digital displays, manual and motorized 111607-1 stands.
Requirements and test methods. However it does not specify a minimum force to be respected. Click to learn more. Capacity up to N lb mm travel Handwheel operated Smooth precision motion Fine positional control. EN annex-D – Packaging for terminally sterilized medical devices. One of the specifications includes a validation test on sealed packaging. Take the smart route to manage medical device compliance.
All these products feature the latest technologies and are designed for ease of use iiso industry technicians, laboratory or research. Usually ships in weeks. This part of ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically.
Testing under ISO 11607 standard
Each standard is different due to sample size and the speed rate of separation but studies show that both methods produce similar results. This manual tester is easy to operate and designed to perform 11607–1 tests in both compression and tension, up to N lb. The spec also allows for the use of various width samples: Small vise grip – N. All products Calibration Operating manual.
Sealable pouches and reels of porous and plastic film construction. The main requirements of this standard are stability, strength, integrity and dynamic performance testing.
Requirements for materials, sterile barrier systems and packaging systems Status: Here below are a few photos of seal quality peel test machines: 11670-1 part of ISO is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
Association for the Advancement of Medical Instrumentation
A sample of each packaging seal must be collected and jso at its center 111607-1 diagram below: This standard is the primary guide for medical packaging validation. Seales pouches, porous reels, plastic film More video. In the medical packaging industry, the validation tests are specified by the ISO standard “Packaging for terminally sterilized medical devices”.
The result report must include the following data: A sample of each packaging seal must be collected and tested at its center see diagram below:.
These are a variety of different peel tests: It calls for a peel test on the sealed packaging: Your basket is empty. Find Similar Items This product falls into the following categories.
Peel tests on terminally sterilized medical packaging – ISO & 2
The strip must be cut perpendicular to the seal. You may find similar items within these categories by selecting from the choices below:.
Packaging designed to maintain sterility of medical devices needs to comply with several requirements. Please download Chrome or Firefox or view our browser tips.
This website is best viewed with browser version of isl to Microsoft Internet Explorer 8 or Firefox 3. BAT precision manual force test stand. The primary method is a peel test on the 2 bonded materials.
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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