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1、Interlaboratory Test Microbial barrier testing of packaging materials for medical devices which are to be sterilized“ according to DIN 58953-6:2010 Test report January 2013 Author: Daniel Zahn ISEGA Forschungs- und Untersuchungsgesellschaft mbH Interlaboratory Test Microbial Barrier of packaging mat
2、erials for medical devices which are to be sterilized“ according to DIN 58953-6:2010 Test reportPage 2 / 15 Table of contents Seite 1. General information on the Interlaboratory Test.3 1.1 Organization. 3 1.2 Occasion and Objective. 3 1.3 Time Schedule. 3 1.4 Participants. 4 2. Sample material. 4 2.
3、1 Sample Description and Execution of the Test.4 2.1.1 Materials for the Analysis of the Germ Proofness under Humidity according to DIN 58953-6, section 3. 5 2.1.2 Materials for the Analysis of the Germ Proofness with Air Permeance according to DIN 58953-6, section 4.5 2.2 Sample Preparation and Des
4、patch. 5 2.3 Additional Sample and Re-examination. 6 3. Results. 6 3.1 Preliminary Remark. 6 3.2 Note on the Record of Test Results. 6 3.3 Comment on the Statistical Evaluation. 6 3.4 Outlier tests. 7 3.5 Record of Test Results. 7 3.5.1 Record of Test Results Sample F1. 8 3.5.2 Record of Test Result
5、s Sample F2. 9 3.5.3 Record of Test Results Sample F3. 10 3.5.4 Record of Test Results Sample L1. 11 3.5.5 Record of Test Results Sample L2. 12 3.5.6 Record of Test Results Sample L3. 13 3.5.7 Record of Test Results Sample L4. 14 4. Overview and Summary.15 Interlaboratory Test Microbial Barrier of p
6、ackaging materials for medical devices which are to be sterilized“ according to DIN 58953-6:2010 Test reportPage 3 / 15 1. General Information on the Interlaboratory Test 1.1 Organization Organizer of the Interlaboratory Test: Sterile Barrier Association (SBA) Mr. David Harding (director.generalster
7、ilebarrier.org) Pennygate House, St Weonards Herfordshire HR2 8PT / Great Britain Realization of the Interlaboratory Test:Verein zur Frderung der Forschung und Ausbildung fr Faserstoff- und Verpackungschemie e. V. (VFV) vfvisega.de Postfach 10 11 09 63707 Aschaffenburg / Germany Technical support:IS
8、EGA Forschungs- u. Untersuchungsgesellschaft mbH Dr. Julia Riedlinger / Mr. Daniel Zahn (infoisega.de) Zeppelinstrae 3 5 63741 Aschaffenburg / Germany 1.2 Occasion and Objective In order to demonstrate compliance with the requirements of the ISO 11607-1:2006 Packaging for terminally sterilized medic
9、al devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems“ validated test methods are to be preferably utilized. For the confirmation of the microbial barrier properties of porous materials demanded in the ISO 11607-1, the DIN 58953-6:2010 Sterilization Sterile s
10、upply Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized“ represents a conclusive method which can be performed without the need for extensive equipment. However, since momentarily no validation data on DIN 58953-6 is at hand concerns emerged that the method may lose importance against validated methods in a revision of the ISO 11607-1 or
