《微生物屏障试验 din 58953-6_2010 test report》由会员分享，可在线阅读，更多相关《微生物屏障试验 din 58953-6_2010 test report（15页珍藏版）》请在金锄头文库上搜索。
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 Test3 1.1 Organization. 3 1.2 Occasion and Objective. 3 1.3 Time Schedule 3 1.4 Participants 4 2. Sample material 4 2.1 Sa
3、mple 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 45 2.2 Sample Preparation and Despatch
4、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 Results Sample F2
5、 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 Summary15 Interlaboratory Test Microbial Barrier of packaging material
6、s 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.generalsterilebarrier.org) P
7、ennygate 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:ISEGA Forschungs- u
8、. 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 medical devices - Part
9、 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 supply Part 6: Mic
10、robial 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 l
11、ose importance against validated methods in a revision of the ISO 11607-1 or may even not be considered at all. Within the framework of this interlaboratory test, data on the reproducibility of the results obtained by means of the analysis according to DIN 58953-6 shall be gathered. 1.3 Time Schedul
12、e September 2010:The Sterile Barrier Association queried ISEGA Forschungs- und Unter- suchungsgesellschaft about the technical support for the interlaboratory test. For the realization, the Verein zur Frderung der Forschung und Ausbildung fr Faserstoff- und Verpackungschemie e. V. (VFV) was won over
13、. November 2010: Preliminary announcement of the interlaboratory test / Seach for interested laboratories Interlaboratory Test Microbial Barrier of packaging materials for medical devices which are to be sterilized“ according to DIN 58953-6:2010 Test reportPage 4 / 15 January to December 2011: Searc
14、h for suitable sample material / Carrying out of numerous pre-trials on various materials January 2012:Renewed contact or search for additional interested laboratories, respectively February 2012: Sending out of registration forms / preparation of sample material March 2012: Registration deadline /
15、sample despatch May / June 2012: Results come in / statistical evaluation July 2012: Despatch of samples for the re-examination September 2012: Results of the re-examination come in / statistical evaluation November 2012: Results are sent to the participants December 2012/ January 2013: Compilation
16、of the test report 1.4 Participants Five different German laboratories participated in the interlaboratory test. In one laboratory, the analyses were performed by two testers working independently so that six valid results overall were received which can be taken into consideration in the evaluation. To ensure an anonymous evaluation of the results, each participant was assigned a laboratory number (laboratory 1 to laboratory 6) in random order, which was disclosed only to t
