Sealing technology manual for the process industry

AREA OF APPLICATION TESTING INSTITUTE TESTING ON VALIDITY PERIOD TESTING CRITERIA Germany DVGW-certified laboratories Material 5 years Microbiological examination Germany DVGW-certified laboratories Material and product 5 years • BfRpositivelist • Chlorine loss • TOC (total organic carbon) level • Migration tests France CRECEP – Paris LHRSP – Nancy IP – Lille Material and product 5 years • Positive list • Material composition • Cytotoxicity • TOC level Great Britain WRAS-certified laboratories Material and product 5 years • Material composition • Manufacture • Cytotoxicity • Migration tests Austria (also accepts the KTW test) ÖVGW-certified laboratories Material and product 5 years • Positive list • Material composition • Chlorine loss • TOC level • Migration tests Netherlands KIWA Material and product 5 years • Material composition • Manufacture • Toxicity tests • Migration tests • Microbiological examination Denmark (also accepts the KTW test) Certified laboratories Material and product 5 years • Positive list • Material composition • Manufacture • TOC level • Migration tests USA NSF-certified laboratories Material and product 5 years with annual audit • Material composition • Examination of the components • Toxicity tests • Microbiological examination Australia AWQC-certified laboratories Material and product 5 years • Material composition • Manufacture • Toxicity tests • Migration tests Europe Every accredited testing laboratory Material unlimited • BfR 21. recommendation cat. 4 • ADI free Europe Every accredited testing laboratory Material unlimited • Determination of OML and SML values in different media and temperatures Germany Every accredited testing laboratory Material unlimited • BfR positive list • Migration tests (subdivided into cate- gories, depending on the contact time) Germany Every accredited testing laboratory Material unlimited • BfR positive list • Migration tests (subdivided into cate- gories, depending on the contact time) USA (also accepted in Europe) Every accredited testing laboratory Material unlimited • FDA positive list • Migration tests USA NSF-certified laboratories Material and/or product 5 years with annual audit • FDA positive list • Migration tests USA (also accepted in Europe) Every accredited testing laboratory Material unlimited • FDA positive list • Resistance tests in defined media and classification according to specified limits Worldwide Each individual material supplier Material unlimited Testing of the formulation for animal- derived ingredients USA (also accepted in Europe) Licensed laboratories Material unlimited Testing of the compatibility on living organisms (in vitro) USA (also accepted in Europe) Licensed laboratories Material unlimited Testing of the compatibility on living organisms (in vivo) APPENDIX PRODUCT PORTFOLIO MATERIALS RESISTANCE & PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS INTRODUCTION 27

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