Contents, Miljøstyrelsen

Evaluation of Plasticisers for PVC for Medical Devices

Foreword
Summary and conclusions
Sammenfatning og konklusioner
1 Objective
2 Background
3 Procedure
3.1	Feasibility study
3.2	Industrial research
3.3	Publication and information
4 Activities during the project
5 The feasibility study
5.1	Plasticiser selection criteria
5.1.1	Availability
5.1.2	Compatibility towards PVC resins
5.1.3	Plasticising efficiency
5.1.4	Processability
5.1.5	Cost
5.1.6	Regulatory status
5.1.7	Environmental status
5.1.8	Physical properties of plasticiser
5.1.9	Physical properties of compounds
5.1.10	Public perception
5.2	Plasticiser performance matrix
5.3	Substances selected for further investigation
6 Experimental
6.1	Preparation of compounds, films and test specimens
6.1.1	Preparation of PVC compounds plasticised with the selected substances
6.1.2	Preparation by injection moulding of specimens for material characterisation
6.1.3	Preparation by roll milling of film samples for testing
6.2	Characterisation of the prepared compounds and of the alternative non-PVC material
6.2.1	Tensile properties determined on injection moulded specimens
6.2.2	Density of the prepared compounds
6.2.3	Indentation hardness determined on square injection moulded specimens
6.2.4	Cold flexibility
6.2.5	Tensile properties determined on roll milled film specimens
6.2.6	Light transmission determined on roll milled film specimens
6.3	Total assessment
7 Discussion
7.1	Uniformity of the compounds
7.2	Visual assessment of the prepared mouldings and films
7.3	Evaluation of the test results
7.3.1	Hardness
7.3.2	Density
7.3.3	Mechanical properties
7.3.4	Light transmission
7.4	Cost
7.5	Comments to each of the tested plasticising substances
7.6	Films versus tubings
7.7	Preliminary ranking of the investigated substances and compounds
7.8	General remarks
8 Conclusion
9 Proposal for further work
10 References

Appendix 1	Plasticiser performance matrix
Appendix 2	Injection moulding reports (in Danish only)
Appendix 3	Sources of the ingredients in the prepared PVC compounds and of the alternative thermoplastic material, evac
Appendix 4	Test reports from the tensile test of injection moulded specimens
Appendix 5	Test reports from the determination of torsional modulus versus temperature
Appendix 6	Test reports from the tensile test of roll milled films (in Danish only)
Appendix 7	Light transmission graphs