1. Who are the SBA member companies and what range of products do they produce?

Go to our Members page to find links to individual member sites.

2 .What legislation and standards apply for sterile barrier systems in Europe?

Look under our Regulatory section for guidance.

3. What is the significance of the CE Mark?

CE marking symbolises conformity to all the obligations incumbent on manufacturers for the product by virtue of the Community directives providing for its affixing. Read more about CE marking at http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/document/chap07.pdf

4. Are Sterile Barrier Systems required to have a CE mark?

Please refer to our position paper on CE Marking.

5. What are the arguments for using single use sterile barrier systems as opposed to reuseables?

Article - Sterilisation Wrap - The alternative to metal containers

Article -An end users view - Single use vs containers

Report by Australian Therapeutic Goods Adminstration - Health Issues associated with reusable medical devices -May 2004

Eucomed Medical Technology- March 2006

Do your own cost comparisons

6. Are Sterile Barrier Systems Covered by the Packaging and Packaging Waste Directive 2004/12/EC (amending Directive 94/62/EC)?

Please refer to our joint position paper with Eucomed.

7. What are the raw material trends for Sterile Barrier Systems?

Polymer price changes

Daily prices plastics

8. What is MRSA (Methicillin-Resistant Staphylococcis Aureus), what are the infection rates, what can be done to about it?

BBC News February 2005

World Health Organisation

Global patient safety

Personal experiences of MRSA

9.What factors can affect seal strength test results using EN 868-5 Annex D and should be taken into account when caring out comparisons?

Guidance in the use of seal strength test EN 868-5 Annex D