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BIOFLEX
STATEMENT ON COMPLIANCE TO REGULATIONS ON MEDICAL USE
We confirm that the material used in the fabrication of Bioflex products in its pure form without additives fulfils the requirements on materials used for articles or components of articles intended for medical use as described in:
Council of Europe European Pharmacopoeia, 3rd edition (1997), and Supplement2001, Monograph 3.2.2
USA The product has passed the Class VI tests (Bio-compatibility) of the United States Pharmacopoeia XXIV and has been assigned the FDA Drug Master file.
Additional Information: The material has successfully passed the biological tests according to ISO 10993? external communicating deviced for indirect blood contact for a prolonged period.
SAFETY DATA SHEET
1. Identification of the Manufacturer
Euro piece Worldwide Ltd.
2. Information on Ingredients
The material used for Bio-flex products contains no substance classified as hazardous, in concentrations which should be taken into account according to EC directives.
3. Hazards Identification
The product is not classified as a dangerous preparation (EC)
4. First aid measures
No specific instructions needed
5. Fire fighting measures
Extinguishing agents. Water in spread jet, dry chemical, foam or carbon dioxide should be used. The product burns, but is not classified as flammable. Principal toxicant in the smoke is carbon monoxide.
6. Accidental release measures
All spill of Bioflex Products must be removed immediately to prevent slipping accidents.
7. Handling and Storage
To be stored in a clean and dry condition and at ambient temperature.
8. Physical and Chemical Properties
Appearance: Finished products in the shape of balls or bars/disc., odourless, transparent ignition temperature:> 300 3 Solubility : insoluble in water.
The product can be sterilized by steam.
9. Stability and reactivity
The product is a stable thermoplastic, with no chemical reactivity.
10. Toxicological Information
The product is not dangerous.
11. Ecological Information
The product is not considered dangerous for the environment.
12. Disposal considerations
Reuse or recycle if not contaminated. The product may be safely used as fuel or landfill. Proper combustion does not require any special flue gas control. No leakage is generated in landfills. Check with local regulations.
13. Transport Information
The product is not regulated by ADR/RID, IMDG or IATA.
14. Other Information
Application: Finished product to be used in the cosmetic body jewellery Industry.
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| Why Bioflex? |
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Highly bio-compatible, it reduces the chances of any allergic reaction to almost zero.. and has zero nickel content! Fully complies with the European Union Nickel Directives! Save money by getting it right the first time with your piercing!
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It withstands temperature beyond autoclaving temperatures - so you can boil it - and we would advise you to do so anyway before you insert it into your piercing! and a remarkable chemical resistance allows you to use any other form of sterilisation.
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All you need is a pair of scissors or a sharp blade to reduce the length of your BioFlex bar to exactly the length that is right for you. Allow extra length for swelling in fresh piercings, then as the swelling reduces, you can reduce the lenth of the bar!... again that's how you save money!!! You don't need to buy shorter lengths.
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Highly flexible -- it moves with the body.. for maximum comfort and durability. So comfortable that you will forget it's there! Perfect for sports fanatics, expectant mothers and physical workes.
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| Unlike metal bars, it has an almost zero co-efficient of conductivity... this means you can lay in the sun without your jewelry drawing the heat into your piercings. |
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Once of the most appreciated properties of BioFlex is that it is transparent. A Labret can be worn reversed, so that it can barely be seen. Ideal if you are in the military, school or any employment where personal presentation is paramount. Enjoy wearing your piercing normally during leisure hours and hide it at work.
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