Product manufacturing from zirconium oxide

Transcription

1 Product Safety Data Sheet: Product manufacturing from zirconium oxide Company undertaking identification Nobel Biocare AB P.O Box 5190 SE Göteborg, Sweden Hazards Identification Classified not dangerous Composition/information On Ingredients Element Compositional limits % by weight Zirconia + Hafnium Oxide + Yttrium Oxide ZrO2 + HfO2 + Y2O3 > 99,0 Yttrium Oxide Y2O3 > 4,5 to < 6,0 (percent mass fraction) Hafnium Oxide HfO2 < 5 (percent mass fraction) Aluminum Oxide Al2O3 < 0,5 Other oxides Other oxides < 0,5 1 (5)

2 First Aid Measures Accidental Release Measures Personal protection/precautions Environmental precautions Handling And Storage Handling Normal handling, no precaution Storage Normal condition, no precaution Exposure Controls/Personal Protection Eye protection, during preparation of the product use safety glasses Physical and Chemical properties General information Solid Important health, safety and environmental information 2 (5)

3 Other information This product is a medical device on all available markets. Stability and Reactivity Conditions to avoid/reactivity Non, if used in accordance to Instruction For Use. No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this International Standard has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. Material to avoid Non, if used in accordance to Instruction For Use. Hazardous decomposition products Toxicological Information No toxicological effects. Ecological information Ecotoxicity No ecological impact Disposal considerations Provisions relating to waste Non hazardous waste Disposal methods 3 (5)

4 Recycle or dispose of in accordance with Local, State and Federal Waste Disposal Regulations Packaging/container Recycling Regulatory information Zirconium oxide chemically complies with ISO Labeling as specified in the Council Directive 93/42/EEC and/or the FDA Food, Drug and Cosmetic Act. Other information The information provided on this PSDS is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as guidance for safe handling, use, processing, storage, disposal and release and is not to be considered as a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other material or in any process, unless specified in the text. N.A. = NOT APPLICABLE N.D. = NOT DETERMINED (*) = INTERNAL CLASSIFICATION (NFPA) - Product Safety Data Sheet (PSDS) regards only products. - Material Safety Data Sheet (MSDS) regards only substances and preparations based on Regulation (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - The packaging material comply to the European Parliament and Council Directive 94/62/EC on packaging and packaging waste. - ISO 13356: Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) Revision history 4 (5)

5 Version <Ver nr> Description of changes <Write changes from the previous version here> 5 (5)