SAFETY DATA SHEET Afinion Lipid Panel Control

Transcription

1 Afinion Lipid Panel Control Page 1 of 6 SAFETY DATA SHEET Afinion Lipid Panel Control SECTION 1: Identification of the substance/mixture and of the company/undertaking Date issued Product identifier Product name Afinion Lipid Panel Control 1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/preparation Uses advised against 1.3. Details of the supplier of the safety data sheet Producer Company name Axis-Shield PoC AS Office address Kjelsåsveien 161 Postal address PO Box 6863 Rodeløkka Postcode NO-0504 City Oslo Country Norway Tel Fax pocweb@axis-shield.com Control material for Afinion Lipid Panel. (The Afinion Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig), in whole blood, serum and plasma. Values for low-density lipoprotein (LDL) cholesterol, non-hdl cholesterol and Chol/HDL ratio are calculated by the Afinion AS100 Analyzer.) For in vitro diagnostic use only Emergency telephone number Emergency telephone National emergency number :For each country. SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification notes Not classified according to 67/548/EEC or 1999/45/EC Label elements Other Label Information 2.3. Other hazards Description of hazard Other hazards The product is not classified according to 67/548/EEC or 1999/45/EC and has no labelling. May cause sensitization by skin contact. Potential infectious agent. May be harmful if exposed by inhalation, ingestion or skin adsorption. May cause irritation. This safety data sheet is valid for Afinion Lipid Panel Control. Contains human blood derivatives. No known test method can offer complete assurance that products derived from human blood will not transmit infectious

2 Afinion Lipid Panel Control Page 2 of 6 agents. Consider all blood derivatives potentially infectious. SECTION 3: Composition/information on ingredients 3.2. Mixtures Component name Identification Classification Contents Human Source Material % Neomycin sulphate CAS no.: < 1 % SECTION 4: First aid measures 4.1. Description of first aid measures Inhalation Supply fresh air immediately. Seek medical attention if breathing difficulty occurs. Skin contact Wash with soap and plenty of water. Seek medical attention if symptoms of skin irritation occurs. Eye contact Immediately flush with plenty of water or eyewash solution for up to 10 minutes. Contact physician. Ingestion Wash mouth thoroughly with water. Seek medical attention Most important symptoms and effects, both acute and delayed Information for health personnel Wear suitable gloves and eye/face protection Indication of any immediate medical attention and special treatment needed Other Information No recommendation given. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Improper extinguishing media Use extinguishing media appropriate for surrounding fire. None Special hazards arising from the substance or mixture Fire and explosion hazards Not flammable. This product does not represent any fire or explosion hazard Advice for firefighters Personal protective equipment Use self-contained breathing apparatus and protective suite. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions Ensure adequate ventilation. Handle as potentially infectious Environmental precautions Environmental precautions Rejection forbidden to the sewer and in natural environment Methods and material for containment and cleaning up Methods for cleaning 6.4. Reference to other sections Other instructions SECTION 7: Handling and storage 7.1. Precautions for safe handling Handling Wipe up with absorbent material. Place in suitable container for disposal. Label container as to potential infectous hazard. Spill areas can be decontaminated with 0.5% sodium hypochlorite e.g. a fresh 1:10 dilution of common household bleach. See section 8 and 13 for use of personal protective Equipment and Waste disposal. Wear gloves and protective clothing. Wear disposable gloves while handling reagent. Thoroughly wash hands afterwards Conditions for safe storage, including any incompatibilities

3 Afinion Lipid Panel Control Page 3 of 6 Storage Special risks and properties 7.3. Specific end use(s) Recommendations Storage according to package Insert and outer - container. The product should be handled as potentially bio hazardous materials. None specific. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Other Information about threshold No known occupational exposure limits. limit values 8.2. Exposure controls Occupational exposure controls Respiratory protection Respiratory protection Hand protection Hand protection Reference to relevant standard Eye / face protection Eye protection Reference to relevant standard Skin protection Suitable protective clothing All handling to take place in well-ventilated area. Eye Washing Station should be available. Personal protection equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Respiratory protection not required. Normal use: Hand protection is recommended. Wear disposable gloves. (Latex gloves). Clean up after accidental release or leakage: Use hand protection. (Nitrile gloves). EN-374: 2003, parts 1, 2 and 3: Protective gloves against chemicals and micro-organisms. Normal use: Not necessary. Clean up after accidental release or leakage: Wear safety glasses. CEN/CR: 13464:1999 Guide to selection use and maintenance of occupational eye and face protectors. EN 166:2001 Personal eye-protection - Specifications. EN 168:2001 Personal eye-protection - Non-optical test methods. Lab Coat is recommended. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state Liquid Colour Straw colored. Odour Mild odor. s, Flash point Not applicable. s, Explosion limit Explosion Limits: None. Solubility in water Readily miscible with water Other information Other physical and chemical properties Physical and chemical properties No data recorded. SECTION 10: Stability and reactivity Reactivity Reactivity No data recorded.

4 Afinion Lipid Panel Control Page 4 of Chemical stability Stability Possibility of hazardous reactions Possibility of hazardous reactions No recommendation given Conditions to avoid Conditions to avoid No recommendation given Incompatible materials Materials to avoid No data recorded Hazardous decomposition products Hazardous decomposition products None known. Other information Other Information Stable under recommended storage conditions. Hazardous polymerization: Does not occur. SECTION 11: Toxicological information Information on toxicological effects Potential acute effects Inhalation No data available. Eye contact Ingestion Delay / Repeating Chronic effects Contact with eyes may cause irritation. No data available. Oral: No data available. Inhalation: No data avaliable. Dermal: No data available. Carcinogenic, Mutagenic or Reprotoxic Carcinogenicity SECTION 12: Ecological information Toxicity Aquatic, comments Contains CAS no: Chloramphenicol IARC: 2A Contains very small amounts of Chloramphenicol which is classified as: Harmful to aquatic organisms. May cause long-term adverse effects in aquatic environment Persistence and degradability, Biodegradability No data available. Persistence and degradability No data available Bioaccumulative potential Bioaccumulative potential No data available on bioaccumulation Mobility in soil Mobility No data available Results of PBT and vpvb assessment PBT assessment results Not known Other adverse effects Environmental details, conclusion Not known. SECTION 13: Disposal considerations Waste treatment methods Specify the appropriate methods of disposal Dispose as infectious waste. To be disposed according to national regulations. Rejection forbidden to the sewer and in natural environment. Ref. section 6 for methods for clean up.

5 Afinion Lipid Panel Control Page 5 of 6 Relevant waste regulation Directive 2008/98/EC of the European Parliament and of the council of 19 November 2008 on waste and repealing of certain directives. Product classified as hazardous Yes waste EWC waste code EWC: * wastes whose collection and disposal is subject to special requirements in order to prevent infection Other Information The given EWC-code(s) are guidlines only. The end user has to choose the correct code(s) based on the actual use of the product. Used device should be handled and disposed as potentially bio hazardous materials. SECTION 14: Transport information UN number UN proper shipping name Transport hazard class(es) Packing group Environmental hazards Special precautions for user Special precautions for user Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Pollution category Other applicable information. Other applicable information. The product is not subject to transport regulation. Used product should be considered infectious waste, and transported in accordance with applicable transport regulations. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture References (laws/regulations) Council Directive 67/548/EEC of 27 june 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packageing and labelling of dangerous substances. Directive 1999/45/EC of The European Parliament and of The Council of 31 may 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Regulation (EC) No 1272/2008 of The European Parliament and of The Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency. Commission Regulation (EU) No 453/2010 of 20 May 2010, amending Regulation (EC) No 1907/2006 REACH. Directive 98/79/EC of The European Parliament and of The Council of 27 October 1998 on in vitro diagnostic medical devices. Directive 2008/98/EC of the European Parliament and of The Council of 19

6 Afinion Lipid Panel Control Page 6 of Chemical safety assessment Chemical safety assessment has been carried out November 2008 on waste and repealing of certain directives. International Transport Regulation: ADR/RID, IMDG, IATA. No SECTION 16: Other information Supplier's notes Recommended restrictions on use Sources of key data used to compile the safety data sheet Checking quality of information User notes Responsible for safety data sheet The safety data sheet has been compiled, controlled and approved in accordance with the regulations in force. BIS Production Partner is not responsible for any errors or deficiencies in the information received from the manufacturer/importer/supplier. The manufacturer/importer/supplier mentioned in section 1 is legally responsible for the contents of the safety data sheet. For in vitro diagnostic use only. Material safety datasheet from the Manufacturer dated 8/25/2011. This Safety Data Shees has been quality checked by BIS Production Partner AS, who has a NS-EN ISO 9001 certificate. The material safety data sheet has been compiled in accordance with the regulations in force. BIS Production Partner AS is not responsible for any errors ordeficiencies in the information received from the manufacturer/importer/supplier. The manufacturer/importer/supplier mentioned in section 1 is legally responsible for the contents of the safety data sheet. Axis-Shield PoC AS