PALL NanodyneTM ELD Filter and PALL Posidyne ELD Filter

Product definition

Article. These products are not classified as hazardous according to REACH Regulation 1907/2006, or European CLP/GHS Regulation 1272/2008.

Signal word

No signal word.

Hazard statements

No known significant effects or critical hazards.

Special packaging requirements

None. ____________________________________________________________________________________ SECTION 3 - Materials of Construction The filters detailed in Section 1 are comprised of the following materials: Filter assembly (All codes) Material Name CAS Number Modified acrylic copolymer housings Supplier proprietary information Polyamide main membrane Pall proprietary information Black Ink Pall proprietary information Polytetrafluoroethylene (PTFE) vent membrane 9002-84-0 Polyester vent membrane non-woven support 25038-59-9 Set components Material Name Product codes CAS Number DEHP free PVC tubing ELD96LLCE, 9002-86-2 ELD96LYLE, ELD96LL, ELD96LYL, ELD96LYLS, ELD96NYS, ELD96NY, ELD96LLCJ, 100-0105 MABS male luer connector ELD96LLCE, 9010-94-0 ELD96LYLE, 100-0105, ELD96LYLS, ELD96NYS Acrylic male luer connector ELD96LL, ELD96LYL, Trade secret ELD96LLCJ, ELD96NY Orange polyethylene hexene copolymer ELD96LLCE, 25213-02-9 cap on male luer ELD96LYLE, 100-0105 Polyethylene cap on male luer ELD96NT, ELD96NTE 9002-88-4 Polyethylene dual protective cap ELD96LL, ELD96LYL, 9002-88-4 ELD96LYLS, ELD96LLCJ, ELD96NY, ELD96NYS Polyethylene hexene copolymer slide ELD96LLCE, 25213-02-9 clamp ELD96LYLE, ELD96LYL, ELD96NY, 100-0105 Polyethylene slide clamp ELD96LYLS, ELD96NYS 9002-88-4 Polypropylene slide clamp ELD96LLCJ 9003-07-0 Acrylonitrile-butadiene-styrene copolymer ELD96LLCE, 9003-56-9 (ABS) cap on female luer ELD96LYLE, 100-0105, ELD96NT, ELD96NTE Y connector – injection septum Acrylic – Supplier ELD96LYLE, ELD96LYL, proprietary information ELD96LYLS Synthetic Polyisoprene 9003-31-0 Y connector – needle-free access Acrylic – Supplier proprietary information, ELD96NY, ELD96NYS Silicone Rubber – Supplier proprietary information Polyurethane 9009-54-5 Polypropylene Rotating hub ELD96NT, ELD96NTE 9003-07-0 These products are not known to contain BADGE, NOGE, or BFDGE. Trace additives will be present in the plastic components. There are no additional ingredients present which, within the current knowledge of the supplier, are classified and contribute to the classification of the article. There are no current SVHC substances known to be present in the finished articles above 0.1%. There are no current ROHS2 Directive (2011/65/EU) and amendment (2015/863) substances of concern (including Lead, Cadmium, Mercury, Hexavalent Chromium, Polybrominated biphenyl (PBB), Polybrominated diphenyl ether (PBDE), Bis(2-ethylhexyl) phthalate (DEHP), Benzyl Butyl Phthalate (BBP), Dibutyl phthalate (DBP) and Di-isobutyl phthalate (DIBP)) known to be present in the materials employed in excess of the limits laid down, based on information from our suppliers and knowledge of substances used within Pall the manufacturing facility. Pall Medical filters do not employ natural rubber latex, or latex derivatives in their construction. Pall Medical products do not knowingly contain materials of direct animal origin i.e. animal parts, tissues, or body fluids however, to assist our customers in performing a TSE/BSE risk assessment, we are pleased to provide the following information: Certain plastics are known to contain trace levels of additive (e.g. calcium stearate) which are manufactured from tallow. Pall Medical products may utilize components in the fluid pathway which are fabricated from plastic resins containing tallow-derived additives at trace levels, but Pall does not test for them. Please be advised that bovine tallow-derived additives are not considered specified TSE/BSE risk materials according to the current revision of the U.S. Code of Federal Regulations, Title 21 of part 189.5, which defines specified risk material for human food and Regulation (EU) 722/2012 concerning medical devices manufactured using tissues of animal origin, in Article 4, specifically excludes tallow derivatives provided they have been processed under conditions at least as rigorous as those stated in Section 3 of Annex 1 as shown below: • Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production), • Saponification with NaOH 12 M (glycerol and soap production) • Batch process: at not less than 95 °C for not less than 3 hours, • Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent, • Distillation at 200 °C. The plastics raw materials we purchase have been processed with one of these steps. Pall continuously works to assure the safety of our products with respect to potential BSE/TSE transmission by working through our supply chain to obtain information regarding the possible use of animal-based material and to confirm specific sourcing and processing details where applicable ______________________________________________________________________________________