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FEATURES
Triple contact rubber piston. High transparency polypropylene. Highly legible and stable graduated scale. High penetrability needle. End stroke piston stop device. In single blister
Medical device according to directive 93/42 EEC Implementation with Legislative Decree No. 46 of 02-24-97 Class II A
Compliance: ISO 594-1 Conical Luer connections 6% ISO 7864 Disposable hypodermic needles ISO 7886 Sterile disposable syringes ISO 2859 Sampling plans ISO 6009 Color coding of identification ISO 683/12 Stainless steel EN 550 Sterilization ISO 10993 Biocompatibility Quality Assurance System: certified according to UNI EN ISO 9001: 2000 Quality Assurance System: certified according to UNI EN ISO 13485: 2004
Stairs division: Nominal volume: 1 ml Graduation up to: 1 ml Min division: 0.01 ml Standard: ISO 8537
Technical specifications: COMPONENT: Cylinder, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002; COMPONENT: Piston, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002; COMPONENT: Rubber, MATERIAL: Latex-free compound, COMPLIANCE: FU / FE in force; COMPONENT: Silicone, MATERIAL: Non-toxic and non-pyrogenic for medical use Max Qty 0.25 mg / cm2, COMPLIANCE: FE / U.S.P. in force; COMPONENT: Conect, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002; COMPONENT: Cannula, MATERIAL: AISI 304 stainless steel, CONFORMITY: ISO 683/13; COMPONENT: Needle cover, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002; COMPONENT: Glue, MATERIAL: Epoxy-non-toxic glue, COMPLIANCE: EEC Directive 91/155; COMPONENT: Screen printing ink, MATERIAL: Non-toxic specific for polypropylene, CONFORMITY: Ministerial Decree 21-03-73 and subsequent amendments.
Presence of latex: NO
Product sterilization method: Ethylene Oxide Gas in accordance with EN 550
Packaging material: Component: Single blister, Material: Medical paper, Compliance: F.D.A (section 21-CFR176-170); Component: Single blister, Material: Thermoformed tray in PVC coupled with PE + PP + PA, Compliance: Ministerial Decree 21-03-73 and subsequent amendments. |
