General Description: Spray/aerosol-penetration resistant, biohazard-protective coverall, for use in EVD patient-isolation units for infection prevention and control against viral penetration. Technical specifications Product name: Coverall type 4B/5B/6B Elasticated hood around face. Elasticated cuffs and ankles. Elasticated sleeves. Taped seams. Zipper with re-sealable flap protecting leakage through seams. Stitched-in neck label indicating the type and performance of the suit against the below mentioned standards. White color with blue tape Material: 65 GSM Non-woven PP+PE 65 GSM +/- 2gsm Lightweight, do not contain rubber/ latex. Antistatic treated on both sides. Fabric is Infective agent tested against viral penetration at minimum 1.75kPa (class 2) (or equivalent international standard) Non-sterile Single Use, disposable Size: M-XL Conforms to standards below: European Directive 89/686/EEC on personal protective equipment Category III: Chemical protective coverall, comply with Type 4B/5B/6B including below standards. EN 13034:2005+A1 EN 14605 EN ISO 13982-1 EN 1073-2 EN ISO 13688 EN 1149-5 Barrier to infective agent standards: EN 14126:2003 certified passing infectious agent test according to ISO 16604:2004 (Resistance to penetration by blood borne pathogens using bacteriophage Phi X 174) standard at minimum exposure pressure of 1.75kPa (class 2) (or equivalent international standard) Performance requirement ISO standards: EN 340 General requirements EN ISO 17491-4: 2008 (supersedes: EN 468 mod. Spray aerosol test) EN 14325 Test methods & performance classification EN ISO 3758 (ISO 3758) Textile care symbols EN ISO 13935-2 Seam strength Certificates CE from notified body ISO13485 Supplied with Supplier's instruction for use Shelf life : As indicated by supplier Storage conditions : As indicated by supplier Packaging and labelling : Individually packaged in a transparent plastic bag. Labelling of the primary packaging displays, at least: product name, product reference, manufacturer name, size, type, coverall performance testing information against the mentioned standards. Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable. All indicated at least in English
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