GB 19082-2009 Technical (Nov 28, 2022)
Original title: GB 19082-2009 Technical Standard for Medical Disposable protective suit This standard specifies the requirements, test methods, marks, instructions for use, packaging and storage of medical disposable protective suit. This standard is applicable to the medical disposable protective suit (hereinafter referred to as protective suit) that provide barrier and protection for medical staff to contact potentially infectious blood,3 Ply Disposable Protective Face Mask, body fluids, secretions and particulate matter in the air. Reference standard: GB/T191 Pictorial Marks for Packaging, Storage and Transportation (GB/T191-2008,Medical Full Body Coverall, IS0780: 1997, MOD) GB/T3923.1 Textiles-Tensile properties of fabrics-Part 1: Determination of breaking force and elongation at break-Strip method GB/T4744 Textile Fabrics-Determination of Resistance to Water Penetration-Hydrostatic Pressure Test GB/T4745 Textile fabrics--Determination of resistance to surface wetting--Water test GB/T5455 Textiles-Test for flammability-Vertical method Surface active agents--Determination of surface tension by drawing up liquid films GB/T12703 Electrostatic Test Method for Textiles GB/T12704 Determination of Moisture Vapor Transmission of Textile Fabrics--Moisture Vapor Transmission Cup Method GB/T14233.1 Test Methods for Infusion, Transfusion and Injection Equipment for Medical Use Part 1: Chemical Analysis Methods GB/T14233.2 Test methods for infusion, transfusion and injection equipment for medical use Part 2: Biological test methods GB159792002 Hygienic standard for disposable sanitary products GB/T16886.10 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Delayed Type Hypersensitivity (ISO 10993-10: 2002, Full Body Disposable Coverall ,CE Certificate KN95 Mask, IT) IST 40.2 (01) Standard Test Method for Electrostatic Decay of Nonwoven Fabrics Test requirements for medical disposable protective suit GB19082: 1. Appearance The protective suit shall be dry, clean and free of mildew, and the surface shall be free of adhesion, cracks, holes and other defects. The connection part of the protective suit can be processed by needling, bonding or heat sealing. Needle holes shall be sealed, and the stitch spacing shall be 8-14 stitches per 3cm. The stitches shall be even and straight, and there shall be no skipped stitches. Parts after processing such as bonding or heat sealing shall be smooth, sealed and free of bubbles. The zipper of the protective suit with zipper shall not be exposed, and the pull head shall be self-locking. 2. Structure The protective suit consists of a hooded jacket and trousers and can be divided into a one-piece structure and a split-body structure. The structure of the protective suit should be reasonable, easy to wear and take off, and the joint position should be tight. Expand the full text The cuffs and ankles shall be closed with elasticity, and the face and waist of the hat shall be closed with elasticity, drawstring or buckle. 3. Size and specification The protective suit is divided into 160, 165,KN95 Face Mask, 170, 175, 180 and 185. 4. Liquid barrier function (1) Water permeability resistance The hydrostatic pressure at critical locations of the protective suit shall not be less than 1.67 kPa (17 cmH? O). (2) Moisture permeability The moisture permeability of protective suit materials shall not be less than 2500 G/ (m2? D). (3) Resistance to synthetic blood penetration The resistance of the protective suit to the penetration of synthetic blood shall be not less than the requirements of Grade 2 in Table 3. (4) Surface moisture resistance The water level on the outer side of the protective suit shall not be lower than the requirement of Level 3 5. Breaking strength The breaking strength of the material at the key part of the protective suit shall not be less than 45N 6. Elongation at break The elongation at break of materials at key parts of the protective suit shall not be less than 15%. 7. Filtration efficiency The filtration efficiency of the materials and joints at the key parts of the protective suit for non-oily particles shall not be less than 70% 4.8 Flame retardant performance 8. Flame retardant performance Protective suit with flame retardant properties shall meet the following requirements: A) The damaged length is not more than 200mm; B) The afterburning time shall not exceed 15 s; C) The smoldering time shall not exceed 10 s. 9. Antistatic property Electrification of protective suit shall not be more than 0.6pC/piece. 10. Electrostatic attenuation performance The electrostatic decay time of the protective suit material shall not exceed 0.5s. 11. Skin irritation The primary irritation score should not exceed 1. 12. Microbial indicators (1) The protective suit shall meet the requirements of microbial indicators in GB15979-202. (2) protective suit marked with the word "Sterilized" or "Sterile" or pictogram on the package shall be sterile. 13. Ethylene oxide residue The residual ethylene oxide in the protective suit sterilized by ethylene oxide shall not exceed 10 UG/G. Return to Sohu to see more Responsible Editor:. zjyuan-group.com
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