GB19082-2009 Medical Disposable Protective Clothing Testing

This standard specifies the requirements, test methods, markings, instructions for use, packaging, and storage of medical disposable protective clothing This standard is applicable to medical disposable protective clothing (hereinafter referred to as protective clothing) that provides barrier and protective effects for medical personnel who come into contact with potentially infectious patient blood, body fluids, secretions, particulate matter in the air, etc. during work

 

GB19082-2009 Medical Disposable Protective Clothing Testing Reference Standard:

GB/T191 Packaging, Storage and Transportation Pictorial Symbols (GB/T191-2008, IS0780:1997, MOD)

GB/T3923.1 Textiles and Fabrics - Tensile Properties - Part 1: Determination of Breaking Strength and Elongation at Break - Strip Method

GB/T4744 Textile Fabrics - Determination of Water Penetration Resistance - Hydrostatic Testing

GB/T4745 Textile Fabrics - Determination of Surface Moisture Resistance - Water Staining Test

GB/T5455 Textile Burning Performance Test - Vertical Method

GB/T5549 Surface Active Agents - Determination of Surface Tension by Pulling Liquid Film Method

GB/T12703 Textile Static Testing Method

GB/T12704 Method for determining the moisture permeability of fabrics - Moisture cup method

GB/T14233.1 Medical infusion, blood transfusion, and injection equipment - Part 1: Chemical analysis methods

GB/T14233.2 Medical infusion, blood transfusion, and injection equipment Injection equipment inspection methods Part 2: Biological test methods GB159792002 Hygienic standard for disposable hygiene products

GB/T16886.10 Biological evaluation of medical devices Part 10: Stimulation and delayed type hypersensitivity test (IsO10993-10:2002, IT)

IST40.2 (01) Non woven fabric static attenuation standard test method

Medical disposable protective clothing GB19082 testing requirements:

1. Appearance

Protective clothing should be dry, clean No mold stains, and no defects such as adhesion, cracks, or holes are allowed on the surface The connection part of protective clothing can be processed by needle stitching, bonding, or heat sealing. The needle hole of the needle seam should be sealed, with a needle spacing of 8-14 stitches every 3cm. The stitch should be uniform and straight, and there should be no skipped stitches. The parts processed by bonding or heat sealing should be flat, sealed, and free of bubbles Protective clothing with zippers should not have the zipper exposed and the zipper should be self-locking

2. Structure

Protective clothing consists of a hooded top and pants, which can be pided into a jumpsuit structure and a split structure.

The structure of protective clothing should be reasonable, easy to wear and take off, and the bonding area should be tight Elastic cuffs and ankle cuffs are used, while elastic cuffs, drawstring cuffs, or buckles are used for the face and waist of the hat

3. Size specifications

Protective clothing sizes are pided into 160, 165, 170, 175, 180, and 185

4. Liquid barrier function

(1) Anti permeability

The hydrostatic pressure of key parts of protective clothing should not be less than 1.67kPa (17cmH? O)

(2) Moisture permeability

The moisture permeability of protective clothing materials should not be less than 2500g/(m2? D)

(3) Anti synthetic blood penetration

The anti synthetic blood penetration of protective clothing should not be lower than the requirements of level 2 in Table 3.

(4) Surface moisture resistance

The water level on the outer side of protective clothing should not be lower than level 3

5. Breaking strength

The breaking strength of key parts of protective clothing materials should not be less than 45N

6. Breaking elongation

The breaking elongation of key parts of protective clothing materials should not be less than 15%

7. Filtration efficiency

The filtration efficiency of materials and seams in key parts of protective clothing for non oily particles should not be less than 70%. 4.8 Flame retardant performance

8. Flame retardant performance

Protective clothing with flame retardant performance should meet the following requirements:

a) The damage length should not exceed 200mm B) The ignition duration shall not exceed 15 seconds C) The smoldering time shall not exceed 10 seconds

9. Antistatic properties

The charged amount of protective clothing should not exceed 0.6pC/piece

10. Static attenuation performance

The static attenuation time of protective clothing materials should not exceed 0.5s

11. Skin Irritation

The score for primary irritation should not exceed 1

12. Microbial indicators

(1) Protective clothing should meet the requirements of microbial indicators in GB15979-202

(2) Protective clothing marked with the words "sterile" or "sterile" or illustrated on the packaging should be sterile

13. Ethylene oxide residue

Protective clothing sterilized with ethylene oxide should have an ethylene oxide residue of no more than 10ug/g

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