1 Scope
This standard specifies the requirements, test methods, marks, instructions for use, packaging and storage for single-use protective clothing for medical use.
This standard is applicable to the single-use protective clothing for medical use (hereinafter referred to as protective clothing) that provides barrier and protective effect for medical personnel to contact with blood, body fluids, secretions and particles in the air of patients with potential infection during work.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 191 Packaging — Pictorial Marking for Handling of Goods (GB/T 191-2008, ISO 780:1997, MOD)
GB/T 3923.1-1997 Textiles — Tensile Properties of Fabrics — Part 1: Determination of Breaking Force and Elongation at Breaking Force — Strip Method
GB/T 4744-1997 Textile Fabrics — Determination of Resistance to Water Penetration — Hydrostatic Pressure Test (eqv ISO 811:1981)
GB/T 4745-1997 Textile Fabrics — Determination of Resistance to Surface Wetting — Spray Test (eqv ISO 4920:1981)
GB/T 5455-1997 Textiles — Burning Behaviour — Vertical Method
GB/T 5549-1990 Surface Active Agents — Determination of Surface Tension by Drawing up Liquid Films
GB/T 12703-1991 Electrostatic Test Methods for Textile
GB/T 12704-1991 Fabrics — Determination of Water Vapour Transmission Rate — Dish Method
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use — Part 2: Biological Test Methods
GB 15979-2002 Hygienic Standard for Disposable Sanitary Products
GB/T 16886.10-2005 Biological Evaluation of Medical Devices — Part 10: Tests for Irritation and Delayed-type Hypersensitivity (ISO 10993-10:2002, IDT)
IST 40.2(01) Standard Test Method for Electrostatic Decay Nonwoven Fabrics
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Mark and Instructions for Use
7 Packaging and Storage
Annex A (Normative) Determination of the Penetration Resistance of Protective Clothing — Test Method Using Synthetic Blood
Bibliography
