Foreword
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces GB 19082-2009 Technical requirements for single-use protective clothing for medical use. In addition to structural adjustments and editorial changes, the following main technical changes have been made with respect to GB/T 19082-2009:
a) The terms and definitions of "particle", "electrostatic decay" and "decay time" are deleted (see 3.1, 3.5 and 3.6 of Edition 2009);
b) The terms and definitions of "filtering efficiency" and "synthetic blood" are modified (see 3.1 and 3.2 hereof; 3.2 and 3.3 of Edition 2009);
c) The term “water-vapour transmission rate” and its definition are added (see 3.3 hereof);
d) The requirements of model & specification are deleted (see 4.3 of Edition 2009);
e) The requirements for tear strength, puncture resistance, joint strength, wear resistance and flexural failure resistance are added (see 4.3.1, 4.3.3, 4.3.4, 4.3.5 and 4.3.6 hereof);
f) The requirements for elongation at break are deleted (see 4.6 of Edition 2009);
g) The requirements for resistance to water penetration are modified (see 4.4.1 hereof; 4.4.1 of Edition 2009);
h) The requirements for antiphagin penetration are added (see 4.5.1 hereof);
i) The requirements for "water-vapour transmission rate" are modified (see 4.6 hereof; 4.4.2 of Edition 2009);
j) The requirements for flame retardant performance, microbial indexes are modified (see 4.7 and 4.10 hereof; 4.8 and 4.12 of Edition 2009);
k) The requirements for biocompatibility are added (see 4.9 hereof);
l) The requirements for electrostatic decay performance are deleted (see 4.10 of Edition 2009);
m) The requirements for skin irritation are deleted (see 4.11 of Edition 2009).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
The previous editions of this document are as follows:
——This standard was firstly issued in 2003 with the serial number of GB 19082-2003; and firstly revised in 2009;
——This is the second revision.
Introduction
Medical institution staff face a relatively high risk of pathogen exposure in scenarios such as the treatment, prevention and control of infectious disease patients, and infection control. They need to wear corresponding personal biological protective equipment to provide physical barriers, in order to minimize the risk of being infected with infectious substances from patients, environment, and other aspects. Biological protective clothing that can provide physical protection for medical personnel is managed according to Class II medical devices in China. Therefore, this mandatory national standard is formulated as a technical document that can be used as a basis for the production, inspection, supervision, and sampling of disposable protective clothing for medical use.
The manufacturers of disposable protective clothing for medical use are responsible for testing the products they produce in accordance with the requirements of this document. The performance indexes mainly include material physical performance, material biological protection performance, comfort, etc. Considering the practical use of medical scenarios and management requirements related to medical devices, this document also sets requirements for flammability, antistatic property, biocompatibility, microbial load, and ethylene oxide residue. In the process of formulating this document, for the setting of performance indexes for disposable protective clothing products, the first consideration is to meet the basic requirements of biological protection, while the actual use in medical scenarios. For applications beyond the scope specified in this document, if infectious pathogen protection is required in non-medical scenarios, users are responsible for conducting risk assessments and studying the feasibility of using the products applicable to this document.
This document specifies the minimum requirements for product performance. The manufacturers can develop and design products with higher performance levels based on the actual needs of users and the temperature and humidity usage conditions in different regions and climates to meet market needs. In addition, the manufacturers shall also consider ergonomics when designing clothing, optimize the structural design of protective clothing to improve the overall protective effect of protective clothing, and consider comfort (water-vapour transmission rate, moisture resistance, breathability, etc.). The overall protective performance can be tested and evaluated according to the methods specified in other relevant standards as needed.
Disposable protective clothing for medical use
1 Scope
This document specifies the requirements, markings, instructions for use, packaging, transportation, and storage of disposable protective clothing for medical use, and describes the corresponding test methods.
This document is applicable to disposable protective clothing for medical use (hereinafter referred to as "protective clothing") worn by personnel of medical institutions in situations where they may come into contact with infectious blood, body fluids, secretions, particulate matter in the air, and other potential exposure risks during medical and disease prevention and control work.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 3917.3 Textiles - Tear properties of fabrics - Part 3: Determination of tear force of trapezoid-shaped test specimens
GB/T 4744-2013 Textiles - Testing and evaluation for water resistance - Hydrostatic pressure method
GB/T 4745-2012 Textiles - Testing and evaluation for water resistance - Spray test method
GB/T 12703.3-2009 Textile - Evaluation for electrostatic properties - Part 3: Electric charge
GB/T 12704.1-2009 Textiles - Test method for water-vapour transmission of fabrics - Part 1: Desiccant method
GB/T 13773.2 Textiles - Seam tensile properties of fabrics and made-up textile articles - Part 2: Determination of maximum force to seam rupture using the strip method
GB/T 14233.1-2022 Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 20655 Protective clothing - Mechanical properties - Determination of the resistance to puncture
GB/T 24218.3 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
GB 24539-2021 Protective clothing - Chemical protective clothing
YY 0469 Surgical mask
YY/T 0689-2008 Clothing for protection against contact with blood and body fluids - Determination of resistance of protective clothing materials to penetration by blood-borne pathogens - Test method using Phi-X 174 bacteriophage
YY/T 0700-2008 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood
Pharmacopoeia of the People's Republic of China (Edition 2020) Volume IV
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
particle filtration efficiency
percentage of particle in the air filtered out by protective clothing materials under specified testing conditions
3.2
synthetic blood
mixture composed of red dye, surfactant, thickener and distilled water
Note: Its surface tension and viscosity can represent blood and other bodily fluids, and have a color similar to blood.
3.3
water-vapour transmission rate
mass of water vapor passing vertically through a unit area of the specimen within a specified time under the specified temperature and humidity conditions on both sides of the specimen
Note: It is expressed in g/(m2·h) or g/(m2·24h).
[Source: GB/T 12704.1-2009, 3.1]
4 Requirements
4.1 Basic requirements
The materials and structure design of protective clothing shall meet the following requirements:
a) The protective clothing shall be dry, clean, and free of mold, surface adhesion, cracks, holes, and other defects.
b) The connection part of the protective clothing is flat, sealed, and free of bubbles.
c) The zippers equipped with protective clothing shall be exposed, and the zipper shall be able to lock.
d) The cuffs and ankle cuffs of protective clothing are elastically closed, while the hat and waist are elastically closed, closed by pulling ropes or buckle latch to ensure a tight fit.
4.2 Dimension
The body length, sleeve length, chest circumference, cuffs, and ankle opening of protective clothing shall meet the dimension and tolerance requirements specified by the manufacturer.
4.3 Physical properties of materials
4.3.1 Tear force
The tear force shall not be lower than the Grade 1 in Table 1.
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking and instructions for use
7 Packaging, transportation and storage
Bibliography
