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 standard is developed in accordance with the rules given in GB/T 1.1-2009.
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 standard was proposed by China National Textile and Apparel Council.
This standard is under the jurisdiction of the National Technical Committee 209 on Textiles of the Standardization Administration of China (SAC/TC 209).
Textiles—Nonwoven fabrics for isolation gowns
1 Scope
This standard specifies the product classification, technical requirements, test methods, inspection rules, packaging, marking, storage and transportation of nonwoven fabrics for isolation gowns.
This standard is applicable to nonwoven fabrics for disposable isolation gowns worn by medical staff and visitors.
2 Normative references
The following referenced documents are indispensable for the application 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 250 Textiles—Tests for colour fastness—Grey scale for assessing change in colour
GB/T 4666 Textiles—Fabrics—Determination of width and length
GB/T 7742.1 Textiles—Bursting properties of fabrics—Part 1: Hydraulic method for determination of bursting strength and bursting distension
GB/T 12703.4 Textile—Evaluation for electrostatic properties—Part 4: Resistivity
GB/T 12704.1-2009 Textiles—Test method for water-vapour transmission of fabrics—Part 1: Desiccant method
GB 15979-2002 Hygienic standard for disposable sanitary products
GB 19082-2009 Technical requirements for single-use protective clothing for medical use
GB/T 24218.1 Textiles—Test methods for nonwovens—Part 1: Determination of mass per unit area
GB/T 24218.3 Textiles—Test methods for nonwovens—Part 3: Determination of tensile strength and elongation (strip method)
GB/T 24218.16 Textiles—Test methods for nonwovens—Part 16: Determination of resistance to penetration by water (hydrostatic pressure)
GB/T 24218.17 Textiles—Test methods for nonwovens—Part 17: Determination of resistance to penetration by water (spray impact)
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
3 Product classification
The nonwoven fabrics for isolation gowns are classified by their inherent quality requirements into Class I, Class II, Class III and Class IV with gradually increasing protective performance.
Notes: Class I refers to isolation gowns generally used for visitors, cleaners and other purposes.
Class II refers to isolation gowns generally used for routine care and examination.
Class III refers to isolation gowns generally used for occasions where patients have a certain amount of bleeding and liquid secretions.
Class IV refers to improved isolation gowns generally used for long-term or large-scale exposure to patients' blood, body fluids or clean medical waste.
4 Technical requirements
4.1 Inherent quality
The inherent quality of nonwoven fabrics for isolation gowns shall be in accordance with those specified in Table 1.
Table 1 Inherent quality requirements
Assessment item Performance indicator
Class I Class II Class III Class IV
Mass deviation rate per unit area
% ±6
Spray impact seepage
g ≤4.5 ≤1.0 ≤1.0 Not required
Hydrostatic pressure
kPa Not required ≥1.8
(18 cmH2O) ≥4.4
(45 cmH2O) ≥9.8
(100 cmH2O)
Resistance to microbial penetration Not required Not required Not required Acceptable a
Resistance to synthetic blood penetration
Level Not required Not required Not required ≥4
Bursting strength
kPa ≥40
Tensile strength
N ≥20 ≥20 ≥30 ≥45
Water-vapour permeability rate
g/(m2·24h) ≥3600
Antistatic property
(Surface resistivity)
Ω Not required ≤1×1012
a The resistance to microbial penetration is assessed in accordance with YY/T 0689-2008.
4.2 Microorganisms
The microbial indicator of nonwoven fabrics for isolation gowns shall be in accordance with those specified in Table 2.
Table 2 Requirements for microbial indicators
Item Requirement
Total bacterial count
CFU/g ≤150
Total number of fungal colonies
CFU/g ≤80
Coliform Not detected
Pathogenic pyogenic bacteria Not detected
Note: Pathogenic pyogenic bacteria refer to pseudomonas aeruginosa, staphylococcus aureus and streptococcus hemolyticus.
4.3 Appearance quality
4.3.1 The cloth shall be even and flat, and neatly wrapped, free of micropores and crystal points, obvious creases, broken edges and holes, oil stains and spots.
4.3.2 Width deviation shall be in accordance with those specified in Table 3.
Table 3 Width deviation
Width
mm Deviation
mm
≤800 ±3
>800 -3~+5
4.3.3 For dyed fabric or printed fabric, the surface color difference, the color difference of the same batch and the color difference of the same roll shall not be lower than Grade 3 to 4.
4.3.4 For other defects, the buyer and the seller may reach an agreement on the scope and permitted limit of defects according to the purpose of the product.
5 Test methods
5.1 Determination of mass per unit area shall be carried out in accordance with GB/T 24218.1. The mass deviation rate per unit area shall be calculated using Equation (1), and the calculation result is accurate to one decimal place.
Foreword i
1 Scope
2 Normative references
3 Product classification
4 Technical requirements
5 Test methods
6 Inspection rules
7 Packaging, marking, storage and transportation
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 standard is developed in accordance with the rules given in GB/T 1.1-2009.
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 standard was proposed by China National Textile and Apparel Council.
This standard is under the jurisdiction of the National Technical Committee 209 on Textiles of the Standardization Administration of China (SAC/TC 209).
Textiles—Nonwoven fabrics for isolation gowns
1 Scope
This standard specifies the product classification, technical requirements, test methods, inspection rules, packaging, marking, storage and transportation of nonwoven fabrics for isolation gowns.
This standard is applicable to nonwoven fabrics for disposable isolation gowns worn by medical staff and visitors.
2 Normative references
The following referenced documents are indispensable for the application 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 250 Textiles—Tests for colour fastness—Grey scale for assessing change in colour
GB/T 4666 Textiles—Fabrics—Determination of width and length
GB/T 7742.1 Textiles—Bursting properties of fabrics—Part 1: Hydraulic method for determination of bursting strength and bursting distension
GB/T 12703.4 Textile—Evaluation for electrostatic properties—Part 4: Resistivity
GB/T 12704.1-2009 Textiles—Test method for water-vapour transmission of fabrics—Part 1: Desiccant method
GB 15979-2002 Hygienic standard for disposable sanitary products
GB 19082-2009 Technical requirements for single-use protective clothing for medical use
GB/T 24218.1 Textiles—Test methods for nonwovens—Part 1: Determination of mass per unit area
GB/T 24218.3 Textiles—Test methods for nonwovens—Part 3: Determination of tensile strength and elongation (strip method)
GB/T 24218.16 Textiles—Test methods for nonwovens—Part 16: Determination of resistance to penetration by water (hydrostatic pressure)
GB/T 24218.17 Textiles—Test methods for nonwovens—Part 17: Determination of resistance to penetration by water (spray impact)
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
3 Product classification
The nonwoven fabrics for isolation gowns are classified by their inherent quality requirements into Class I, Class II, Class III and Class IV with gradually increasing protective performance.
Notes: Class I refers to isolation gowns generally used for visitors, cleaners and other purposes.
Class II refers to isolation gowns generally used for routine care and examination.
Class III refers to isolation gowns generally used for occasions where patients have a certain amount of bleeding and liquid secretions.
Class IV refers to improved isolation gowns generally used for long-term or large-scale exposure to patients' blood, body fluids or clean medical waste.
4 Technical requirements
4.1 Inherent quality
The inherent quality of nonwoven fabrics for isolation gowns shall be in accordance with those specified in Table 1.
Table 1 Inherent quality requirements
Assessment item Performance indicator
Class I Class II Class III Class IV
Mass deviation rate per unit area
% ±6
Spray impact seepage
g ≤4.5 ≤1.0 ≤1.0 Not required
Hydrostatic pressure
kPa Not required ≥1.8
(18 cmH2O) ≥4.4
(45 cmH2O) ≥9.8
(100 cmH2O)
Resistance to microbial penetration Not required Not required Not required Acceptable a
Resistance to synthetic blood penetration
Level Not required Not required Not required ≥4
Bursting strength
kPa ≥40
Tensile strength
N ≥20 ≥20 ≥30 ≥45
Water-vapour permeability rate
g/(m2·24h) ≥3600
Antistatic property
(Surface resistivity)
Ω Not required ≤1×1012
a The resistance to microbial penetration is assessed in accordance with YY/T 0689-2008.
4.2 Microorganisms
The microbial indicator of nonwoven fabrics for isolation gowns shall be in accordance with those specified in Table 2.
Table 2 Requirements for microbial indicators
Item Requirement
Total bacterial count
CFU/g ≤150
Total number of fungal colonies
CFU/g ≤80
Coliform Not detected
Pathogenic pyogenic bacteria Not detected
Note: Pathogenic pyogenic bacteria refer to pseudomonas aeruginosa, staphylococcus aureus and streptococcus hemolyticus.
4.3 Appearance quality
4.3.1 The cloth shall be even and flat, and neatly wrapped, free of micropores and crystal points, obvious creases, broken edges and holes, oil stains and spots.
4.3.2 Width deviation shall be in accordance with those specified in Table 3.
Table 3 Width deviation
Width
mm Deviation
mm
≤800 ±3
>800 -3~+5
4.3.3 For dyed fabric or printed fabric, the surface color difference, the color difference of the same batch and the color difference of the same roll shall not be lower than Grade 3 to 4.
4.3.4 For other defects, the buyer and the seller may reach an agreement on the scope and permitted limit of defects according to the purpose of the product.
5 Test methods
5.1 Determination of mass per unit area shall be carried out in accordance with GB/T 24218.1. The mass deviation rate per unit area shall be calculated using Equation (1), and the calculation result is accurate to one decimal place.
Contents of GB/T 38462-2020
Foreword i
1 Scope
2 Normative references
3 Product classification
4 Technical requirements
5 Test methods
6 Inspection rules
7 Packaging, marking, storage and transportation
