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GB/T 38014-2019 English PDF (GBT38014-2019)

GB/T 38014-2019 English PDF (GBT38014-2019)

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GB/T 38014-2019: Textiles -- Protective nonwoven fabrics for surgical use

This Standard specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, packaging, marking, storage and transportation of protective nonwoven fabrics for surgical use. This Standard applies to single-layer non-woven fabrics, composite non-woven fabrics, film-coated non-woven fabrics that are used in surgical gowns, clean air suits and surgical drapes.
GB/T 38014-2019
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 59.080.30
W 59
Textiles - Protective nonwoven fabrics for surgical use
ISSUED ON: AUGUST 30, 2019
IMPLEMENTED ON: MARCH 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of the PEOPLE Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Product classification ... 6
5 Technical requirements ... 6
6 Test methods ... 8
7 Inspection rules ... 10
8 Packaging, marking, storage and transportation ... 11
Textiles - Protective nonwoven fabrics for surgical use
1 Scope
This Standard specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, packaging, marking, storage and transportation of protective nonwoven fabrics for surgical use. This Standard applies to single-layer non-woven fabrics, composite non-woven fabrics, film-coated non-woven fabrics that are used in surgical gowns, clean air suits and surgical drapes.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 250, Textiles - Tests for colour fastness - Grey scale for assessing change in colour
GB/T 3920, Textiles - Tests for colour fastness - Colour fastness to rubbing 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, Hygienic standard for disposable sanitary products
GB 18401-2010, National general safety technical code for textile products GB/T 24120, Textiles - Determination of resistance to water/alcohol solution 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 24218.10, Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
GB/T 24218.16, Textiles - Test methods for nonwovens - Part 16:
Determination of resistance to penetration by water (hydrostatic pressure) YY/T 0506.2-2016, Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2: Performance requirements and test methods
YY/T 0506.5, Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 5: Test method for resistance to dry microbial penetration
YY/T 0506.6, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 6: Test method to determine the resistance to wet bacterial penetration
YY/T 0506.7, Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 7: Test methods for determination of cleanliness- microbial
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1 Standard performance surgical gowns (drapes)
Surgical gowns (drapes) that meets the minimum performance requirements during traumatic surgery.
3.2 High performance surgical gowns (drapes)
Surgical gowns (drapes) that meet the stricter performance requirements during traumatic surgery.
Note: During surgery, those who are expected to be over-exposed to fluids, mechanical stress, or longer surgical operation should use high
performance surgical gowns (drapes).
6.4 The determination of cleanliness (particulate matter) shall be carried out in accordance with GB/T 24218.10; the calculation shall be carried out in
accordance with A.3 of YY/T 0506.2-2016.
6.5 The determination of lint shall be carried out in accordance with GB/T 24218.10.
6.6 The determination of hydrostatic pressure shall be carried out in accordance with GB/T 24218.16; the rate of rise of water pressure shall be (10 ?? 0.5) cmH2O/min.
6.7 The determination of bursting strength shall be carried out in accordance with GB/T 7742.1.
6.8 The determination of breaking force shall be carried out in accordance with GB/T 24218.3.
6.9 The determination of resistance to alcohol penetration shall be carried out in accordance with GB/T 24120.
6.10 The determination of water-vapor transmission shall be carried out in accordance with the condition a) in Chapter 7 of GB/T 12704.1-2009.
6.11 The determination of color fastness to rubbing shall be carried out in accordance with GB/T 3920.
6.12 The determination of odor shall be carried out in accordance with 6.7 in GB 18401-2010.
6.13 The determination of cleanliness-microbial shall be carried out in accordance with YY/T 0506.7.
6.14 The determination of coliform bacteria and pathogenic pyogenic bacteria shall be carried out in accordance with GB 15979.
6.15 The determination of electrostatic properties (surface resistivity) shall be carried out in accordance with GB/T 12703.4.
6.16 The chromatic aberration is evaluated according to GB/T 250.
6.17 The fabric width is determined according to GB/T 4666.
6.18 The inspection of appearance defects is mainly based on the front of the product. The inspection shall be carried out on a horizontal inspection table; it shall use normal daylight northern light or fluorescent lighting; the table illumination is not less than 750 lx; the distance between the eyes and the table is about 60 cm.

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