YY/T 1642-2019 English PDF (YYT1642-2019)

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YY/T 1642-2019: Single-use medical protective hood
YY/T 1642-2019
Single-use medical protective hood
ICS 11.120
C48
People's Republic of China Pharmaceutical Industry Standard
Disposable medical protective cap
Published on July 24,.2019
2021-02-01 implementation
Published by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Inspection Institute.
This standard was drafted. Beijing Medical Device Inspection Institute, Wenjian Medical Supplies Co., Ltd.
The main drafters of this standard. Jin Guosheng, Yue Weihua, Hu Guangyong, Wang Huan, Liu Min, Zhang Yaping, Liu Simin, Zhang Juan, Pan Sichun, Ran Qi.
Disposable medical protective cap
1 Scope
This standard specifies the technical requirements, test methods, signs and instructions for use and packaging and storage of disposable medical protective caps.
This standard applies to medical staff, disease control and epidemic prevention workers who wear disposable messengers when exposed to potentially infectious pollutants.
Use a medical protective cap (hereinafter referred to as a protective cap). Refer to this standard for limited use medical protective caps.
This standard does not apply to medical radiation protection caps, disposable medical caps and disposable surgical caps.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 2410-2008 Determination of light transmittance and haze of transparent plastics
GB/T 3923.1-2013 Textile fabrics. Tensile properties. Part 1. Determination of breaking strength and elongation at break (strip
law)
GB/T 4744 Testing and Evaluation of Waterproofing Performance of Textiles
GB/T 4745 Testing and Evaluation of Textile Waterproofing Performance
GB/T 5455-2014 Determination of vertical burning length, smoldering and afterglow time of burning behavior of textiles
GB/T 12704.1-2009 Test method for moisture permeability of textile fabrics. Part 1. Hygroscopic method
GB/T 14233.1-2008 Test methods for medical infusions, blood transfusions and syringes-Part 1. Methods for chemical analysis
GB 15979-2002 Hygienic standard for disposable sanitary products
GB 19082-2009 technical requirements for medical disposable protective clothing
Pharmacopoeia of the People's Republic of China (2015 edition) four
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Luminoustransmittance
The ratio of the luminous flux transmitted through a transparent or translucent sample to its incident luminous flux is expressed as a percentage.
3.2
Haze
The ratio of the scattered light flux to the transmitted light flux transmitted through a transparent or translucent sample and deviating from the direction of incident light, expressed as a percentage (for this
For the method, only the scattered light flux above 2.5 ° from the incident light direction is used to calculate the haze).
3.3
Protects heads, faces and necks of medical personnel, disease control and epidemic prevention workers from direct contact with potentially infectious contaminants
A class of medical protective products for dyes.
4 Technical requirements
4.1 Structure and specifications
4.1.1 Structure
The structural design of the protective cap should be reasonable and not affect the normal use of the wearer.
4.1.2 Specifications
The protective cap should include (but not limited to) a protective cap covering the head and neck and a transparent eye window. Specifications of protective caps and goggles
An example is shown in Figure 1. L1, L2, H1, and H2 should meet the design dimensions and tolerances of the product identification.
In centimeters
Figure 1 Example of the size of protective caps and eye pieces
4.2 Appearance
4.2.1 Appearance of protective cap
The appearance of the protective cap should meet the following requirements.
a) The protective cap body should be clean and free of mildew spots, and the surface must be free from defects such as cracks and damage;
b) Eye protection must not have perforations and air bubbles, water lines, streaks, violent tendons, fish-eye stiffness and plasticizing defects that obstruct the wearer's sight;
c) The sponge strip (if any) should be soft, and it should be closely adhered to the eye piece; the hook and loop surfaces of the hook and loop (if any) should be firmly adhered, and the peeling force should be
Not less than 5N; the release paper (if any) on the double-sided tape should adhere well.
4.2.2 Protective cap cover connection part
The seams of the protective caps should be firmly connected, and the joints can be processed by stitching, heat sealing or bonding; if the stitching is processed, the joints
The eye of the needle should be handled tightly, the stitch length of the suture should meet 8 stitches/3cm ~ 14 stitches/3cm, the stitching stitch code should be straight and uniform, and there should be no jumping needle
For bonding or gluing, the joints should be flat, sealed and free of air bubbles.
4.2.3 Eye protection
Protective caps with eye pieces, the eye pieces and the material of the cap body should be tight, firm and not detached.
4.3 Performance
4.3.1 Impermeability
The hydrostatic pressure of the main body of the protective cap and the seam should not be less than 1.67kPa (17cmH2O).
4.3.2 Moisture permeability
The moisture permeability of the main material of the protective cap should not be less than 2500g/(m2 · 24h).
4.3.3 Surface moisture resistance
The level of water on the outer surface of the main body of the protective cap should not be less than level 3.
4.3.4 Resistance to synthetic blood penetration
The synthetic blood penetration resistance of the main body of the protective cap and the joints shall not be less than the requirements of level 2 in Table 1.
Table 1 Classification of anti-synthetic blood penetrability
Level pressure value/kPa
3 3.5
2 1.75
1 0a
a indicates that the pressure on the material is only the pressure produced by synthetic blood in the test tank.
4.3.5 Filtration efficiency
The filtering efficiency of the protective cap material and the joints of the finished product for non-oily particles should not be less than 70%.
4.3.6 Antistatic
The charged amount of the protective cap should not be greater than 0.6 μC/piece.
4.3.7 Electrostatic attenuation performance
The static decay time of the main material of the protective cap should not exceed 0.5s.
4.3.8 Breaking strength
The breaking strength of the main body of the protective cap should not be less than 40N.
4.3.9 Elongation at break
The elongation at break of the main body of the protective cap should not be less than 15%.
4.4 Light transmittance and haze
4.4.1 Light transmittance
The protective film's transmittance to visible light should not be less than 90%.
4.4.2 Haze
Eye protection should be ≤ 4%.
4.5 Flame retardant properties
The flame retardant performance of the protective cap material should meet the following requirements.
a) the damage length is not more than.200mm;
b) the afterburning time does not exceed 15s;
c) The smoldering time does not exceed 10s.
4.6 Microbiological indicators
4.6.1 The microbiological index of non-sterile protective caps shall meet the requirements of Table 2.
Table 2 Microbiological indicators of protective caps
Total bacterial colonies
CFU/g
Coliform bacteria Pseudomonas aeruginosa Staphylococcus hemolytic streptococcus
Total fungal colonies
CFU/g
≤200 Not detectable Not detectable Not detectable Not detectable ≤100
4.6.2 The protective cap marked "sterilized" or "sterile" on the package or illustrated shall be sterile.
4.7 Residual ethylene oxide
Ethylene oxide sterilized protective caps should have an ethylene oxide residue of no more than 10 μg/g.
5 Test method
5.1 Structure and specifications
Take 3 samples and measure with a universal measuring instrument. The results should meet the requirements of 4.1.
5.2 Appearance
5.2.1 Appearance of protective cap
Protective cap cover and eye protection (if any), take 3 samples and visually inspect under natural light, and the results should meet 4.2.1a) and b)
Requirements.
Take 3 samples, and visually observe the bonding between the sponge strip (if any) and the eye protection sheet, which should be tightly bonded without gaps or detachment.
The loop surface and hook surface of each sample hook and loop tape are tightly bonded, the loop surface end is clamped and fixed, and the tensile test machine is used at a tensile speed of 300 mm/min
The hook surface end should be peeled off, the peeling length should be at least 60mm, and the maximum load during the peeling process should be taken. The results should meet the requirements of 4.2.1c).
Take 3 samples and visually inspect the release paper (if any) on the double-sided tape, which should be tightly bonded without gaps or detachment.
5.2.2 Protective cap cover body connection part
Take 3 samples and measure the needle pitch with a universal measuring instrument. Each sample measures the needle pitch at 3 different points. All results should meet the requirements of 4.2.2.
Claim.
5.2.3 Eye protection window (if any)
Take 3 samples and inspect them visually. The results should meet the requirements of 4.2.3.
5.3 Performance
5.3.1 Impermeability
Test according to the method of GB/T 4744, the results should meet the requirements of 4.3.1.
5.3.2 Moisture permeability
The material of the protective cap is tested in accordance with the method A hygroscopic method specified in GB/T 12704.1-2009, and the results should meet the requirements of 4.3.2.
5.3.3 Surface moisture resistance
The outer side of the protective cap material is tested in accordance with the water test specified in GB/T 4745, and the results should meet the requirements of 4.3.3.
5.3.4 Resistance to synthetic blood penetration
Tested according to GB 19082-2009 Appendix A, the results should meet the requirements of 4.3.4.
5.3.5 Filtration efficiency
Test at least 3 protective cap samples, and filter the protective cap body and seams according to the method of 5.7 in GB 19082-2009
The determinations were made separately and the results should meet the requirements of 4.3.5.
5.3.6 Antistatic
The test was conducted in accordance with the method specified in 5.9 of GB 19082-2009, and the results should meet the requirements of 4.3.6.
5.3.7 Static attenuation performance
5.3.7.1 Test environment
Before testing the samples, place them in an environment with relative humidity of 50% ± 3% and temperature of 23 ℃ ± 1 ℃ for 24h. Testing is also under this condition
get on.
5.3.7.2 Sampling
Take a sample with a size of 89mm × (152 ± 6) mm on the protective cap sample. Wear latex or cotton during sampling
Knit gloves to prevent contamination of the sample surface.
5.3.7.3 Test
According to the method of GB 19082-2009, install the test sample in an electrostatic attenuation measuring instrument that can generate a voltage of at least ± 5000V
Voltage, then apply 5000V voltage to the material, and then measure the charge decay time. The decay time of the 5 test samples should all meet the requirements of 4.3.7.
Claim.
5.3.8 Breaking strength
The protective cap material is tested in accordance with the strip method specified in GB/T 3923.1-2013. If the protective cap is a plastic material, the test gauge shall be
Set to 50mm, the results should meet the requirements of 4.3.8.
5.3.9 Elongation at break
The protective cap material is tested in accordance with the strip method specified in GB/T 3923.1-2013. If the protective cap is a plastic material, the test gauge shall be
Set to 50mm, the results should meet the requirements of 4.3.9.
5.4 Light transmittance and haze
The test is performed according to the provisions of GB/T 2410-2008, and the results should meet the requirements of 4.4.
5.5 Flame retardant properties
The protective cap material is subjected to the combustion performance test in accordance with the vertical method specified in Condition A in GB/T 5455-2014, and the results should meet the 4.5
Claim.
5.6 Microbiological indicators
5.6.1 Perform the test according to the method specified in Appendix B of GB 15979-2002, and the results should meet the requirements of 4.6.1;
5.6.2 Sterilized or sterile protective caps
This method is used for testing, and the results should meet the requirements of 4.6.2.
5.7 Residual ethylene oxide
The test was performed in accordance with the gas chromatography method specified in Chapter 9 of GB/T 14233.1-2008, and the results should meet the requirements of 4.7.
6 Signs and instructions
6.1 Signs
6.1.1 Marking of protective cap single package
The protective cap single package should have at least the following information.
a) Product name and model;
b) design specifications and tolerances;
c) the name of the manufacturer or supplier;
d) implementation of the standard number or product technical requirements number;
e) product registration number;
f) It should be marked with the words “Please refer to the instructions before use” or relevant safety warning information;
g) storage conditions and period of validity;
h) production date or batch number;
i) If there is a corresponding sterilization mark for sterilized products, the sterilization method and the sterilization period should be indicated;
j) "Single use" or related symbols should be marked.
6.1.2 Marking of the packing box
The protective cap box should have at least the following information.
a) Product name and model;
b) the name and address of the manufacturer or supplier;
c) implementation of the standard number or product technical requirements number;
d) prod...