This standard specifies the requirements, test methods, marking, instructions for use, packaging, transportation and storage of disposable medical protective clothing. This standard applies to disposable medical protective clothing that provides barrier and protection for potentially infectious patient blood, body fluids, secretions, etc. that clinical medical staff come into contact with during work. GB 19082-2003 Technical Requirements for Disposable Medical Protective Clothing GB19082-2003 Standard Download Decompression Password: www.bzxz.net

4.2.4.3, 4.6.4.8 of this standard are recommended items, and their items are strong puncture items. This standard is used to evaluate the quality of medical disposable protective eyewear. GB19082-2003
This standard is a revised version of the standard published online on April 25, 203 (numbered GH19082-30K03>, and replaces the standard published online above.
Section A of this standard is a normative section,
This standard is issued by the National Drug Supervision and Administration Commission. This standard is under the jurisdiction of Beijing Medical Device Testing Center. The drafting unit of this standard: Beijing Medical Device Inspection Sub-Center. This standard 1 Scope
Technical requirements for medical disposable protective clothing
GB190822003
This standard specifies the requirements for medical disposable protective clothing, including testing methods, marking, instructions for use, packaging, transportation and treatment. This standard is applicable to the provision of protective clothing for clinical medical personnel who are exposed to infectious blood, body fluids, secretions, etc. of patients at work. 2 Normative references
The following clauses become clauses of this standard through reference to this standard: For any expired referenced document, all its subsequent amendments (excluding incorrect documents) or downgraded versions shall be used in this standard. However, the latest versions of these documents shall apply to any undated referenced document. GB/T191 Pictorial marking of packaging method
GB/T3923.11S97 Fabric tensile test Part 1: Determination of tensile strength and elongation at break
GR/2744—1997
Determination of water permeability of textile fabrics Determination of hydrostatic pressure GB/T4745-1999T
Water resistance test for textile fabrics GH/T $455-1$97
Test method for combustion performance of anti-corrosion products
GR/T 12703
GB/T 1270-—1931
Test method for electrical conductivity of textiles
Test method for moisture permeability of composite materials--solution method--wet cup method
GB/T14233.2:1993 Inspection method for medical infusion, injection and syringe--Part 2: Biological test methods GB 1557G2002
G1980—1995
Disposable quick-use sanitary products
Hygiene standard for disposable medical products
GB/T16886.=0.-2000Biological evaluation of medical products Part 10: Irritation and sensitization tests 1750-198Combustible substances
3 Terms and definitions
The following terms and definitions apply to this standard. 3.
Water repellency grade
spreyraeg
The degree of moisture permeability of fabrics.
|Water permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability water vapor permeability rate is the mass of water vapor passing through a unit area of ​​a substance within a specified time under the condition of constant water vapor on the surface of the substrate, expressed as g/(m2, d) under the given conditions.
[GB/12702—199,2 meter language!
irrltathon
is a local symptom reaction caused by one, multiple or continuous contact with the test material that does not involve an immunological mechanism168,10—20 minutes3.3
19082—2003
sterilizationAtion
uses physical or chemical methods to kill all microorganisms on the medium, rendering it sterile, [GB 15980—1935. definition3.1]
breakingForce
the amount of force applied to the test material during the stretch test under specified conditions. [GB/T3923.1—1997, definition 3.7]
Elongation at break is the elongation smaller than the breaking strength.
[GR/3S23.I—1997. definition & 3.11
Filtration efficiency
The percentage of particulate matter in the air removed by the protective product under the specified conditions, 3. 8
Ignition performance Lamelleardatlon
The protective product has the performance of self-ignition and dual combustion. [GB/T12903—1999], definition 2, 2.12]
4 Requirements
4.1 Appearance
4.1.1 The protective eyewear should be dry, strong, without cracks, and the surface enzyme should not have defects such as spots, cracks, etc. 4.1.2 The stitches should be glued or hemmed, and the stitch length Acm should be 8~11 stitches. The thread penetration should be even and smooth, and no stitches should be skipped.
4.1.3 If the protective clothing has a zipper, the zipper should be self-locking and cannot be exposed. .2 Structure
4.2.1 The protective clothing consists of a one-piece garment and a body part, which can be divided into a one-piece structure and a two-piece structure. 4.2.2 The structure of the protective clothing is reasonable, easy to put on and take off, and the joints are tight. 4.2.3 The drawstrings are elastic: the half-face and the drawstrings are elastic, drawstring or buckle. 4.3 Size
The maximum size of the protective clothing is 16, 165, 170, 175, 8, 1, and the size is shown in Table 1 and Table 2. The unit is tt|| 4.4 Liquid barrier function tt|| 4.4.1 Anti-water skiing performance tt|| Top length tt|| Table 2 Size of the main model tt|| When the static water pressure is 1.67k1a (17cmH, 0>, the protective clothing shall not be exposed to water 4.4.2 Moisture permeability tt|| The protective clothing shall not be less than 2500g/(m\:l), 4.4.3 Synthetic blood penetration tt|| The protective clothing shall not be less than the second level requirement in Table 3. Table 3 Anti-synthetic blood penetration level tt|| indicates the positive force generated by the combination or blood in the pressure test of the material, 4.4.4 Surface Moisture resistance
Test pressure/kPa
The water level of the protective surface should not be lower than the requirements of Grade 3 in G/T4745-1997. 4.5 Breaking force
The breaking strength of the protective clothing sample should not be less than 45N, 4.6 Breaking elongation
The breaking elongation of the protective clothing sample should not be less than 31%. 4.7
Over-efficiency test
The over-efficiency of the anti-expansion drive for non-extractive particles should not be less than 7U%. 4.8 Catalytic performance
The anti-expansion drive with flame retardant performance should meet the requirements of Grade B of R1751-1D98. 4.9 Antistatic property
The charge of the protective clothing should not be less than 0.6.
4. 10 Skin irritation
Protective clothing should be made of materials without skin irritation. GHF9082—2003
Unit: centimeters
200~105
05~116
:10~115
=15180
120~126
CE19082—2003
4.11 Biological indicators
4.11.1 Protective clothing should meet the requirements of microbiological indicators in H15979—2002, see Table 14.11.2 Protective clothing with "killer" or "no" on the packaging should be Table 4 Microbiological indicators of protective clothing
Total number of bacterial colonies clu/)
Daxin Haiqun
Buhuishan
4.12 Ethylene oxide residue and
Great detectionbzxZ.net
Not detectable
Blood, etc.
Not detectable
For protective clothing sterilized with ethylene oxide, the ethylene oxide residue should not exceed 10g/4.13 Marking and instructions for use
Marking and instructions for use should meet the requirements of 6.1.1 and 6.2. 5 Test method
5.1 Appearance
5.1, 1 day inspection, should meet the requirements of 4.-.1. 5.1.2 Use the measuring tool to measure, the seat shall meet the requirements of 4.2. 5.1.3 Pull and close the collar of each protective clothing product 5 times, and all shall meet the requirements of 4.1.3. 5.2 Structure
Monthly inspection skin meets the requirements of 4.2,
5.3 Type
Total number of true south south falls/(efz>
Use the universal measuring tool to measure each type of protective clothing sample, the tool bias shall meet the requirements of 4.3, 5.4 Liquid resistance 5.4.1 Water resistance The hydrostatic pressure test specified in GB/T4744 shall be carried out, and the result shall meet the requirements of 4.1.1. 5.4.2 Liquid resistance The test shall be carried out in accordance with the test specified in GB/T12702, and the result shall meet the requirements of 4.4.2. 5.4.3 Synthetic blood penetration The test shall be carried out according to Appendix A, and the result shall meet the requirements of 4.4.3. 5.4.4 Surface moisture resistance The test shall be carried out in accordance with the test specified in GB/T4745, and the result shall meet the requirements of 4.4.4. 5.5 Breaking strength
Test with the strip method specified in GH/T3923.1, and the result should meet the requirements of 4.5.6 Breaking elongation
Test with the strip method specified in GB/T3923.1, and the result should meet the requirements of 1.5.7 Pollution efficiency
Test at least 3 protective stock samples, and the results and sensitivity meet the requirements of 4.7. Use chlorinated gas or similar solid gas in an environment with a relative humidity of 30 ± 10% and a blue degree of 25°C. Particle diameter (CMD): 0.0 7=4m10.220m weighing number has the difference of the previous geometric standard value, 1.86: spirit: 2m0mg for testing, air intake is set at 15Imin2/airflow area 1em.5.8 Flame retardant performance
According to (I3/T5455 is now directly determined into the heat energy test. The result should meet the requirements of 4, 8.) Air dynamic A>.2m0.06m
5.9 Antistatic property
According to the method specified in 7.2 of GB/T12703-1991, the test should meet the requirements of 4.S. 5.10 Skin irritation
GB 19DB2——2003
Test according to the method specified in 5.2 of GB/T16886.10-2000, and the results shall meet the requirements of 1.10: 5.11 Biological indicators
5.11.1 Test the protective limit sample according to the method specified in Appendix 2 of GB/T15979-2002. The results shall meet the requirements of 1.11.1.
5.11.2 Test according to the method specified in GB/T14233.2-1993, and the results shall meet the requirements of 4.11.2. 5.12 Ethylene oxide is registered according to the method specified in Appendix G of GB15980-1995, and the results shall meet the requirements of 4.12. 5.13 Marking, use Instructions
Check all items and they shall meet the requirements of 4.13. 6 Marking, instructions for use
6.1 Marking
6.1.1 The smallest packaging of eye protection should have the following clear and recognizable signs. If the packaging is transparent, the following signs can be marked:
a) Product name;
b) Name of manufacturer or supplier:
> Product number
d) Execution mark number:
Product registration number:
If it is a sterilized product, the expiration date of the sterilization should be indicated;
"Single use" or equivalent,
Date of production;
Storage conditions;
"Read instructions for use before use" or equivalent words. 6. 1.2 The protective clothing packaging box shall have at least the following signs: a) Product name: Name of the manufacturer or supplier, Product model: Execution label number: Product registration number: Packing quantity "one-time use" or "single use", Production date! 5) Special features: "sun protection", "wet protection", etc. words and signs. 6. 2 Instructions for use
6.2.1 Each protective clothing package should be accompanied by a set of instructions for use: 6.2.2 The instructions for use should be in Chinese at least.
6.2.3 The instructions for use should be complete and may use corresponding drawings. E.2.4 The instructions for use should at least include the following:
$B19082—2003
Product name;
Manufacturer name, contact number:
Product use and restrictions on use
Implementation standard number;
Product registration number;
Flame retardant level if applicable;
User requirements Inspection,
List of models,
Usage:
Purchase parts+
The meaning of the symbols and or> indicated;
Precautions.
Packaging, transportation and storage
7.1 Packaging
7.1.1 The packaging and storage and transportation diagrams shall comply with the requirements of GB/T191, 7.1.2 The packaging used for protection shall be equipped with a rack that can prevent mechanical damage and dirt before use. 7.1.3 The packaging box shall be accompanied by instructions for use and product inspection certificates, 7.2 Avoid fines
According to the joint regulations.
7. 3 Storage
According to the use period.
A.1 Specification
Appendix A
(Normative Appendix)
Test method for penetration of synthetic blood
GB19082—2003
This test adopts synthetic blood to determine the resistance of protective clothing to penetration of synthetic blood under different levels of test bed pressure. This test method is formulated with reference to ASTMF1570,1998. 4.2 Principle
The protective clothing material is tested with synthetic blood under continuous applied pressure, and the penetration of the synthetic blood on the material is visually inspected. 4.3 Resistors
The instruments of the test institute are as follows:
) A penetration test grid as shown in Figure A.1 and Figure A.2, preferably made of different materials, h) A square metal blocking screen, which shall meet the following requirements: open space>50%;
|Smra at 14kPu
c) A gas source that can provide 14kPa+1k pressure d) Stopwatch or electronic stopwatch, sugar content = 1s1 Analytical balance, box deer is 20.01R:
Clamps that can produce 13.3Nm torque;
g) Surface tension meter.
A.4 Reagents
Prepare 1L of synthetic blood according to the following formula: Methyl cellulose Sodium (CMC9004-32-4 - medium viscosity) 20% sodium chloride (analytical grade) methylisothiazole (MIT) fluorescein (15-57-3) 15-57-3) 10% sodium chloride (analytical grade ... The result should be (0.012 ± 0.002) N/m. If it exceeds this value, do not use it. A, 5 Test sample accuracy
Cut out 75mm×75mm test samples
Randomly or under other conditions, take 3 test samples from each protective clothing sample for test. 7
GE19082—2003
When testing composite materials or multi-layer materials, they should be tested at the right side of the media after extinguishing the south. A.6 Test procedure A.6.1 Assemble the test belt as follows: Place the test belt horizontally on the test bench, and place the protective clothing material on the belt surface and toward the test pin: b) Place the gasket, the resistance belt, and the cover on the test belt, and tighten the penetration test;
: The penetration test is installed in the test device with a vertical support, and the discharge net is lowered: d) The frequency of the test groove is slowly controlled to 13.5Nme) Close the discharge valve.
4.6.2 Use a deep bucket or syringe to measure the large amount of 50 4.6.3 If synthetic blood is not observed to penetrate the test area, add air to the test area and increase the pressure to 1P from the upper part of the test area. Keep the pressure at 5°C to see if the liquid penetrates. If synthetic blood is not observed to penetrate the test area, stop the test. 4.6.4 If synthetic blood is not observed to penetrate the test area, add air to the test area and increase the pressure to 1P from the upper part of the test area. Keep the pressure at 5°C to see if the liquid penetrates. If synthetic blood is not observed to penetrate the test area, stop the test. The test suitability of the sample is 1A.6.4 If no synthetic blood is observed to penetrate, the pressure will be gradually increased to 3.5 kPa and maintained at this pressure for 5 minutes. If there is no penetration of synthetic blood from the test sample, the test is stopped. If no synthetic blood is observed to penetrate the sieve, the pressure of the sample is slowly increased to 7 kPa and maintained at this pressure for 2 minutes. Observe whether there is any penetration of the sample on the visible surface. If there is any penetration or penetration by the test sample, the blood test is resumed. The sample's resistance to synthetic blood penetration is Grade S.
A6.E If no synthetic blood penetration is observed, the pressure is slowly increased to 14 kPa and maintained at this pressure for 5 minutes. Observe whether there is any penetration of the sample on the visible surface. If only synthetic blood is present in the test sample, the test is resumed. The sample's resistance to synthetic blood penetration is Grade 4.
.E.7: If synthetic blood is detected, slowly increase the pressure by 20 kPa and maintain this pressure for 5 minutes. Observe the visible surface of the sample to see if there is any reduction in the amount of blood. If synthetic blood is detected, the test is terminated. The sample is resistant to synthetic blood and the test is resistant to synthetic blood. If no synthetic blood is detected, the sample is resistant to synthetic blood and the test is resistant to synthetic blood. A6. After the test is completed, close the gas source and open the valve to prevent the test from leaking. A.6, 9. Open the discharge valve to remove the residual traces of synthetic blood and flush the test area with appropriate flushing method. Remove the sample and the test area from the test area. Clean the parts where the outside of the test belt comes into contact with synthetic blood. A.7 Test report The test report should include the following: Description of the test materials and sampling method:) Test results of each test sample at each level of force, test intensity, description difference: Resistance belt construction, test product: 8 and use TTFE whole material; however, test whole ticket ：
Figure A1 Test phase structure
GA190B2—2003
CB19082—2003
Central rent:
Pressure network device:
One gas supply period:
Ground test file;
One type test phase
Stirring excitement.
Figure A2 Test instrument slow display
Competition special skin
GE19032—2003
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