supplyMedical protective clothing

Technical requirements for medical disposable protective clothing

1 Range

This standard specifies the requirements, test methods, marking, instructions for use, packaging and storage of disposable medical protective clothing

This standard is applicable to medical disposable protective clothing (hereinafter referred to as protective clothing) that provides barrier and protection for medical personnel to contact with potentially infectious patients' blood, body fluids, parts, and airborne particles during work.

2 Standard reference files

The provisions of the following documents become provisions of this Standard by reference to this Standard, and all subsequent amendments (excluding omissions) or revisions to dated references are not applicable to this Standard. However, parties to an agreement under this Standard are encouraged to study the availability of the most recent version of these documents, which applies to references of illegal dates In this standard

GB/T191 packaging storage and transportation icon (GBT191-2008,1S0780,1997,MOD)

Fabric tensile properties of fine fabrics - Part 1- Determination of breaking strength and breaking secondary length by strip method

GBT474-1997 Determination of impermeability of young woven fabrics hydrostatic test (eqSO81191)

GBT4745-1997 Determination of surface moisture resistance of textile fabrics risk of water exposure (eqv IsO49201981)

GBT5455-1997 Vertical method of textile combustion performance test

GBT5549-1990 Determination of surface tension of surfactants by pulling up liquid film method

GBT12703-1991 Method for electrostatic test of young fabrics

GBT12704-1991 Determination of moisture permeability of fabrics -- moisture cup method

Test methods for medical infusion and blood transfusion injection apparatus - Part 1: chemical analysis methods

GBT142331-2005 Test methods for medical infusion and blood transfusion injection apparatus - Part 2 Biological test methods

GB159792002 Hygienic standard for disposable sanitary products

Biological evaluation of medical devices-Part 10: Stimulation and delayed hypersensitivity test

So1099310:2002,DT)

1sT40.201) Standard test method for electrostatic attenuation of non-woven fabrics

3 Terms and definitions

The following terms and definitions apply to this standard

3.1

Particulate matter

A solid, coated, or granular substance suspended in air, such as microorganisms, dust, smoke, and fog

3.2

Filtration efficiency "itering efriciency

The percentage of particulate matter removed from the air by protective clothing under specified conditions

3.2

Synthetic blood synthetie bloo

A synthetic liquid night body equivalent to the surface tension and viscosity of blood for testing purposes

3.4

protective clothin's critieal an

The right and left thrusts, arms and back positions of the protective clothing

3.5

Electrostatic dectrostatle decay

When grounded, the material has the ability to eliminate the electrical charge induced to the surface of the material

3.6

decay time Decay time

The time, in seconds, required for the induced charge to decay to 10% of its initial level

4 Requirements

4.1 Appearance

4.1.1 The protective clothing should be dry, clean and free of mold, and the surface should not have adhesion, cracks, holes and other defects

4.1.2 The connecting parts of the protective clothing can be stitched, bonded or hot bonded. The needle eyes should be sealed, the needle distance should be 8 to 14 stitches every 3cm, and the stitches should be uniform and straight. The parts after bonding or hot sealing should be flat and sealed without bubbles

4.1.3 The zipper of protective clothing equipped with zippers should not be exposed, and the pull head should be self-locking

4.2 Structure

4.2.1 The protective clothing consists of a hooded jacket and pants, which can be divided into a one-body structure and a two-body structure. See FIG. 1 and FIG. 2 respectively for the structures of the one-body and two-body types

4.2.2 The structure of protective clothing should be reasonable, easy to wear and take off, and tight

4.2.3 Elastic closing shall be applied to the cuffs and feet, and elastic closing rope or buckle shall be applied to the face and waist of the hat

Type 4.3 Specifications

Types of protective clothing are divided into 160, 165, 170, 175180, 185, type specifications are shown in Table 1 and Table 2

4.4 Liquid barrier function

4.4.1 Water resistance

The hydrostatic pressure of the key parts of the protective clothing should not be less than 1.67kPa(17cmH1O).

4.4.2 Moisture permeability

The moisture permeability of protective clothing material shall not be less than 2500g/(m3,d)

4.4.3 Resistance to synthetic blood penetration

The resistance of protective clothing to synthetic blood penetration should not be lower than the requirements of level 2 in Table 3

4.4.4 Surface temperature resistance

The water level of the outer side of the protective clothing should not be lower than the requirement of level 3

4.5 Break morning alliance force

The breaking strength of materials in key parts of protective clothing should not be less than 45N

4.6 Elongation of broken eye

The elongation at break of the key parts of the protective clothing material should not be less than 15%

4.7 Filtration Efficiency

The filtration efficiency of non-oily particles at the key parts of protective clothing materials and joints should not be less than 70%

4.8 Resistance performance

Protective clothing with flame retardant performance shall meet the following requirements:

8) Damage length is not more than 200mm

b) The subsequent burning time shall not exceed 15s

c) Smoldering time does not exceed 10s

49 Antistatic property

The charge of protective clothing should not be greater than 0. 6pC/ piece

4.10 Electrostatic attenuation performance

The electrostatic attenuation time of the protective clothing material shall not exceed 0.5s

411 Skin Irritation

The primary stimulus score should not exceed 1

4.12 Microbial Specifications

4.12.1 Protective clothing should meet the requirements of GB15979-2002 for biological indicators, as shown in Table 4

4.12.2 Protective clothing marked "sterile" or "sterile" or illustrated on the package shall be sterile

Table 4 Microbial indicators of protective clothing

4.13 Residual ethylene oxide

The residual amount of ethylene oxide in protective clothing sterilized by ethylene oxide should not exceed 10pB/g

5 Test methods

5.1 Appearance

1.1 Visual inspection shall comply with the requirements of 4.1.1

5.1.2 For visual inspection, needle distance shall be measured with a universal measuring tool, which shall comply with the requirements of 4.1.2.

5.1.3 Pull the lock of each protective suit sample for 5 times, and test 3 pieces, all of which shall meet the requirements of 4.1.3.

5.2 Structure

Visual inspection shall meet the requirements of 4,2

Type 53 specifications

Use a universal measuring tool to measure the sample of each type of protective clothing, determine 3 pieces, and their specifications should meet the requirements of 4,3

5.4 Liquid barrier function

5.4.1 Impermeability

demand

The key parts of the protective clothing shall be sampled in accordance with the hydrostatic test specified in GB/T4744-1997, and the results shall conform to 4.4.1

5.42 Residual temperature

The test results of the protective clothing materials shall comply with the requirements of 4.4.2 in accordance with the method A temperature absorption method specified in GB/T12704-1991

54.3 Resistance to synthetic blood puncture

The test results of the protective clothing materials in accordance with Appendix A shall comply with the requirements of 4.43

5.4.4 Surface moisture resistance

The outer side of the protective clothing material shall be carried out in accordance with the moisture test specified in GB/T4745-1997, and the results shall meet the requirements of 4.4.4.

5.5 Breaking Strength

The material of the key parts of the protective clothing shall be tested according to the strip method specified in GB/T3923.1-1997, and the drill nut shall meet the requirements of 4.5

56 elongation in the morning

The material of the key parts of the protective clothing shall be tested according to the strip method specified in GB/T3923.1-1997, and the results shall meet the requirements of 4.6.

5.7 Filtration Efficiency

The results of at least 3 samples of protective clothing tested should meet the requirements of 4.7.

Sodium chloride aerosol or similar solid air soluble should be used in an environment with a relative humidity of 30% to 10% and a temperature of 25C±5C

Glue [median number of grains diameter (CMD)10.075gm±0.020ym standard deviation of particle distribution;≤1.86; concentration

≤200mg/m3] For the test, the air flow rate is set to 15L/min±2L/min, and the cross-sectional area of the air flow is 100cm2

58 Flame retardant properties

The material of protective clothing shall be tested in accordance with the vertical method specified in GB/T5455-1997, and the results shall meet the requirements of 4.8

5.9 Antistatic property

Test results in accordance with the method specified in 7.2 of GB/T12703-1991 shall meet the requirements of 4.9.

5.10 Electrostatic attenuation performance

510.1 Test Environment

Before the test, the samples were placed at a relative humidity of 50%±3% and a temperature of 23 ° C to 1 ° C for 24h, and the test was also conducted under this condition

proceed

5.10.2 Sampling

Take a sample of 89mm×(1526)mm at each key part of the protective suit. Take care to wear latex or

5.10.3 Testing

Install the test sample in accordance with lsT40.2(01) on an electrostatic attenuation measuring instrument capable of generating at least plus or minus 5000 voltage.

Then apply 5000V voltage to the material, and then measure the charge decay time. The decay time of the 5 test samples should be in line with 4.10

demand

5.11 Skin irritation

5.11.1 Extraction medium

0.9% sodium chloride injection

5.11.2 Preparation of the extract

Under unconditional conditions, two samples of 2.5cm×2.5cm were cut from the protective clothing, and the extraction medium was added at the ratio of 1mL/cm2

Extraction at 37℃ for 72h. The extraction medium without the tested sample was prepared by the same method as the negative control solution.

5.11.3 Testing