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GB/T 21869-2008 English PDF (GBT21869-2008)

GB/T 21869-2008 English PDF (GBT21869-2008)

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GB/T 21869-2008: Medical gloves -- Determination of removable surface powder

GB/T 21869-2008
Medical gloves.Determination of removable surface powder
ICS 11.140
G45
National Standards of People's Republic of China
GB/T 21869-2008/ISO 21171..2006
Determination of residual powder on the surface of medical gloves
(ISO 21171..2006, IDT)
2008-05-14 released
2008-10-10 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Issued by China National Standardization Management Committee
Foreword
This standard is equivalent to the use of ISO 21171..2006 "Determination of residual powder on the surface of medical gloves" (English version). This standard is equivalent to translating ISO 21171..2006.
For ease of use, the following editorial changes have been made to this standard. a) The word "this International Standard" is changed to "this Standard"; b) Replace the comma "," as the decimal point with a decimal point ".". This standard was proposed by China Petroleum and Chemical Industry Association. This standard is provided by the Latex Products Sub-Technical Committee of the National Rubber and Rubber Products Standardization Technical Committee (SAC/TC35/SC4) Be in charge.
This standard was mainly drafted by. Jiangyin Jialewei Latex Products Co., Ltd., Beijing Medical Device Inspection Institute, Jiangyin Entry-Exit Inspection and Inspection Epidemiological Bureau, Zhuzhou Rubber Plastics Industry Research and Design Institute of China Rubber Group. The main drafters of this standard. Xu Yongping, Yue Weihua, Mao Jiehong, Zhang Yu, Deng Yizhi. This standard is issued for the first time.
GB/T 21869-2008/ISO 21171..2006
ISO Foreword
The International Organization for Standardization (ISO ) is a worldwide joint body of national standards bodies (ISO member bodies). International standards The work is usually carried out by the ISO technical committee, and any member group interested in the project that has established a technical committee has the right to participate in the committee Yes, governmental or non-governmental international organizations associated with ISO can also participate in this work. In all work of electrotechnical standardization, ISO cooperates closely with the International Electrotechnical Commission (IEC ). This International Standard was drafted in accordance with the provisions of Part 2 of the ISO /IEC Guidelines. The main task of the technical committee is to develop international standards. The draft international standards adopted by the technical committee shall be distributed to the member groups for investment When a vote is issued as an international standard, at least 75% of member groups are required to vote in favour. Attention should be paid to the possibility that certain parts of this document are the subject of patent rights. ISO does not recognize any or all patent rights. responsibility.
The international standard ISO 21171 is divided into technical committees for raw materials for rubber industry (including latex) by the Technical Committee of Rubber and Rubber Products (ISO /T C45/SC3).
This international standard is subject to the permission of ASTM, and is based on ASTM D6124..2001 "Standard for the Determination of Residual Powder on the Surface of Medical Gloves" Made for the foundation.
For the purpose of this International Standard, the CEN appendix on meeting European Commission regulations has been deleted. GB/T 21869-2008/ISO 21171..2006
Determination of residual powder on the surface of medical gloves
Warning --- users of this standard should be familiar with general laboratory operations. This standard does not involve any security issues, even if it is related to it Is no exception, users should establish corresponding safety and health regulations, and make them comply with national regulations. 1 Scope
This standard specifies the determination method for the easily removable powder content on the surface of medical rubber gloves. Method A applies to "powdered" gloves, method B And method C applies to "powder-free" gloves. This standard does not involve safety issues related to the powder on the surface of the glove, nor does it specify the residual surface of the glove I powder limit. Medical gloves not made of rubber are not applicable to this standard. 2 Principle
First wash the water-insoluble powder on the surface of the gloves with water, and then use the method of filtration and weighing to determine. Number of gloves used in the test It depends on whether it has powder or not.
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Under the test conditions, all water-insoluble substances that can be removed by washing with water on the surface of the glove. 3.2
In order to make it easy to wear, the powder coating process is usually added in the production process, and the gloves with the trademark "powder" are manufactured. 3.3
Manufacture gloves marked as "powder-free".
Note. Gloves should usually be clearly marked with powder or without powder (glove not marked is generally not accepted by consumers), if the sample of gloves does not contain "powder" or "Pink free", the glove should be regarded as having powder gloves.
4 Equipment and instruments
Commonly used glassware and tweezers in the laboratory and the following equipment. 4.1 Balance. Accuracy 0.1mg
4.2 Mechanical oscillator. The minimum oscillation frequency is 1.7 Hz (102 times/min) 4.3 Oven. can keep the temperature at 100 ℃ ± 5 ℃
4.4 Suction filter. It consists of microporous glass fiber filter membranes with a diameter of 90mm and 47mm and a pore size of 2.7μm and a suction filter device. 4.5 Dryer.
5 Reagents
Distilled or deionized water.
6 Sampling
From each batch of products to be tested, randomly select an appropriate number of samples. There are 2 powder gloves during the measurement; 5 powder-free gloves, including surgical hands GB/T 21869-2008/ISO 21171..2006
3 pairs of surgical gloves (ie 6).
7 Method A --- Test steps for powdered gloves
7.1 Before testing, clean all glassware and tweezers with water.
7.2 Under the condition that the test temperature is 25 ℃ ± 5 ℃, randomly select 2 samples for testing. 7.3 Place a microporous glass fiber filter with a diameter of 90 mm and a pore size of 2.7 μm in a desiccator to dry for at least 30 min, and remove the filter Note. Experience shows that there is a risk of damage when the filter is removed from the glass surface. It is recommended to use polytetrafluoroethylene (PTFE) as the substrate. 7.4 Place the filter membrane in the suction filter.
7.5 Carefully remove the glove from the packaging bag and place it in an Erlenmeyer flask with a capacity of 1L or other suitable container. 500ml of water to make the glove sleeve edge 1cm ~ 3cm above the bottle mouth, then add 250ml of water to the glove, use tweezers to hold a small part of the hand Set the sleeve edge away from the conical bottle mouth, let the air in the conical bottle exhaust, ensure that the added water can be flushed to the part of the glove sleeve edge that is higher than the bottle mouth, Seal the top of the conical bottle with a rubber stopper wrapped with a polypropylene film to avoid leakage. Move the sealed Erlenmeyer flask to the mechanical shaker, Oscillate at a frequency of not less than 1.7 Hz for 30 seconds to ensure that the entire surface of the glove is completely cleaned. 7.6 Remove the Erlenmeyer flask from the shaker, remove the stopper, pour the water in the glove into the suction filter containing the filter membrane, take out the glove, put the glove inside The remaining water and the water in the Erlenmeyer flask are poured into the suction filter containing the filter membrane. 7.7 Add 500mL of water to the Erlenmeyer flask, put the same glove into the Erlenmeyer flask, add 250mL of water to the glove, press 7.5 and 7.6 Repeat the test.
7.8 Repeat the operation of 7.7 more than two times, so that each glove is washed with water more than 4 times. The stopper covers the membrane to ensure that all attachments on the glove surface can be transferred to the filter membrane. 7.9 Repeat the test for the other glove according to 7.5 to 7.8 (if it is a surgical glove, use the other one in the same pair). 7.10 Drain the water in the filter membrane as much as possible by suction filtration, discard the filtrate, and carefully remove the filter membrane. Place the filter on the washed and dried Place the watch glass or porcelain dish in an oven at a temperature of 100 ° C ± 5 ° C for 1 hour, and then move it to a desiccator to cool it for at least 30 minutes. In order to minimize moisture absorption, after removing the filter membrane from the dryer, it should be weighed immediately with a balance, accurate to 0.1 mg, and the quality is recorded in units of g. 8 Result calculation (Method A)
(1)
9 Method B and Method C --- "powder-free" glove test procedure
9.1 Overview
In general, the test procedure for determining powder in powder-free gloves is similar to that described above (see Chapter 7). But the ones used for testing powder-free gloves The size of the filter membrane is small, except for the number of samples of surgical gloves (see note), the number of samples of gloves is 5, and the amount of water used to wash each glove is relatively with. Since only a small amount of powder remains on the surface of powder-free gloves, it is necessary to conduct a blank test. Note. When packing surgical gloves, the pair is the packaging unit. Since the left and right hands in a pair of gloves are not usually produced at the same time, determine the left and right hands The same number of gloves is important.
9.2 Method B --- Non-surgical procedures for "powder-free" gloves
9.2.1 Before testing, clean all glassware and tweezers with water.
9.2.2 Randomly select 5 samples to test at 25 ℃ ± 5 ℃.
9.2.3 Place a microporous glass fiber filter with a diameter of 47mm and a pore size of 2.7μm in the suction filter, and first use three 50mL water GB/T 21869-2008/ISO 21171..2006
Rinse the filter, and then drain the filter. After moving the filter membrane into the watch glass, put it in an oven with a temperature of 100 ℃ ± 5 ℃ and dry it for 1h. Then move it to a desiccator to cool it for at least 30min, take out the filter membrane and immediately weigh it with a balance, accurate to 0.1mg, with g as the unit, record Note. Experience shows that there is a risk of damage when the filter is removed from the glass surface. It is recommended to use polytetrafluoroethylene (PTFE) as the substrate. 9.2.4 Place the weighed filter membrane in the suction filter.
9.2.5 Carefully remove the glove from the packaging bag and place it in a Erlenmeyer flask with a capacity of 1L or other suitable container. 500ml of water to make the glove sleeve edge 1cm ~ 3cm above the bottle mouth, add 250ml water into the glove, use tweezers to clamp a small part of the glove sleeve Let it leave the bottle mouth, let the air in the conical bottle be discharged, ensure that the water added to the glove can be flushed to the part of the glove sleeve that is higher than the mouth of the bottle A polypropylene stopper with a polypropylene film seals the conical bottle to avoid leakage. Move the sealed Erlenmeyer flask to the mechanical shaker Oscillate at a frequency of 1.7 Hz for 30 s to ensure that the entire surface of the glove is completely cleaned. 9.2.6 Remove the Erlenmeyer flask from the shaker, open the stopper, and pour the water in the glove into a 600mL beaker. From the Erlenmeyer flask Remove the glove and pour the remaining water in the glove into the beaker. Discard gloves. If the water in the Erlenmeyer flask is poured out accidentally during the operation, add water to the Erlenmeyer flask to keep the water in the Erlenmeyer flask at 500mL about.
9.2.7 With another glove, repeat the test according to 9.2.5 and 9.2.6. Put the glove into an Erlenmeyer flask with 500mL of water In, pour the water in the 600mL beaker into the glove.
9.2.8 Perform the third glove test according to 9.2.5 and 9.2.6 until the fifth. 9.2.9 Pour the water in the beaker into the weighed filter membrane, remove the glove from the Erlenmeyer flask, pour the remaining water in the glove into the filter membrane, and finally pour Remove the water from the Erlenmeyer flask, rinse the beaker, Erlenmeyer flask and stopper film with water to ensure that all the powder left on the surface of the gloves (5 pieces) is transferred to On the membrane.
9.2.10 Use the suction filter to drain the water in the filter membrane as much as possible, and discard the filtrate. Carefully remove the filter membrane with tweezers, move it to wash and dry In a watch glass or porcelain dish, put it in an oven with a temperature of 100 ℃ ± 5 ℃ for 1 hour, and then move the watch glass to a desiccator for cooling at least 30min, in order to minimize moisture absorption, after removing the filter from the dryer, it should be weighed immediately with a balance, accurate to 0.1mg, in g units, 9.3 Blank sample test
Use the same conical flask, stopper, polypropylene film, suction filter and beaker as in 9.2.3 and 9.2.4, and determine the quality of the filter membrane according to 9.2.3 9.4 Calculation of results (Method B)
9.5 Method C --- "powder-free" surgical gloves test procedure
Except for the different number of gloves, the test procedure is the same as Method B. 9.5.1 Before testing, clean all glassware and tweezers with water.
9.5.2 Randomly select 3 pairs of samples to test at 25 ℃ ± 5 ℃.
9.5.3 Place a microporous glass fiber filter with a diameter of 47mm and a pore size of 2.7μm in the suction filter, flush with 3 pieces of 50mL water Wash the filter membrane, then drain the water from the filter membrane. After moving the filter membrane to a watch glass or porcelain dish, put it in an oven with a temperature of 100 ℃ ± 5 ℃ to dry it After 1h, move it to a desiccator to cool it for at least 30min. After removing the filter, it should be weighed immediately with a balance, accurate to 0.1mg, with g as Note. Experience shows that there is a risk of damage when the filter is removed from the glass surface. It is recommended to use polytetrafluoroethylene (PTFE) as the substrate. 9.5.4 Place the weighed filter membrane in the suction filter.
9.5.5 Carefully remove the glove from the packaging bag and insert it into an Erlenmeyer flask with a capacity of 1L or other suitable container. 500ml of water to make the glove sleeve edge 1cm ~ 3cm above the bottle mouth, add 250ml water into the glove, use tweezers to clamp a small part of the glove sleeve GB/T 21869-2008/ISO 21171..2006
Let it leave the bottle mouth, let the air in the conical bottle be discharged, ensure that the water added to the glove can be flushed to the part of the glove sleeve that is higher than the mouth of the bottle A polypropylene stopper with a polypropylene film seals the conical bottle to avoid leakage. Move the Erlenmeyer flask to the mechanical oscillator so that it is not less than 1.7 Hz The frequency is oscillated for 30s to ensure that the entire surface of the glove is completely cleaned. 9.5.6 Remove the Erlenmeyer flask from the shaker, open the stopper, and pour the water in the glove into a 600mL beaker. If the water in the Erlenmeyer flask is poured out accidentally during the operation, add water to the Erlenmeyer flask to keep the water in the Erlenmeyer flask at about 500mL. 9.5.7 With another pair of gloves, repeat the test according to 9.5.5 and 9.5.6. Put the glove into the remaining 500mL In a conical flask of water, pour the water in the 600mL beaker into the glove. 9.5.8 With another 4 (or 2 pairs) gloves, repeat the test according to 9.5.5 and 9.5.6 until the sixth. 9.5.9 Pour the water in the beaker into the weighed filter membrane, remove the glove from the Erlenmeyer flask, pour the remaining water in the glove into the filter membrane, and finally pour Remove the water from the Erlenmeyer flask, rinse the beaker, Erlenmeyer flask and stopper film with water to ensure that all the powder left on the surface of the gloves (6 pieces) is transferred to On the membrane.
9.5.10 Use a suction filter to drain the water in the filter membrane as much as possible, and discard the filtrate. Carefully remove the filter membrane with tweezers, move it to wash and dry Put the watch glass or porcelain dish into an oven with a temperature of 100 ℃ ± 5 ℃ and dry for 1h. Move the watch glass or porcelain dish to a desiccator for cooling at least 30min, in order to minimize moisture absorption, after removing the filter from the dryer, it should be weighed immediately, accurate to 0.1mg, with g as the unit, and record its quality 9.6 Blank test
Using the same conical flask, stopper, polypropylene film, suction filter and beaker as in 9.5.3 and 9.5.4, determine the quality of the filter membrane according to 9.5.3 9.7 Calculation of results (Method C)
10 Precision
10.1 The precision and bias clauses have been formulated according to the technical report ISO /T R92272 related to terminology and other statistical details. 10.2 The precision rules in this precision and deviation clause give the following details for specifying the materials used in the laboratory project Estimation of the precision of the test method. In addition to the documents providing special materials and specified tests where the precision parameters apply to these test methods, The precision parameter cannot be applied to the acceptance/rejection test of any material. 10.3 The precision of Type A 1 was measured in.2005. The period of both repeatability and reproducibility tests was short, and the repeat test was obtained within 10 days. Test results, the average of the test results, as described in this test method, obtained two test values or measured values of the performance or parameters. 10.4 Four types of powder gloves, three types of powder-free gloves and one type of powder-free surgical gloves were used in Method A, Method B and Method C in 13 experiments A comparison test was conducted between the rooms.
10.0.5 For the test method A of powdered gloves, perform 3 sets of parallel tests with 2 gloves of each type. 10.6 For powder-free inspection gloves Test Method B, a group of parallel tests is performed with 5 gloves for each type. 10.7 For test method C of powder-free surgical gloves, a set of parallel tests is performed with 6 gloves (3 pairs). 10.8 Repeatability and reproducibility of precision calculation results are shown in Table 1, Table 2 and Table 3, according to the average amount of powder for each type of gloves from large to small arrangement.
The closest average level to any given material at any given time in a standard test. 10.11 Reproducibility. The reproducibility R in this test method can be determined by the values in Table 1 and Table 2, according to the two GB/T 21869-2008/ISO 21171..2006
When the difference between the independent test result and the R value in the list is large, it is considered to be due to the totality of different samples. 10.13 Bias. In test method terminology, bias is the difference between the test average and the characteristic value (or true value) of the benchmark test, because This test method specifies the test characteristic values. For this test, there is no reference value, so the bias cannot be measured. Table 1 Method A-Powdered gloves
Glove type
average value/
mg
In-lab laboratory room
1. Natural latex examination gloves with powder 180 7 19 19 10 15 43 24 2. Natural latex surgical gloves with powder 117 10 28 28 14 14 3...

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