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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 in...
Get QUOTATION in 1-minute: Click GB/T 21869-2008
Historical versions: GB/T 21869-2008
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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 in...
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