YY/T 1628-2019 PDF English
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| YY/T 1628-2019 | English | 199 |
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Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
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YY/T 1628-2019: Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1628-2019
Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment
Plasticizedpolyvinylchloride(PVC)compoundsforinfusionandtransfusion
Equipmentsformedicaluse
Published on.2019-05-31
2019-09-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Shanghai New Shanghua Polymer Materials Co., Ltd., Yangzhou Kyle
Chemical Co., Ltd., Shenzhen Hengfangda Polymer Material Technology Co., Ltd., Jiangsu Yabang Tianlong Medical New Material Co., Ltd., Shandong Weigao Collection
Group Medical Polymer Products Co., Ltd., Shanghai Kangdelai Enterprise Development Group Co., Ltd.
The main drafters of this standard. Shi Yanping, Zhong Weiqin, Zhang Honghui, Liu Wanzong, Zhang Limei, Xu Longping, Xia Shoumin, Sheng Feng, Liu Aijuan, Li Weiyang,
Gao Yizhen.
introduction
Poly(ethylene chloride) (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is superior in processing properties and preserved in blood
It has advantages, and the price of polyvinyl chloride plastic for disposable medical devices is relatively low. Therefore, disposable medical batch plasticized with DEHP
There is still a vast market for consumables. The national standard GB/T 15593-1995 "soft polyvinyl chloride plastic for blood transfusion (liquid) appliances" can not meet
Disposable medical device products and market surveillance requirements, so before the national standards are revised, the industry standards are formulated to meet the requirements of the products.
Seek the need for market regulation.
In this standard, the requirements for raw materials have been added. In view of the wide variety of PVC additives in China, the production formulas of various production enterprises are also
Not all the same, it is impossible to give all the additive limits in the standard, but the changes in the formulation of the materials are regulated in the standard to prevent
Illegal addition of potentially harmful substances or unauthorized alteration of raw material formulations. Medical device supplementary test method "PVC infusion, blood transfusion apparatus
Identification and Quantitative Analysis of Fluorescent Substances is applicable to the detection of fluorescent whitening agents in PVC infusion transfusion devices. Industry standard YY/T 0926,
YY/T 0927 gives quantitative analysis and dissolution of di(2-ethylhexyl) phthalate (DEHP) in polyvinyl chloride medical devices.
Guide to measurement.
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment
1 Scope
This standard specifies the requirements, test methods, marking, packaging and storage of polyvinyl chloride (PVC) pellets for medical blood transfusion and infusion equipment.
This standard applies to PVC resin as the main body, di(2-ethyl)hexyl phthalate (DEHP) as plasticizer and epoxidized soybean oil.
Or PVC granules modified by blending additives such as epoxidized linseed oil.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Plastics -- Determination of tensile properties of plastics - Part 2. Test conditions for moulding and extruded plastics
GB/T 2411-2008 Plastic and hard rubber using a hardness tester to determine the indentation hardness (Shore hardness)
GB/T 2917.1-2002 Blends and products based on homopolymers and copolymers of vinyl chloride release hydrogen chloride and any of them at high temperatures
Determination of his acidic products Congo red method
GB/T 4615-2013 Determination of polyvinyl chloride residual vinyl chloride monomer - Gas chromatography
GB/T 6682 Analytical laboratory water specifications and test methods
GB 14232.1-2004 Human blood and blood components - Plastic containers - Part 1. Traditional blood bags
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 requirements
3.1 Material requirements
Raw materials used in the production of PVC pellets should be controlled, and no artificial additions have been included in the relevant regulations and directives, and no toxicological evaluation
Estimated substance. Any changes in the material formulation should be verified against the intended use and specified in the accompanying documentation.
3.2 Identification
According to the "People's Republic of China Pharmacopoeia" (2015 version) four 0402 infrared spectrophotometric determination, PVC pellet infrared spectrum should be
The map provided by the manufacturer is consistent.
3.3 Performance requirements
3.3.1 Appearance
Visual observation with normal or corrected visual acuity in natural light. PVC pellets should be uniform in color and transparent or translucent. Not allowed
Black spots and foreign impurities.
3.3.2 Physical and chemical properties
3.3.2.1 Physical properties
The physical properties of PVC pellets are to comply with the requirements of Table 1.
YY/T 1628-2019
Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment
Plasticizedpolyvinylchloride(PVC)compoundsforinfusionandtransfusion
Equipmentsformedicaluse
Published on.2019-05-31
2019-09-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Shanghai New Shanghua Polymer Materials Co., Ltd., Yangzhou Kyle
Chemical Co., Ltd., Shenzhen Hengfangda Polymer Material Technology Co., Ltd., Jiangsu Yabang Tianlong Medical New Material Co., Ltd., Shandong Weigao Collection
Group Medical Polymer Products Co., Ltd., Shanghai Kangdelai Enterprise Development Group Co., Ltd.
The main drafters of this standard. Shi Yanping, Zhong Weiqin, Zhang Honghui, Liu Wanzong, Zhang Limei, Xu Longping, Xia Shoumin, Sheng Feng, Liu Aijuan, Li Weiyang,
Gao Yizhen.
introduction
Poly(ethylene chloride) (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is superior in processing properties and preserved in blood
It has advantages, and the price of polyvinyl chloride plastic for disposable medical devices is relatively low. Therefore, disposable medical batch plasticized with DEHP
There is still a vast market for consumables. The national standard GB/T 15593-1995 "soft polyvinyl chloride plastic for blood transfusion (liquid) appliances" can not meet
Disposable medical device products and market surveillance requirements, so before the national standards are revised, the industry standards are formulated to meet the requirements of the products.
Seek the need for market regulation.
In this standard, the requirements for raw materials have been added. In view of the wide variety of PVC additives in China, the production formulas of various production enterprises are also
Not all the same, it is impossible to give all the additive limits in the standard, but the changes in the formulation of the materials are regulated in the standard to prevent
Illegal addition of potentially harmful substances or unauthorized alteration of raw material formulations. Medical device supplementary test method "PVC infusion, blood transfusion apparatus
Identification and Quantitative Analysis of Fluorescent Substances is applicable to the detection of fluorescent whitening agents in PVC infusion transfusion devices. Industry standard YY/T 0926,
YY/T 0927 gives quantitative analysis and dissolution of di(2-ethylhexyl) phthalate (DEHP) in polyvinyl chloride medical devices.
Guide to measurement.
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment
1 Scope
This standard specifies the requirements, test methods, marking, packaging and storage of polyvinyl chloride (PVC) pellets for medical blood transfusion and infusion equipment.
This standard applies to PVC resin as the main body, di(2-ethyl)hexyl phthalate (DEHP) as plasticizer and epoxidized soybean oil.
Or PVC granules modified by blending additives such as epoxidized linseed oil.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Plastics -- Determination of tensile properties of plastics - Part 2. Test conditions for moulding and extruded plastics
GB/T 2411-2008 Plastic and hard rubber using a hardness tester to determine the indentation hardness (Shore hardness)
GB/T 2917.1-2002 Blends and products based on homopolymers and copolymers of vinyl chloride release hydrogen chloride and any of them at high temperatures
Determination of his acidic products Congo red method
GB/T 4615-2013 Determination of polyvinyl chloride residual vinyl chloride monomer - Gas chromatography
GB/T 6682 Analytical laboratory water specifications and test methods
GB 14232.1-2004 Human blood and blood components - Plastic containers - Part 1. Traditional blood bags
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 requirements
3.1 Material requirements
Raw materials used in the production of PVC pellets should be controlled, and no artificial additions have been included in the relevant regulations and directives, and no toxicological evaluation
Estimated substance. Any changes in the material formulation should be verified against the intended use and specified in the accompanying documentation.
3.2 Identification
According to the "People's Republic of China Pharmacopoeia" (2015 version) four 0402 infrared spectrophotometric determination, PVC pellet infrared spectrum should be
The map provided by the manufacturer is consistent.
3.3 Performance requirements
3.3.1 Appearance
Visual observation with normal or corrected visual acuity in natural light. PVC pellets should be uniform in color and transparent or translucent. Not allowed
Black spots and foreign impurities.
3.3.2 Physical and chemical properties
3.3.2.1 Physical properties
The physical properties of PVC pellets are to comply with the requirements of Table 1.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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