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GB/T 15593-2020 PDF in English


GB/T 15593-2020 (GB/T15593-2020, GBT 15593-2020, GBT15593-2020)
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GB/T 15593-2020: PDF in English (GBT 15593-2020)

GB/T 15593-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 83.080.20
G 32
Replacing GB/T 15593-1995
Plasticized poly(vinyl chloride) compounds for
transfusion (infusion) equipment
ISSUED ON: NOVEMBER 19, 2020
IMPLEMENTED ON: OCTOBER 01, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Requirements ... 6 
3.1 Material requirements... 6 
3.2 Appearance ... 6 
3.3 Performance ... 6 
4 Inspection method ... 8 
4.1 Appearance ... 8 
4.2 Preparation of specimens ... 8 
4.3 Physical properties ... 9 
4.4 Chemical properties ... 10 
5 Marking, packaging, transportation, storage ... 12 
5.1 Marking ... 12 
5.2 Packaging ... 12 
5.3 Transportation ... 12 
5.4 Storage ... 12 
Appendix A (Informative) Information on non-phthalic plasticizer ... 13 
Appendix B (Informative) Recommended value of tensile properties of PVC
plastic ... 14 
Appendix C (Normative) Test method of water absorption ... 15 
References ... 17 
Plasticized poly(vinyl chloride) compounds for
transfusion (infusion) equipment
1 Scope
This standard specifies the requirements, test methods, markings, packaging,
transportation, storage of plasticized poly(vinyl chloride) compounds for
transfusion (infusion) equipment.
This standard applies to the PVC plastics for disposable transfusion (infusion)
bags, transfusion (infusion) catheters, accessories, which are made through
blending and modifying the main material of polyvinyl chloride resin, by adding
other necessary additives such as bis(2-ethylhexyl) phthalate (DEHP)
plasticizer, epoxy soybean oil and/or epoxy linseed oil.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) is applicable to this standard.
GB/T 1040.2-2006 Plastics - Determination of tensile properties - Part 2: Test
conditions for molding and extrusion plastics
GB/T 2411-2008 Plastics and ebonite - Determination of indentation
hardness by means of a durometer (shore hardness)
GB/T 2917.1 Determination of compounds and products based on vinyl
chloride homopolymers and copolymers to evolve hydrogen chloride and
any other acidic products at elevated temperatures - Congo red method
GB/T 4615 Poly (vinyl chloride) - Determination of residual vinyl chloride
monomer content - Gas chromatographic method
GB/T 5470-2008 Plastics - Determination of the brittleness temperature by
impact
GB/T 9345.5-2010 Plastics - Determination of ash - Part 5: Poly (vinyl
chloride)
GB 14232.1-2020 Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers
GB/T 14233.1-2008 Test methods for infusion transfusion injection
equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process
3 Requirements
3.1 Material requirements
It shall control the raw materials used in production. It shall not artificially add
the substances, that have been prohibited in the relevant regulations and
instructions AND have not been toxicologically evaluated. Any changes in the
material formula shall be approved by the user AND subject to related
verification.
Note: The recognition that bis(2-ethylhexyl) phthalate (DEHP) plasticizers have
reproductive toxicity risks is widely accepted. The application of non-DEHP
plasticized PVC plastics has become a trend. Pellets manufacturers and
medical device manufacturers should conduct risk assessments, on the safety
of materials and devices, based on their end use. For information about non-
phthalic plasticizers and non-phthalic PVC plastics, see Appendix A.
3.2 Appearance
It is in natural transparent or natural translucent particles, in uniform color,
without charred particles, foreign impurities. For special colors, it can be
determined, through negotiation between the user and the manufacturer.
3.3 Performance
3.3.1 Physical properties
The physical properties of PVC plastics shall meet the requirements of Table 1.
4.4 Chemical properties
4.4.1 Determination of the chemical properties of PVC plastic water-
soluble matter
4.4.1.1 Preparation of test solution for PVC plastic water-soluble matter
Take the uniform part of sheet specimen, which has a total surface area
(including the two surfaces of the plastic sheet) of 600 cm2 [when the sample is
PVC plastic for blood bags, the total surface area is 1200 cm2], AND a thickness
of (0.45 ± 0.05) mm. Use soapy water, tap water, laboratory grade 2 water to
wash it clean. Dry it naturally. Cut into pieces of 1 cm2. Then according to the
ratio of 2:1 between specimen (cm2) and water (mL) [for the PVC plastic for
blood bags, the ratio between specimen (cm2) and water (mL) is 6:1], immerse
in a 500 mL glass container. Use an appropriate method to seal it. Place it in a
pressure steam sterilizer. Extract for 20 minutes under saturated steam at (121
± 2) °C (for the PVC plastic sample for blood bags, extract for 30 min). After
heating, separate the sample from the liquid. Cool it to room temperature, as
the test solution. The water used for the preparation of the test solution shall be
laboratory grade 2 water.
4.4.1.2 Preparation of blank control solution
Use the same batch of laboratory grade 2 water, without adding the test piece,
to operate at the same time, to prepare a blank control solution.
4.4.1.3 Determination of reducing substances
It is performed according to the requirements for indirect titration of 5.2.2 in
GB/T 14233.1-2008.
4.4.1.4 Determination of pH
It is performed according to the requirements of 5.4.1 in GB/T 14233.1-2008.
4.4.1.5 Determination of color
Take 50 mL each of the test solution and the blank control solution. Respectively
place them in a Nessler colorimetric tube. Use a white object as a background.
Under a fluorescent lamp, use normal or corrected vision, to make comparison
observation with the blank control solution.
4.4.1.6 Determination of UV absorption
According to 5.7 of GB/T 14233.1-2008, within 5 h, use a 1 cm absorption cell,
to measure the peak value of the ultraviolet light absorption peak, in the
wavelength range of 230 nm ~ 360 nm.
4.4.1.7 Determination of evaporation residue
It is performed according to the requirements of 5.5 in GB/T 14233.1-2008. The
difference, between the mass of the residue of the extract and the blank control
solution, is expressed in milligrams.
4.4.1.8 Determination of zinc
It is performed according to the requirements of 5.9.2.1 in GB/T 14233.1-2008.
4.4.1.9 Determination of metals
4.4.1.9.1 Determination of barium (Ba), chromium (Cr), copper (Cu), lead
(Pb), tin (Sn), cadmium (Cd), aluminum (Al)
It is performed according to the requirements of 5.9.1 in GB/T 14233.1-2008.
4.4.1.9.2 Determination of mercury (Hg)
It is performed according to the requirements of 5.9.3 in GB/T 14233.1-2008.
4.4.1.10 Determination of the total amount of heavy metals (in Pb)
It is performed according to the requirements of Method 2 in 5.6 of GB/T
14233.1-2008. The chemical detection method of total heavy metal can be used
to replace atomic absorption spectroscopy.
4.4.2 Determination of ethanol extract (DEHP)
The specimen uses a 250 mL empty bag. It is performed according to the
requirements of A.4.10 in GB 14232.1-2020.
4.4.3 Determination of the chemical properties of PVC plastics
4.4.3.1 Determination of ash
Accurately weigh 2 g of sample, accurate to 0.1 mg. Make determination
according to the provisions of method B in GB/T 9345.5-2010.
4.4.3.2 Determination of vinyl chloride monomer
It is performed according to the requirements of GB/T 4615.
Appendix C
(Normative)
Test method of water absorption
C.1 Test sample
There are 10 specimens of 25 mm × 70 mm with straight edges, wherein 5
specimens are the test group, the other 5 specimens are the blank control group.
C.2 Test instrument
C.2.1 Analytical balance, which has an accuracy of 0.0001 g.
C.2.2 Constant temperature water bath, which has an accuracy of 0.5 °C.
C.2.3 Drying box, which has an accuracy of 1 °C.
C.2.4 Drying tank.
C.3 Test procedure
C.3.1 Cut 10 pieces of 25 mm × 70 mm specimens, with straight edges, wherein
5 specimens are the test group, the other 5 specimens are the blank control
group.
C.3.2 Wash the pieces with soapy water, normal water, laboratory grade 2 water
one by one. Use clean degreasing gauze and silk cloth to wipe off the surface
moisture and fibers.
C.3.3 Accurately weigh the total mass of the test group (A) and the blank control
group (B), accurate to 0.1 mg.
C.3.4 Use spiral stainless steel wire, to separate each specimen of the test
group, at an appropriate distance. Immerse the specimen in a constant
temperature water tank, which has reached the constant temperature of (50 ±
0.5) °C. Soak it for 2 h ± 20 s.
C.3.5 After taking out the specimen from the constant temperature water tank,
immediately put it into water at room temperature. Take it out after 5 min. Wipe
off the water. Accurately weigh it within 2 min ± 20 s (C), accurate to 0.1 mg.
C.3.6 Respectively spread the test group specimens and the blank control
group specimens, in a porcelain plate. Put it into a drying oven, which has
reached constant temperature of (80 ± 1) °C. Dry it for 2 h ± 20 s. Then take it
out. Cool it in a drying tank for 30 min. Accurately weigh the total mass of the
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.