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GB 10010-2009: [GB/T 10010-2009] Plasticized polyvinyl chloride (PVC) tubing for medical uses
Status: Valid GB 10010: Evolution and historical versions
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| GB 10010-2009 | English | 209 |
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[GB/T 10010-2009] Plasticized polyvinyl chloride (PVC) tubing for medical uses
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GB 10010-2009
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| GB 10010-1988 | English | 439 |
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Plasticized polyvinyl chloride (PVC) tubing for medical uses
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Basic data | Standard ID | GB 10010-2009 (GB10010-2009) | | Description (Translated English) | [GB/T 10010-2009] Plasticized polyvinyl chloride (PVC) tubing for medical uses | | Sector / Industry | National Standard | | Classification of Chinese Standard | G33 | | Classification of International Standard | 83.140.40; 11.040.30 | | Word Count Estimation | 8,824 | | Date of Issue | 2009-09-30 | | Date of Implementation | 2010-06-01 | | Older Standard (superseded by this standard) | GB 10010-1988 | | Quoted Standard | GB/T 191; GB/T 1040.2-2006; GB/T 2411; GB/T 2828.1-2003; GB/T 4615-2008; GB/T 14233.1-1998; GB/T 16886.1 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 10 of 2009 (No. 150 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies the requirements for medical soft PVC tubing, test methods, inspection rules, marking, packaging, transport and storage. This standard applies to PVC resin as the main raw materials in medical-related fields, for conveying fluid medium gas, liquid (such as blood, liquid, nutrition, waste liquids, etc.), Shore (A) Hard in the range of 40 to 90 PVC pipe (hereinafter referred to as pipes). | GB 10010-2009: [GB/T 10010-2009] Plasticized polyvinyl chloride (PVC) tubing for medical uses---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Plasticized polyvinyl chloride (PVC) tubing for medical uses
ICS 83.140.40; 11.040.30
G33
National Standards of People's Republic of China
Replacing GB 10010-1988
Medical soft polyvinyl chloride pipe
Published 2009-09-30
2010-06-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
3.4, 3.5 of this standard is mandatory, the rest are recommended.
This standard replaces GB 10010-1988 "soft PVC medical tubing."
This standard GB 10010-1988 The main difference is as follows.
--- Removed steam resistance, resistance to dry heat, low temperature performance, density, water absorption, hydrostatic testing, permanent deformation;
--- remove chemical properties of the ether-soluble extract zinc content.
This standard chemical properties of the pharmaceutical industry standard reference project YY1048-2007 "artificial heart-lung machine during cardiopulmonary bypass pipeline."
The standard proposed by China Light Industry Federation.
This standard by the National Standardization Technical Committee of plastic products.
This standard is drafted. Tianjin Plastics Research Institute.
Participated in the drafting of this standard. Kyle Yangzhou Chemical Co., Ltd., Guangdong Sheng Hengchang Chemical Industry Co., Ltd., Jiang Su Kaishou medical equipment
Limited.
The main drafters. Cao often, horsepower, Qiang Xuan, summer sleeve China, Luo Chong far, Heng Jianhua.
This standard supersedes the previous editions are.
--- GB 10010-1988.
Medical soft polyvinyl chloride pipe
Range 1
This standard specifies the requirements of soft PVC medical tubing, test methods, inspection rules, marking, packaging, transportation and storage.
This standard applies to a polyvinyl chloride resin as the main raw material, in the relevant medical art, --- for conveying a gas, a liquid (e.g., flowable medium
Blood, liquid, nutrient solution, liquid excreta, etc.), Shore (A) hardness in the range of 40 to 90 PVC pipe (hereinafter referred to as pipes).
2 Normative references
Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard
Whether the latest versions of these documents. For undated references, the latest version applies to this standard.
GB/T 191 Packaging Pictorial flag (GB/T 191-2008, ISO 780.1997, MOD)
GB /Plastics Determination of tensile properties T 1040.2-2006 Part 2. Test conditions for molding and extrusion plastics (ISO 527-2.
1993, IDT)
GB/T 2411 plastic and hard rubber hardness measured indentation hardness (Shore hardness) (GB/T 2411-2008, ISO 868.
2003, IDT)
GB/T 2828.1-2003 Sampling procedures - Part 1. Test batches by sampling the reception quality limit (the AQL) search
Plan (ISO 2859-1.1999, IDT)
GB/T 4615-2008 residual vinyl chloride monomer content by gas chromatography (ISO 6401. 1985,
NEQ)
GB/T 14233.1-1998 medical infusion, transfusion, injection equipment methods - Part 1. Method for chemical analysis
Biological Evaluation GB/T 16886.1 medical devices - Part 1. Evaluation and Testing (GB/T 16886.1-2001, idt ISO 10993-
1.1997)
3.1 Size
Pipe size specifications agreed upon by both parties, the limit deviation shall be as specified in Table 1.
Table 1 limit deviations pipe
Project limit deviation
Outside diameter
the inside diameter of
Wall thickness
± 15%
Length of ± 5%
Note. There are special requirements, agreed upon by both supply and demand.
3.2 Sensory
Plasticized tubing should be good, the same smell, no bubbles, no kink, deformation, the inner and outer wall should be smooth and clean, pollution-free.
3.3 Physical and mechanical properties
Physical and mechanical properties of the pipe should be in accordance with Table 2.
Table 2. Physical and Mechanical Properties
Item Index
Tensile strength/MPa ≥12.4
Tensile strain at break /% ≥300
Compression set /% ≤40
Shore (A) hardness N ± 3
NOTE. Different different Shore hardness pipe required, N is the nominal pipe Shore (A) hardness.
3.4 Chemical properties
3.4.1 reducing substances
The difference between the volume of the test liquid with the potassium permanganate solution 20mL same batch consumed blank solution [Ba (KMnO4) = 0.002mol/L] of
No more than 1.5mL.
3.4.2 heavy metal
The total content of heavy metals in the test liquid shall not exceed 1.0μg/mL, cadmium, tin should not be detected.
3.4.3 pH
Comparative test liquid and blank solution, the pH value of the difference may not exceed 1.0.
3.4.4 evaporation residue
50mL total evaporation residue test liquid should not exceed 2.0mg.
3.4.5 vinyl chloride monomer
Vinyl chloride monomer content should be less than 1.0μg/g.
3.5 biological properties
Biological properties of the pipe should meet the requirements of the appropriate biological evaluation of the country.
Test Method 4
4.1 Pipe Size and limit deviations
The outer diameter of the pipe, the inner diameter, wall thickness or projector using precision instruments to measure not less than 0.01mm, and the length is 1mm with indexing
Gage measurements.
4.2 Sensory
Check in indoor natural light.
4.3 Physical and mechanical properties
4.3.1 Environment for conditioning and testing
Sample shall be (23 ± 2) ℃, 45% relative humidity environment of 55% for at least 4h, and tested under these conditions.
4.3.2 tensile strength, tensile strain at break
8mm diameter is smaller than or equal to the pipe, the pipe taken directly to the test, the total length of the sample is 120mm, the effective length of 50mm; inner diameter
Pipe greater than 8mm, using GB/T 1040.2-2006 A. FIG. 5A specimen type 2; test speed of 100mm/min, the remaining press
GB/T 1040.2-2006 provisions.
4.3.3 Compression set
4.3.3.1 appliances
Splints, pads, not less than 0.02mm vernier caliper.
4.3.3.2 Sample
Sample groups of three sections, each 50mm.
4.3.3.3 Test procedure
The outer diameter of the measurement specimen, the specimen is clamped in the clamp pad having a thickness of one-half the outer diameter of the spacer is allowed to stand at 23 ℃ ± 2 ℃ environment
24h, remove the sample, placed IH, measuring the outer diameter direction of compression, calculated according to formula (1) compression set, the results were the best of the three samples
A large value, accurate to 0.1%.
Q = D0-D1D0 ×
100 (1)
Where.
Q --- compression set,%;
The outer diameter D0 --- pressure before the sample in millimeters (mm);
After compression direction Dl --- pressed sample diameter, in millimeters (mm).
4.3.4 Shore
4.3.4.1 Sample Preparation
After mixing pipe material or pulverized material in the mill and ℃ temperature of (165 ± 5) mixing plastic 5min ~ 10min, and then at a temperature of
(165 ± 5) ℃ hydraulic pressure in the press is not preheated, heated and pressurized, the pressing pressure of the order of cooling the mold 15min ~ 20min.
Test piece should be flat, the thickness is not less than 5mm.
4.3.4.2 Test procedure
Tested according to the provisions of GB/T 2411's.
4.4 Chemical properties
4.4.1 Preparation of test solution
A sample was cut into 1cm long segment, into a glass container, and outside the sample by the total surface area (cm2) and the ratio of water (mL) for 2/1
Example add water, capped, placed 24h at 37 ℃ ± 1 ℃, the sample was separated from the liquid, cooled to room temperature, as the test solution.
Take the same volume of water in a glass container, with the blank solution was prepared.
4.4.2 reducing substances
Tested according to the provisions of GB/T 14233.1-1998 in 5.2.2.
4.4.3 heavy metal
The total content of heavy metals tested according to the provisions of GB/T 14233.1-1998 in 5.6.1.
In determination of cadmium, tin inspection predetermined GB/T 14233.1-1998 in 5.9.1.
4.4.4 pH
Tested according to the provisions of GB/T 14233.1-1998 in 5.4.1.
4.4.5 evaporation residue
Tested according to the provisions of GB/T 14233.1-1998 in 5.5.
4.4.6 vinyl chloride monomer
Tested according to the provisions of GB/T 4615-2008's.
4.5 biological properties
Biological properties were evaluated according to the provisions GB/T 16886.1's.
5 Inspection Rules
5.1 Inspection Classification
5.1.1 factory inspection
Sensory factory inspection items, size, tensile strength, tensile strain, (A) Hardness, Shore chemical properties of the reducing substance,
The total content of heavy metals, pH.
5.1.2 Type inspection
Type test items 3.1 to 3.4, conduct a test every year under normal circumstances.
The following circumstances shall be type tested.
a) new products or old products to the plant when;
B) after formal production, such as raw materials, a larger change process, it may affect product performance;
c) Discontinued more than six months to restore production;
D) When the factory test results and the last type test results are quite different;
e) the national quality supervision agency made when required for type testing.
5.1.3 Biological performance test
Under normal circumstances biology test performance test once every four years.
One of the following circumstances should be tested biological properties.
a) new products or old products to the plant when;
B) after the official production, such as raw materials, processes are major changes, it may affect product performance.
5.2 Batching and Sampling
5.2.1 Batch
With the same materials, the same specifications of the formulation and production process, from the same batch as a pipe, each batch does not exceed 20000m,
When less than 20000m, continuous 7d pipe produced batch.
5.2.2 Sampling
Sensory, size press test GB/T 2828.1-2003 predetermined, normally checked using a sampling program, taking general inspection level
Ⅱ, reception quality limit (AQL) 4.0, Table 3 sampling plan. Physical and mechanical properties of the pipe, chemical and biological properties of the test, should be
Appearance, size inspection sample a sufficient number of random samples.
Table 3 sampling plan in meters
Batch range
The sample size
Receiving a number
Ac
Rejection number
Re
3 ~ 15301
16 to 25,501
26 to 50,812
51 ~ 901312
91 ~ 1502023
151 ~ 2803234
281 ~ 5005056
501 ~ 12008078
1201 ~ 32001251011
3201 ~ 100002001415
10001 ~ 350003152122
5.3 determine the rules
Sensory, size determined according to Table 3.
Test results Mechanical tubing physical and chemical properties, the items while if it failed, should double the original random sample batch of
The project re-inspection, re-inspection results are satisfactory, then this batch of qualified pipe. Biological properties of the pipe when the unqualified items, then this batch
Pipe failure.
6 signs, packaging, transportation and storage
6.1 mark
Each package bag should have inspection certificate, inspection date and code inspector.
It should be product specifications, quantity, nominal hardness, factory batch number, manufacturer name, trademarks and other marks on the inner bag products.
Shall be marked on the packaging of the product.
a) Product name, model number;
b) factory batch number;
c) production plant name and address;
d) gross weight;
e) Volume;
F) "Handle with care", "fear wet", "heat intolerance" and the like should meet the requirements shown signs GB/T 191 a.
6.2 Packaging
6.2.1 package
Polyethylene film product is appropriate for double-sealed packaging.
6.2.2 packaging
The packaging is appropriate carton, quality should not exceed 16kg.
6.3 Transport
When handling the product to be handled with care during transport should be sunscreen, anti-rain, anti-stress, and maintain the integrity of the packaging.
6.4 Storage
It should be placed in a cool, dry, well-ventilated, non-corrosive gases warehouse storage, away from walls and floor at least 200mm, storage
For one year.
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