ICS 83.140.40; 11.040.30 
G33; C31 
 
 GGBB  
The National Standards of the People’s Republic of China 
 
 GB 10010 –xxxx 
To replace GB 10010–1988 
 
 
 
Plasticized polyvinyl chloride (PVC) tubing for medical uses 
  
 
  
 
(Approval Draft) 
 
 
  
 
   
 
 
 
Released on xx-xx-200x     Implemented on xx-xx-200x 
Released by:  
General Administration of Quality, Inspectio n and Quarantine of the People’s Republic 
of China 
Standardization Administration of  the People’s Republic of China  GB xxxx__xxxx 
 
 I    
 
Foreword 
 
Clauses 3.4 and 3.5 of the present standard are mandatory .  
The present standard revi ses Standard GB 10010-1988 Plasticized Polyvinyl Chloride 
(PVC) Tubing for Medical Uses .  
The main differences of the present st andard and Standard GB 10010-1988 are as 
follows: 
--- It deletes steam resistance, drought and heat resistance, low temperature 
performance, density, water absorbency rate, hydraulic pressure test and compression set;  
--- It deletes concentration of zinc and ether soluble extract in the chemical properties. 
The items of chemical properties listed in th e present standard are a result of reference 
to the Medical Industry’s Standard YY 1048—2007 Artificial Heart-Lung Cardiopulmonary 
Bypass Pipeline . 
The present standard is proposed by Ch ina National Light In dustry Council.  
The present standard is centrally mana ged by The National Technical Committee on 
Plastic Products for the Standard ization Administration of China. 
Tianjin Plastic Research Institute was re sponsible by the drafting of the present 
standard.  
The following institutions are involved in  the drafting process: Yangzhou Kai’er 
Chemical Co. Ltd., Guangdong Shenghengchang Ch emical Industry Co., Ltd. and Jiangsu 
Kaishou Medical Equipments Co., Ltd.  
The present standard is mainly drafted by: CAO Changzai, MA  Li, QIANG Xuan, XIA 
Xiumin, LUO Chongyuan and HENG Jianhua.  
Previous version of the pres ent standard includes: GB 10010—1988.   GB xxxx__xxxx 
 
 1 
Plasticized polyvinyl chloride (PVC) tubing for medical uses 
 
1 Scope 
 
The present standard specif ies the requirements, testi ng methods, testing rules, 
packaging, symbols, transportation and storag e for Plasticized polyvinyl chloride (PVC) 
tubing for medical uses. 
The present standard applies to PVC tubes mainly made of polyvinyl chloride resin, 
made for the purpose of carrying fluids like ga s, liquid (e.g. blood, medical solution, nutrient 
solution, fluid excrement and so on) in a medi cal setting and of a Shore (A) hardness of 
between 40 to 90.  
 
2 Normative quoted documents 
 
The clauses in the following documents ar e quoted and adopted as clauses in the 
present standard. For documents with a date that may have future amendment lists or an 
amended version, the amendments will not apply to  the present standard. However, all parties 
involved in any agreement reached based on the pr esent standard are enc ouraged to discuss if 
the latest revised edition of the documents are to  be adopted. As for documents without dates, 
their latest version will apply to the present standard.  
GB 191 Packaging and Tr ansportation Symbols (ISO 780:1997, EQV)  
GB/T 1040.2-2006 Plastic: the Testing of its  Tensile Property, Section 2: Testing 
Conditions for Melted Plastic and Pressed Plastic (ISO 527-2:1993, IDT)  
GB/T 2411-1998 Testing Methods for Plastic Shore Hardness GB/T 2828.1-2003 Numeration Sampling Testin g Procedure, Section 1: Per Batch 
Testing Sampling Plan based on AQL (ISO 2859-1:1999, IDT)  
GB/T 2918-1998 Standard Environment for Ad justing and Testing Plastic Sampling 
Conditions (ISO 291:1997, IDT)  
GB/T 4615-1984 Detection Method for Chlori de Monomer Residue in Polyvinyl 
Chloride Resin 
GB/T 14233.1-1998 Medical Infusi on, Blood Transfusion, Injection Equipment Testing 
Methods, Section 1: Chem ical Analysis Method  
GB/T 16886.1 Biological Evaluation of Medi cal Devices, Section 1: Evaluation and 
Testing (ISO 10993-1:1997, IDT)  
 
3 Requirements 
 
3.1 Size specification 
 The size of the tubes is to be negotia ted by the supplier and the buyer. Deviation  
limits must be in line with spec ifications listed in Table 1.  
Table 1 Deviation Limits for PVC Tubes 
Item Deviation Limit 
Outside diameter 
Inside diameter  
±15% GB/T xxxx__xxxx 
 2 Wall thickness 
Length  ±5% 
 Note: Special requirements are to be ne gotiated between the s upplier and the buyer.  
3.2 Visual inspection  
The tubes should have been plasticized pr operly, with no odour, no air bubbles, no kinks, 
no deformation. Both the inside and the outside  of the tube walls should be smooth, clean 
and free from contamination.  
3.3 Physical and mechanical properties 
The physical and mechanical properties of the tubes must meet the cr iteria as specified 
in Table 2.  
Table 2 Physical and Mechanical Properties of PVC Tubes 
Item Criteria 
Tensile strength MPa  ≥12.4 
Rupture tensile strain % ≥300 
Compression set % ≤40 
Shore (A) hardness N±3 
Note: Different tubes have di fferent requirements for Shore hardness, N is the Shore (A) 
hardness of a particular  brand of tubes.  
3.4 Chemical properties 
3.4.1 Reducing substance 
The volume of potassium permanganate solution consumed by 20ml of testing 
solution should not be more than 1.5mL differe nt from that consumed by the blank testing 
solution, which is [c(KM nO4)=0.002mol/L].  
3.4.2 Heavy metal 
The total amount of heavy me tal in the testing solution should not exceed 1.0µg/mL 
and no trace of cadmium and stannum should be found.  
3.4.3 Acidity and alkalinity 
The difference in ph values of the testing so lution and blank solution should not exceed 
1.0. 
3.4.4 Evaporation residue 
The total amount of evaporation residue of 50 mL of testing solution should not exceed 
2.0mg. 
3.4.5 Vinyl chloride monomer 
The amount of vinyl chloride monomer should not exceed 1.0µg/g. 
3.5 Biological properties 
The biological properties of the tubes must  meet the national assessment requirement 
for relevant biology.     GB xxxx__xxxx 
 
 34 Inspection Method 
 
4.1 Tube size and deviation limit 
 The outside diameter, inside diameter a nd wall thickness should be measured with 
projectors or implements with a precision of not less than 0.01mm. The length should be 
measured using implements with 1mm scale . 
4.2 Visual inspection  
 The visual inspection is to be conducted in natura l daylight indoors .  
4.3 Inspection of physical and mechanical properties  
4.3.1 Change of conditions and testing environment 
Samples should be placed in an environment of 23±2 oC in temperature, and a relative 
humidity of 45%-55% for 4 hours. Testi ng should be conducted in these conditions . 
4.3.2 Tensile strength and rupture tensile strain 
 
Tubes with inside diameter equal to or less than 8mm should be measured directly. 
Total sampling length should be 120mm with an e ffective length of 50mm; tubes with inside 
diameter larger than 8mm should be sample d according to Model 5A in Graph A. 2 as 
specified in GB/T 1040.2-2006 a nd the testing speed should be 100mm/min. The rest should 
be conducted according to requiremen ts as listed in GB/T 1040.2-2006.   
4.3.3 Compression set 
4.3.3.1  Equipment 
Splints, cushion blocks and vemier calliper with a precision of no less than 0.02mm are 
to be used. 
4.3.3.2  Sampling 
3 sections are to be sampled in every group; each section is to be 50mm.  
4.3.3.3  Testing procedure 
To test the outside diameter, samples are to be placed between splints cushioned by 
blocks measuring half of the outside diameter in thickness  and be placed in temperature of 
23±2 oC for 24 hours. Then samples are to be rem oved for 1 hour before measurements are to 
be taken on the side that has taken the comp ression. Compression set is  to be calculated 
according to Formula 1. The largest value of the 3 samples is to be taken with precision of 
0.1%. GB/T xxxx__xxxx 
 4  
       D
0-D 1 
         q = -------------- X 100 ………………………………(1)      D
o 
 
In the formula:  q --- compression set, expressed in %;    D
0--- outside diameter prior to compression, unit: mm 
   D 1 ---outside diameter at the comp ression side after compression, unit: 
mm 
4.3.4 Shore hardness 
4.3.4.1  Testing equipment 
Mix crushed tubes or raw materials, place in  a plastic melting machine at a temperature 
of 165±5 oC and melt for 5-10 minutes. Remove and place in a hydraulic press at a 
temperature of 165±5 oC for 15-20 minutes and melt sheets in  the following order: pre-heat 
with no compression, heated with compre ssion and cooled down after compression .  
The test sheets should be smooth with thickness no less than 5mm.  
4.3.4.2  Testing procedure 
To be tested according to requirements specified in GB/T 2411-1988.  
4.4 Inspection of chemical properties  
4.4.1 Preparation of testing solution 
 Sample tubes are to be cut to 1cm in lengt h and placed in a glass container. Water is 
to be added in the ratio of 2:1 for the total su rface of both the inside and outside of the tube 
samples (cm2) and water (ml). Put on the lid on the glass container and keep for 24 hours at a 
temperature of 37±1oC. Separate the sample and the liquid, and cool down to room 
temperature. The liquid is to be used as a solution .  
Fill another glass container with the same amount of water. Make another solution in 
the same condition to be used as a blank solution. 
4.4.2 Reducing substance 
The test is to be conducted according to requirement 5.2.2 as listed in GB/T 14233.1-
1998. 
4.4.3 Heavy metal 
 
The total amount of heavy meta l is to be tested accordi ng to requirement 5.6.1 as listed 
in GB/T 14233.1-1998. 
The total amount of cadmium and stannum is to be tested according to requirement 
5.9.1 as listed in GB/T 14233.1-1998. 
4.4.4 Acidity and alkalinity 
 The test is to be conducted according to requirement 5.4.1 as listed in GB/T 14233.1-
1998.   GB xxxx__xxxx 
 
 54.4.5 Evaporation residue 
  The test is to be conducted according to requirement 5.5 as listed in GB/T 14233.1-
1998. 
4.4.6 Vinyl chloride monomer 
The test is to be conducted according to requirement as listed in GB/T 4615-1984. 
4.5 Inspection of biological properties 
 The biological properties are to be tested according to the requirement as listed in 
GB/T 16886.1.   
5 Inspection Rules 
 
5.1 Inspection Categories 
5.1.1 Factory Inspection 
Factory inspection includes the following: visual inspection, size, tensile strength, 
rupture tensile strai n, Shore (a) hardness , reducing substance in chem ical properties, total 
amount of heavy metal, acidity and alkalinity. 
5.1.2 Type Inspection  
Type inspection should usually be conducted on ce a year as listed in Clauses 3.1 to 3.4. 
Type inspection should also be carried out  if any one of the following applies: 
a) When new products are being made or old products are being made in a new factory; 
b) After official production has been co mmissioned, and whenever major changes 
happen to raw materials or ma nufacturing, which might affect  the property of the products; 
c) When production is resumed afte r it has stopped for over six months; 
d) When the result of a factory inspecti on varies significantly from the result of a 
previous type inspection;  
e) When the National Quality Inspec tion Body requests a type inspection. 
5.1.3 Biological Property Inspection is usually  conducted once every four years. 
Biological property inspection s hould be conducted if any one of the following applies: 
a) When new products are being made or old products are being made in a new factory; 
b) After official production has been co mmissioned, and whenever major changes 
happen to raw materials or production processe s, which might affect the property of the 
products; 
5.2 Group Batching and Sampling  
5.2.1 Group Batching 
Tubes made with the same raw materials, with the same formula and in the same 
production process and of the same specifi cation and same batch number should be 
considered as one group, but the total numb er must not exceed 20,000m per group. When the 
total is less than 20,000m , all the tubes produced in 7 consec utive days can be grouped as one 
batch.  GB/T xxxx__xxxx 
 6 5.2.2 Sampling 
Visual inspection, specification and size insp ections should be conducted as specified 
in GB/T 2828.1-2—3. Normal inspection one-off sa mpling plan will be adopted with an 
average inspection standard, accep table quality limit AQL4.0 a nd a sampling plan as Table 3. 
The inspection of the physical and mechanical properties, chemical properties and biological 
properties of the tubes should be based on suffici ent numbers of samples from those that have 
passed the visual, specifica tion and size inspections.  
Table 3 Sampling Plan 
 Unit: meter 
Batch size 
N Sample size 
n Acceptance number
Ac Rejection number 
Re 
3-15 3 0 1 
16-25 5 0 1 
26-50 8 1 2 
51-90 13 1 2 
91-150 20 2 3 
151-280 32 3 4 
281-500 50 5 6 
501-1200 80 7 8 
1201-3200 125 10 11 
3201-10000 200 14 15 
10001-35000 315 21 22 
5.3 Determination Rules 
Visual inspection, specification and size inspect ion are to be determined as shown in 
Table 3. If any sample fails the inspections of the physical and mechanic al properties, or the 
chemical properties, double th e amount should be randomly sampled from the same batch for 
re-inspection purpose. If the resu lt of the re-inspection is satis factory, the batch of tubes can 
be declared as having met the quality standar d. If any sample fails th e biological properties 
inspection, the whole batch should be  declared as sub-standard.  
 
6 Packaging, Symbols, Transportation and Storage 
 
6.1 Packaging 
6.1.1 Internal Packaging 
The products must be wrapped and sealed in two layers. 
6.1.2 External Packaging 
Paper boxes are suitable for external p ackaging, with each box not exceeding 16kg in 
weight.  
6.2 Symbols 
Each package should contain a Certificat e of Inspection, specifying the date of 
inspection and the code of an inspector .    GB xxxx__xxxx 
 
 7Printed on the internal p ackage should be the following information: product 
specification, quantity, nominal hardness, fact ory lot number, name of manufacturer, trade 
mark and so on.   
The external packaging should bear the following symbols: 
a. Product name, model number, quantity; b. Product factory lot number; c. Name of manufacturer and address; d. Gross weight; e. Size; f. Symbols signifying “handle with care", “keep dry” and “keep away from heat", 
which must be in line with requirements set in GB 191.  
6.3 Transportation 
During transit, the produ cts should be handled with care, kept away from the sun, kept 
dry and kept away from heavy load. Packaging must be kept intact.  
6.4 Storage 
The products should be kept in a cool, dry and well ventilated storeroom with no 
erosive gas, and kept at a mi nimum of 200mm off the floor and away from the walls. The 
products can be stored for up to one year .  
 
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