GB/T 14233.2-2005 PDF English
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| GB/T 14233.2-2005 | English | 155 |
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Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods
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| GB/T 14233.2-1993 | English | 265 |
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Test methods for infusion, transfusion, injection equipment for medical use. Part 2: Biological test methods
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GB/T 14233.2-2005: Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods
---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/GBT14233.2-2005
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing GB/T 14233.2-1993
Test Methods for Infusion, Transfusion, Injection
Equipment for Medical Use –
Part 2.Biological Test Methods
Issued on. NOVEMBER 17, 2005
Implemented on. MAY 1, 2006
Jointly Issued by. General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ);
Standardization Administration (SAC) of the People's
Republic of China.
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative References... 5
3 Sterility Test... 6
4 Bacterial Endotoxin Test... 8
5 Pyrogen Test... 11
6 Acute Systemic Toxicity Test... 13
7 Hemolytic Test... 15
8 Cytotoxicity Test... 17
9 Sensitization Test (Maximum Dose Method)... 21
10 Intradermal Reaction Test... 23
11 Implantation Test... 24
Appendix A (Informative) Sub-acute (Sub-chronic) Systemic Toxicity Test
... 29
Appendix B (Informative) Interaction Test With Blood (Devices)... 35
Appendix C (Informative) Preparation of Common Cell Culturing
Solution and Culture Solution... 48
1 Scope
This Part of GB/T 14233 specifies the biological test methods of medical infusion,
transfusion and injection equipment.
This Part is applicable to medical infusion, transfusion and injection equipment.
2 Normative References
The following normative documents contain provisions which, through reference of this
Part of GB/T 14233, constitute provisions of this standard. For dated references,
subsequent amendments (excluding corrigendum) or revisions of these publications
do not apply. However, all parties who enter into an agreement according to this
standard are encouraged to study whether the latest editions of these documents are
applicable. For undated references, the latest edition of the normative documents
referred to applies.
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and
Testing (GB/T 16886.1-2001, IDT ISO 10993-1.1997)
GB/T 16886.4 Biological Evaluation Of Medical Devices - Part 4.Selection of
Tests for Interactions with Blood (GB/T 16886.4-2003, ISO 10993-4.2000, IDT)
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5.Test for in Vitro
Cytotoxicity (GB/T 16886.5-2003, ISO10993-5.1999, IDT)
GB/T 16886.6 Biological Evaluation of Medical Devices - Part 6.Tests for Local
Effects after Implantation (GB/T 16886.6-1997, IDT ISO 10993-6.1996)
3 Sterility Test
3.1 Purpose
This test inoculates the medical equipment or its vat liquor into culture medium, so as
to test if the test substance is subject to bacteria and fungus contamination.
3.2 Reagent
Sodium chloride solution of which the mass concentration is 9 g/L, and other diluent
and flushing fluid that meet the requirements of Chinese Pharmacopoeia.
3.3 Main Equipment
Super-clean bench, optical microscope, constant temperature incubator, thermostatic
water bath, pressure steam sterilizer, and electric drying oven
3.4 Preparation Before the Test
3.5 Culture Medium
It is used to cultivate aerobic (anaerobic) bacteria and fungus, the sensitivity inspection
of culture medium. Other requirements shall comply with the provisions of "Sterility
Test Method" in Appendix of "Chinese Pharmacopoeia (Part II)".
4 Bacterial Endotoxin Test
4.1 Purpose
This test is the "Gel Method" as specified in "Bacterial endotoxin test method" of
Appendix in "Chinese Pharmacopoeia (Part II)". It utilizes the mechanism of
agglutination produced by TAL (Tachypleus Amebocyte Lysate) and bacterial
endotoxin, so as to judge if the maximum level of bacterial endotoxin in test substance
meets the requirements.
4.2 Reagent
National standard product of bacterial endotoxin, working standard product of bacterial
endotoxin, TAL(Tachypleus Amebocyte Lysate), and examination water for bacterial endotoxin.
4.3 Main Equipment
Super-clean bench, constant temperature incubator, thermostatic water bath, electric
drying oven, and vortex mixers.
4.4 Preparation Before Test
4.4.1 Instrument Treatment
The vessel for the test needs to be treated to remove the possibly existing exogenous
endotoxin. Put the glass dish in electric drying oven at 180°C to dry-roast for at least
2h, or at 250°C to dry-roast for at least 30min.
4.4.2 TAL (Tachypleus Amebocyte Lysate) sensitivity verification test
4.4.3 Test substance interference test
4.5 Test Methods
4.5.1 Test substance quantity
For the same batch, at least 3 units of test substance are required.
4.5.2 Leaching medium
Examination water for bacterial endotoxin.
4.5.3 Test solution preparation
According to the bacterial endotoxin limits specified by product standard to determine
the leaching medium volume, it shall select the following suitable methods to prepare
test solution.
4.5.4 Test procedure and result judgment
They shall be conducted according to the requirements of "Gel Method" in "Inspection
method of bacterial endotoxin" of Appendix of "Chinese Pharmacopoeia (Part II)".
4.5.5 Test Report
The following information should be provided in the test report.
5 Pyrogen Test
5.1 Purpose
In this test, inject the leach liquor of medical equipment into rabbit vein; observe the
rise of body temperature of rabbit, so as to judge if the test substance has potential
material thermogenic action.
5.2 Reagent
It is the aseptic pyrogen-free sodium chloride injection with mass concentration of 9g/L.
5.3 Main Equipment
Super-clean bench, electric drying oven, electric heating thermostatic water bath,
pressure steam sterilizer, and pyrogen tester.
5.4 Preparation Before Test
5.4.1 Pyrogen removal from instrument
All the glass dishes in contact with test solution are dry-roasted at 180°C in electric
drying oven for at least 2h, or at 250°C for at least 30 min. Other appropriate methods
may also be adopted to remove pyrogen.
5.4.2 Temperature measurement instrument
Pyrogen thermodetector or clinical thermometer for rectal use with the precision of
±0.1°C shall be adopted to determine the body temperature of rabbit.
5.5 Test Method
5.5.1 Test solution preparation
Appropriate leaching condition shall be selected according to the requirements of GB/T 16886.12.
5.5.2 Test procedure
It shall be conducted according to the requirements of "pyrogen test" of Appendix in
"Chinese Pharmacopoeia (Part II)" with the injection amount of rabbit as 10mL/kg.
5.5.3 Result judgment
If the test substance meets the requirements of "pyrogen test" in Appendix of "Chinese
Pharmacopoeia (Part II)" after preliminary examination or re-examination, they are
judged as free from material thermogenic action.
5.6 Test Report
Test report should provide the following information.
6 Acute Systemic Toxicity Test
6.1 Purpose
In this test, inject the leach liquor of medical equipment into the vein and inner cavity
of mice; observe whether the mice have toxic reaction and death within specified time,
so as to judge whether the test substance has potential acute systemic toxicity action.
6.2 Reagent
The sodium chloride injection with mass concentration of 9 g/L, and fresh refined
vegetable oil.
6.3 Main Equipment and Tool
Pressure steam sterilizer, animal balance, and hypodermic needle.
6.4 Preparation before test
6.4.1 Instrument sterilization
All the equipment which are to contact with the test solution shall be placed in the
pressure steam sterilizer at the temperature of 121°C for 30 min.
6,4.2 Preparation for the test animal
6.5 Test Method
6.5.1 Preparation of test solution
Appropriate leaching conditions are selected according to the requirements of GB/T
16886.12; sodium chloride injection with the mass concentration 9 g/L and two types
of leach liquor of vegetable oil are prepared for each test substance. Control solution
of leaching medium is prepared under the same conditions.
6.5.2 Test solution injection
6.5.3 Observation of animal reaction after injection
After completion of injection, observe the immediate reaction of mice; observe and
record the general state, toxic performance and dead animal number of the treatment
group and control group animals at 4h, 24h, 48h and 72h; weigh the animal body mass
at 72h. Animal reaction observation judgment is specified according to Table 1.
6.5.4 Result judgment
6.5.4.1 Within observation period of 72h, if the reaction of animals in test team is not
greater than the animals in control group, the test substance is judged as free from
acute systemic toxic reaction.
6.5.4.2 If two or more animals in test group have medium toxic symptom or die, the
test substance is judged as with acute systematic toxic reaction.
6.5.4.3 If the animals in test group have slight toxic symptom, or not more than one
animal has medium toxic symptom, or die, or that although the animal is free from toxic
symptom, but the mass of animal body in the group drops generally, then take another
10 mice as a group for retest. If the retest results meet the requirements of 6.5.4.1, the
test substance is judged as free from acute systematic toxic reaction.
6.6 Test Report
The following information should be provided in the test report.
7 Hemolytic Test
7.1 Purpose
In this test, the medical equipment is directly in contact with blood. External hemolysis
degree of test substance is judged through determination of hemoglobin amount
released by red blood cell. This test is not applicable to evaluate the equipment-with- drug.
7.2 Reagent
Potassium oxalate, sodium chloride injection with the mass concentration of 9 g/L, and
fresh anticoagulant rabbit blood.
7.3 Main equipment
Electric heating constant temperature water bath, spectrophotometer and centrifuger.
7.4 Preparation of Test Solution
7.5 Fresh Diluted Anticoagulant Rabbit Blood Preparation
Blood is taken from the hearts of healthy rabbits according to the blood volume for test.
If 10mL of blood is taken, add 0.5 ml of potassium oxalate solution with the mass
concentration of 20 g/L; prepare it into fresh anticoagulant rabbit blood. Take 8 mL of
fresh anticoagulant rabbit blood; add 10mL of sodium chloride injection with the mass
concentration of 9 g/L for dilution.
7.6 Test Method
For test substance group, each tube is added with 5g of test substance; or in the case
of 7.4.2, add test substance with the leaching proportion specified in GB/T 16886.12;
add 10mL of sodium chloride injection then.
7.7 Result Calculation
Mean of three tubes is taken for absorbance of test substance group and control group.
The absorbance of negative control tube shall not be greater than 0.3; and that of
positive control tubes shall be 0.8± 0.3; otherwise retest shall be conducted.
7.8 Result Judgment
Appropriate acceptance judgment index is determined according to the expected
clinical usage and equipment material characteristics of medical equipment.
7.9 Test Report
The following information should be provided in the test report.
8 Cytotoxicity Test
8.1 Purpose
In this test, medical equipment leach liquor is in contact with cultured cell; the test
substance's toxic effect on external cells is evaluated according to the observation of
cellular morphology, proliferation and inhibition influence.
8.2 Reagent
Sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, disodium
hydrogen phosphate, monopotassium phosphate, sodium hydroxide, glucose, phenol
red, trypan blue, disodium EDTA (EDTA), trypsin, Eagle culture medium, RPMI 1640
culture medium, (fetal) calf serum, Penicillin G (sodium benzoate), streptomycin
sulphate, ethanol, phenol, and dimethyl sulfoxide (DMSO).
8.3 Main Equipment and Instrument
Super-clean bench, carbon dioxide (CO2) incubator, constant temperature water bath,
refrigerator, inverted microscope, optical microscope, pressure steam sterilizer, suction
flask, magnetic stirrer, and culture plate (ware).
8.5 Test Methods
8.5.1 Cell strain
For cell strain in test, ATCC CCLI [NCTC clone 929 (L cell) or other suitable cells may
be adopted. Vigorous cells with passage of 48 h~ 72 h shall be adopted for test.
8.5.2 Leaching medium
The cell culture liquid with or without serum, the sodium chloride injection with the mass
concentration of 9 g/L.
8.5.3 Control sample
8.6 Result Judgment
Test substance cytotoxicity reaction degree is analyzed and judged under the condition
that negative control and positive control produce the expected reaction.
Notes 1.The test solution inspection concentration recommended in this test is 100 %,; it is applicable to
medical infusion, transfusion and injection equipment. Other types of medical equipment may adjust test
solution inspection concentration according to clinical application condition, e.g. 100%, 75%, 50% and 25% etc.
8.7 Test Report
The following information should be provided in the test report.
9 Sensitization Test (Maximum Dose Method)
9.1 Purpose
In this test, medical equipment leaching liquor is adopted to contact the cavy skin to
evaluate the potentiality of delayed type hypersensitivity of test substance initiated
under test conditions.
9.2 Reagent
Sodium chloride injection, fresh refined vegetable oil, rochlorobenzene
(dinitrochlorobenzene, DNCB), sodium lauryl sulfate, and Freund complete adjuvant
with mass concentration of 9 g/L.
9.3 Main Equipment and Instrument
Pressure steam sterilizer, electric razor, hypodermic syringe, and glass mortar.
9.4 Preparation Before Test
9.5 Test Methods
9.5.3 Preparation of test solution
According to the requirements of GB/T 16886.10, select appropriate leaching
conditions, sodium chloride injection with the mass concentration 9 g/L, and/or
vegetable oil leaching liquor.
9.5.4 Test procedure and result judgment
They shall be operated according to "Maximum Dose Sensitization Test" specified in GB/T 16886.10.
9.6 Test Report
The following information should be provided in the test report.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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