上海翻譯公司完成醫(yī)療器械-醫(yī)用注射器具檢驗(yàn)英文翻譯

State Standard of the People’s Republic of China
GB/T 14233. 1—2008
In stead of GB/T 14233.1—1998
Test methods for infusion, transfusion, injection equipment for medical use-
Part 1: Chemical analysis methods
Published in Nov. 3, 2008     Implemented in Oct. 1, 2009
Published by
State Administration of Quality Supervision, Inspection and Quarantine, the People’s Republic of China and China National Standardization Management Committee

 
1.Scope
2. Normative cited files
3. General rules
4. Inspection solution preparation
5. Dissolved matter analysis method of inspection solution
6. Total content analysis method of heavy metal in materials
7. Content analysis method of part of heavy metal in the materials
8. Residue on ignition
9. Determination method of ethylene oxide residue---gas chromatography
10. Analysis on ethylene oxide residue----colorimetric method
Reference literature

                                Preface
GB/T 14233 “medical infusion, transfusion, injection equipment test method” is divided into 2 parts:
The first part: method of chemical analysis;
The second part: biological experimental method.
This part is the first part of GB/T 14233
This part replaces GB/T 1233. 1-1998 “medical infusion, transfusion, injection equipment test methods first part: chemical analysis method”. Considering that GB/T 1233.1-1998 has been widely cited by many products and standards and in order to avoid the confusions caused by the changes of standard terms numbers, the best is tried to keep the term numbers to be corresponding with that of original standard in this revision. For the contents that need to be revised, the amendment is made on the original position of terms. For the increased contents, the new serial number and methods are added on the basis of original serial number.
Comparing with GB/T 14233.1-1998, the main changes of this part are as following:
----To modify the solution preparation and express method
----To increase the inspection solution preparation method of the irregular shape products that have shorter use time (not exceeding 24h) and larger volume, the irregular shape products that have longer use time (exceeding 24h) and the absorbent materials.
----To increase the experimental method of turbidity and luster;
----To modify the test method of oxide, pH, heavy metal, ammonium, zinc, burning residue and ethylene oxide residue.
----To increase the test method of fluorescence spectrum of atom;
----To cancel the test method of sulfate.
This part is put forward by the State Food and Drug Administration.
This part is under the management of the National Medical Infusion Appliances Standardization Technical Committee.
The draft of this part is issued by the unit: Jinan Quality Supervision and Inspection Center for Medical Devices, the State Food and Drug Administration.
This part is mainly drafted by: Luo Hong Yu, Pan Hua Xian, Shi Yan Ping, Sun Guang Yu, Li Ke Fang, Qin Dong Li, Liu Bin, Liu Li Li, Guo Lun.
The previous versions publication of replaced standard includes:
---GB/T 14233.1-1993;
___GB/T 14233.1-1998.
 
  

 
   Medical infusion, transfusion, injection equipment test method
 
The first part: method of chemical analysis
 
1. Scope
This part of GB/T 14233 specifies the chemical analysis method of medical infusion, transfusion and injection equipment.
 
This part is applicable to the chemical analysis of medical infusion, transfusion, injection and assorted apparatus made from medical polymer materials. The chemical analysis of other medical polymer products can also refer to it.
 
2. Normative cited files.
The terms of following documents become the terms of this part through the citing of this part of GB/T 14233. For all the cited documents marked with date, all the subsequent amendments (excluding the corrigendum contents) or revisions are all not applicable to this part. However, the parties who have followed this part to come to agreement are encouraged to research if the latest version of these documents can be used. For all the cited documents that do not marked with date, the latest version is not applicable to this part.
GB/T 601 the preparation of chemical reagents standard titration solution
GB/T 6682 the analysis on water specification and test method of laboratory (GB/T 6682-2008, ISO 3696;1987, MOD)
The People’s Republic of China Pharmacopoeia (2005 edition) 2^nd part
 
3. General rules
3.1 All the analysis of this part is carried out on the basis of two parallel test groups. The result should be within the allowable relative deviation limit and the arithmetic average value will be regarded as the determination result. For example, if one is qualified and another is unqualified, it cannot be calculated averagely. It should be re-determined again.
 
3.2. If there is no special provision, all the reagents of this part are analytical reagents.
 
3.3 If there is no special provision, the test water of this part should meet the 2^nd grade water requirement of GB/T 6682.
 
3.4  All the terms “indoor temperature” of this part refer to 10℃~ 30 ℃.
 
3.5. All the terms “accurate weight” of this part mean the accuracy of weight reaches 0.1㎎.
 
3.6 All the terms “accurately measure” of this part mean that the pipettes that can meet the accuracy requirement of relevant national standard provision are used to measure.
 
3.7  The constant weight of weight method means that the weight differences should not exceed 0.3㎎ after the samples are consistently burned or dried 2 times.
 
3.8 If there is no special provision, all the glass containers used in this part are the borosilicate glass containers.
 
4. Preparation of test solution
4.1 The preparation of test solution should imitate, to the best, the condition experienced by the products in the process of application (for example, the production application are, time, temperature etc.) The imitation of extraction time should not be less than the normal use time of products. When the products are used for very long time (exceeding 24h), the accelerated test conditions should be considered to prepare the inspection solution. But the feasibility and rationality should be verified.
 
4.2 The method of inspection solution preparation should enable, to the best, all the tested surfaces of sample to be extracted.
 
4.3  It recommended that the preparation method of inspection solution should be selected in table1.
 
 
Table 1. Preparation method of inspection solution.

S/No.	Preparation method of inspection solution	Applicable product description
1	3 sets of samples and glass flasks are connected into a circulatory system. And 250mL water is added. The temperature keeps in 37+/-1 degree. Through a peristaltic pump, a medical silicone rubber tube as short as possible is imposed on so as to make the water circulate with the speed of 1L/h for 2h.All the liquids are collected and cooled to the indoor temperature as inspection solution. The same volume water is taken and put into a glass flask. And the blank contrast solution is prepared in the same way.	The vitro infusion pipe products that use time is short (not more than 24h).
2	The sample is taken out and cut into 1cm long piece, put into the glass containers. According to the proportion of 2:1 between the total area (m2) of sample inside and outside surface and the water (mL), the water is added. After the cover is put on, it is put under 37+/-1 degree for 24h. The sample is separated from the liquid and cooled to the room temperature as inspection solution. The same volume water is taken and put into the glass container. The blank contrast solution is prepared in the same way.	The vivo catheter that uses time is very short (not more than 24h).
3	The part with even thickness is taken from the sample and cut into 1cm2 piece. After they are washed and dried, they are put into the glass containers. According to the proportion of 5:1(or 6:1) between the total area (cm2) of sample inside and outside and the water (mL), the water is added. After the cover is put on, they are put into the pressure steam sterilizer. They are heated under 121+/-1 degree for 30 minutes. After the heating is ended, the samples are separated from the liquid and cooled to the indoor temperatures as inspection solution. The same volume water is taken and put into the glass containers. The blank contrast solution is prepared in the same way.	The products that use time are longer (more than 24h).
4	The water is added into the sample to the nominal capacity. After it is put under the temperature of 37+/-1degree for 8h (or 1h), the sample is separated from the liquid and cooled to the indoor temperature as inspection solution. The same volume water is taken and put into the glass containers. The blank contrast solution is prepared in the same way.	The container products whose use time is very short (less than 1h).
5	The water is added into the sample to the nominal capacity. After it is put under the temperature of 37+/-1 degree for 24h, the sample is separated from the liquid and cooled to the indoor temperature as inspection solution. The same volume water is taken out and put into the glass containers. The blank contrast solution is prepared in the same way.	The container products whose use time is very short (less than 24h).
6	The sample is taken out. 10mL water is added into each sample ( or the appropriate weight of sample can be followed, such as 0.1g-0.2g, to add 1mL water. After it is put under the temperature of 37+/-1 degree for 24h(or 8h or 1h), the samples are separated from the liquid and cooled to the indoor temperature as inspection solution. The same volume water is taken out and put into the glass containers. The blank contrast solution is prepared in the same way.	The small irregular products whose use time is very short (less than 24h).
7	The sample is taken out. The appropriate weight, such as 0.1g-0.2g, can be followed to add 1mL water. After it is put under the temperature of 37+/-1 degree for 24h(or 8h or 1h), the sample is separated fro the liquid and cooled to the indoor temperature as inspection solution. The same volume water is taken out and put into the glass containers. The blank contrast solution is prepared in the same way.	The irregular products with short use time (less than 24h) and larger volume.
8	The sample is taken out. The proportion that 0.1g-0.2g sample is added by 1mL water can be followed to add the waters. After it is extracted under 37+/-1 degrees for 72h (or 72h under the temperature of 50+/-1 degree, or 24h under 70+/-1 degree), the sample is separated with the liquid and cooled into the indoor temperature as inspection liquid. The same volume water is put into the glass containers. The blank contrast solution is prepared in the same way.	The irregular products with longer use time (more than 24h).
9	The sample is taken out. The sample weight (g) or the surface area (cm2) can be followed to add the appropriate proportion waters from which the water absorption is removed. Under the temperature of 37+/-1 degree, it is extracted for 24h(or 72h or 8h or 1h). And then, the sample is separated from the liquid and cooled to the room temperature as inspection solution. The same volume water is taken out and put into the glass containers. The blank contrast solution is prepared in the same way.	The products of absorbent materials.
Note 1: If the preparation condition of sample is used in the parentheses, it should be marked in the product standard. Note 2: The selection of temperature should consider the highest temperature bore possibly in the clinical application. If it is the polymer, the temperature should be selected under the glass transition temperature.
0.1g/mL proportion is suitable. to the irregular shape and low density porous solid product；0.2g/mLproportion is suitable to the irregular shape solid products.

 
5. Dissolved matter analysis method of inspection solution
5.1 turbidity and luster
5.1.1 turbidity
5.1.2 solution preparation
Hydrazine sulfate solution: 1.00g of hydrazine sulfate is weighted and dried under 105 degree. After it is put into 100mL volumetric flask, the water is added to dissolve and dilute to the degree scale. It is shook even and put for 4h to 6h.
Hexamethylenetetramine solution: In the 100ml glass bottle with stopper, 25mL water is used to dissolve 2.5g of hexamethylenetetramine solution.
 
Primary opalescent suspensions: 25mL hydrazine sulfate solution is added into the hexamethylenetetramine solution. After mixture, it is put for 24h. If these suspensions are stored in the glass containers without surface defects, they can keep stable for 2 months. The suspensions should not adhere to the glass containers. Before use, it should be fully mixed.
 
Standard color solution: Table 2 is followed to prepare the contrast suspensions. Before use, it should be oscillated.
 
Table 2 contrast suspension  Unit: mL

Contrast suspension	0.5	1	2	3	4
Milk color standard	2..5	5.0	10.0	30.0	50.0
Water	97.50	95.0	90.0	70.0	50.0

 
5.1.1.2 experiment procedure
5.1.1.2.1 method one
The neutral glass flat tubes that are colorless, transparent and have the inner diameter of 15mm-25mm are used. The inspection solution is compared with the contrast suspensions newly prepared according to the above. The vitro liquid layer depth is 40mm. The prepared contrast suspensions is put for 5 min. Under the diffuse daylight of sun, the solution is observed perpendicular to the black background.
 
5.1.1.2.2 method two
Under the condition of indoor temperature, the inspection solution and the equivalent contrast suspensions are separately put in the colorless transparent neutral glass flat tube with inner diameter of 15mm-16mm. After the prepared contrast suspensions are put for 5 minutes, they should be put under the umbrella shed light with the illumination of 1000LX in the darkroom. They can be observed and compared in the horizontal direction.
 
5.1.2 lustre
In accordance with the inspection method of solution color in Appendix IX A of “the People’s Republic of China (2005 edition) 2^nd part”, it is carried out.
 
5.2 reduction materials (easily oxide)
5.2.1 method one: direct titration
5.2.1.1 principle
The potassium permanganate is a strong oxidant. In the acid medium, the potassium permanganate can have reaction with the reducing substances and is reduced to 
 

5.2.1.2 preparation of solution
Sulfuric acid solution: 128mL sulfate acid is measured and slowly injected into 500mL waters. After cooled, it should be diluted to 1000mL.

Sodium oxalate solution : 6.70g of sodium oxalate is weighted and dried under 105℃-110℃. The water is added to dissolve and dilute it to 1000mL.
 
Sodium oxalate solution : Before use, the sodium oxalate solution  is taken out. The water is added to dilute them to 10 times.
 
The standard titration solution of potassium permanganate: Before use, the standard titration solution of potassium permanganate  is taken out. The water is added to dilute it for 10 times. If necessary, it can be boiled, cooled, filtered and then its concentration can be calibrated.
 
1.3 experiment procedure
20mL inspection solution is accurately measured and put into the Erlenmeyer flasks. And 3ml standard titration solution of potassium permanganate, which has the regulated concentration in the product standard and 5mL sulfuric acid solution are accurately added. After they are heated to boil and maintain the boiling for 10 min. After slightly cold, 5mL sodium oxalate solution of relevant concentration is accurately added. They are put on the water bath and heated to 75-80 degree. When the standard titration solution of potassium permanganate with the regulated concentration is used to titrate it till it turns red. And it keeps unfaded for 30s, which will be the end. At the same time, it can be compared with the blank contrast solution with the same lot.
 
Note:  potassium permanganate standard titration solution is corresponding to  sodium oxalate solution;  potassium permanganate standard titration solution is corresponding tosodium oxalate solution.
 
 
5.2.1.4 result of calculation
The content of reducing substances( easily oxidized substances) is showed by the consumption of potassium permanganate solution. It is calculated in the formula (1):
 
 
In the formula:
V----consumption volume of potassium permanganate standard titration solution, unit is mL.
Vs----volume of potassium permanganate standard titration solution consumed by inspection solution, unit is mL
Vo----volume of potassium permanganate standard titration solution consumed by blank solution, unit is mL.
Cs----real concentration of potassium permanganate standard titration solution, unit is mol/L.
Co----regulated concentration of potassium permanganate standard titration solution in the standard, unit is mol/L.
 
5.2.2 method two: indirect titration method
5.2.2.1 principle
When the reduction materials contained in the infusion is heated in the acid condition, it will be oxidized by potassium permanganate. The excessive potassium permanganate may oxidize potassium iodide into iodine, while iodine is reduced by sodium thiosulfate.
5.2.2.2 preparation of solution
Sulfuric acid solution: 128mL sulfate acid is measured and injected into 500mL water. After cooled, it is diluted to 1000mL.
Potassium permanganate solution: same as 5.2.1.2
Potassium permanganate solution: same as 5.2.1.2
 
Starch indicator solution: 0.5g starches are weighted to dissolve in 100mL water. After it is heated to boil, it is cooled for backup.
 
Sodium thiosulfate standard titration solution: It can be prepared and calibrated in accordance with the method in GB/T 601.
 
Sodium thiosulfate standard titration solution : Before use, sodium thiosulfate standard titration solutionis taken out to be diluted 10 times by the water that is newly boiled and cooled.
 
5.2.2.3 test procedure
10mL inspection solution is accurately measured and put into 250mL iodine bottle. 1mL sulfuric acid solution, 10ml regulated concentration potassium permanganate solution in the product standard are precisely added. After it is boiled for 3 min, it is cooled rapidly. And 0.1g potassium iodide is added. After the plug is sealed, shake it. Sodium thiosulfate standard solution of same concentration is immediately used to titrate the solution to be colorless.
 
The same method is used to titrate the blank contrast solution.
 
5.2.2.4 calculation results
The content of reducing substances (easily oxidized substances) is showed by the consumption quantity of potassium hyperrmanganate solution. The formula (2) is followed to calculate it:

In the formula
V------Consumption volume of potassium permanganate solution, unit is mL;
Vs----volume that inspection solution consumes sodium thiosulfate standard titration solution, unit is mL.
Vo-----volume that blank solution consumes sodium thiosulfate standard titration solution, unit is mL.
Cs----actual concentration of sodium thiosulfate standard titration solution, unit is mol/L.
Co----Regulated concentration of potassium permanganate standard titration solution, unit is mol/L
 
5.3 chlorides
5.3.1 principle
Under the acidic condition, the chloride ion will react with silver nitrate and generate the precipitation of silver chloride.
 
5.3.2 preparation of solution
Chloride standard stock solution (0.1mg/mL): 0.165g gasification sodium is weighted under 500 degree—600degree, burned to the constant weight, dissoluted into water, moved to the containing flask of1000mL and diluted into the marked level.
Chloride standard solution:  Before uses, chloride standard stock solution is accurately measured and diluted into the required concentration.
Silver nitrate solution(17.5g/L): 1.75g silver nitrate is weighted, dissolved into water, diluted to 100mL and stored in the brown bottle.
Nitric acid solution: 1.5mL nitric acid is taken and diluted with water to 1000mL.
 
5.3.3 test procedure
10mL inspection solution is accurately measured and added into 50mL Nessler tube. 10mL dilute nitric acid solution is added.( if the solution is not clarified, it should be filtered. The filtrate is put in 50mL Nessler tube). The water is added to about 40mL. And then the test solution is obtained.
 
10mL chloride standard solution is accurately measured to another 50mL Nessler tube. 10mL dilute nitric acid is added. The water is added to about 40mL. And then the standard contrast solution is obtained.
 
1.0mL silver nitrate solution is respectively added into the above 2 tubes, diluted with water to 50mL. It is placed in the dark for 5min, put on the black background and then observed from the top of colorimetric tube. The turbidity is compared between test solution and standard contrast solution.
 
If the test solution has the colors, except as otherwise regulated, 2 section of test solution can be taken and placed respectively in 50mL Nessler tube. In one of them, 1mL silver nitrate solution is added, shook till it becomes even, and placed for 10 min. If it becomes turbidity, it can be filtered repeatedly till the filtrate solution becomes completely clarified. And then the regulated quantity of chloride standard solution and water are added appropriately till it becomes 50mL. Shake it and place it in the dark for 5 min as contrast solution. In another of them, 1.0mL silver nitrate solution is added appropriately till it becomes 50mL. Shake it and place it in the dark place for 5 min. It can be compared with the contrast solution according to the above method. And then the result will be obtained.
 
5.4 pH
5.4.1 method one
Inspection solution and blank contrast solution are taken. The pH meter is used to measure respectively the pH value. The differences between the 2 will be the result of test.
 ____________________________________________________________________
1). 20mL inspection solution can also be taken;
2). When 20mL inspection solution is taken, 20mL potassium permanganate solution, 2mL sulfuric acid solution and 1.0g potassium iodide are also added.
 
5.4.2 method two
5.1.2.1 preparation of solution
Sodium hydroxide standard titration solution : preparation and calibration in accordance with the provision of GB/T 601.
 
Sodium hydroxide standard titration solution: Before use, sodium hydroxide standard titration solutionis taken, diluted with water 10times.
 
Hydrochloric acid standard solution: preparation and calibration in accordance with GB/T 601.
 
Hydrochloric acid standard solution: Before use, hydrochloric acid standard solutionis taken and diluted with water 10 times.
 
Tashiro indicator: 0.2g methyl red and 0.1gof methylene blue are dissolved into 100mL ethanol (Volume fraction is 95%).
 
5.4.2.2 test procedure
20mL inspection solution is accurately measured and put in 100mL grinding-mouth bottle. 0.1mL Tashiro indicator is added. If the solution color turns purple, sodium hydroxide standard titration solution is used to titrate; if it turns green, hydrochloric acid standard titration solutionis used to titrate till it becomes grey. The consumption volume of sodium hydroxide standard titration solutionor hydrochloric acid standard titration solutionwill be as the test result.
 
5.4.3 method three
5.4.3.1 solution preparation
Sodium hydroxide standard titration solution: Same as 5.4.2.1
Sodium hydroxide standard titration solution: Same as 5.4.2.1
Hydrochloric acid standard titration solution: Same as 5.4.2.1
Hydrochloric acid standard titration solution: Same as 5.4.2.1
Phenolphthalein indicator solution(10g/L): 1g phenolphthalein is taken, dissolved into ethanol (volume fraction is 95%) and diluted to 100mL.
Methyl red indicator solution （1g/L）: 0.1 methyl red is weighted, dissolved into ethanol (volume fraction is 95%) and diluted into 100mL.
 
5.4.3.2 test procedure
2 drops of phenolphthalein indicator solution is added into 10mL inspection solution. The solution should not turn red. When 0.4mL sodium hydroxide standard titration solutionis added, it should turn red. 0.8mL hydrochloric acid standard titration solution is added, the red should disappear. When 5drops of methyl red indicator solution are added, the solution should turn red.
 
5.5 evaporation residue
5.5.1 test procedure
Evaporating dish is dried to constant weight in advance under 105 degree. 50mL inspection solution is measured and added into evaporating dish. It is steamed dry on the water bath and dried to constant weight in the constant temperature oven of 105 degree. The blank contrast solution is determined with the same method.
 
5.5.2 calculation result
According to formula (3), evaporation residue is calculated:

In this formula:
m----quality of evaporation residue, unit is mg;
m11---evaporating dish quality without inspection solution, unit is g
m12---evaporating dish quality with inspection solution, unit is g
m01----evaporating dish quality without blank solution, unit is g
m02----evaporating dish quality with blank solution, unit is g.
 
5.6 total content of heavy metal
5.6.1 method one
5.6.1.1 principle
In slight acid solution, the heavy metal, such as lead, chromium, copper, zinc etc, can react with thioacetamide and generate the insoluble nonferrous sulphide. Taking lead as representative, the standard solution is prepared and compared so as to measure the total content of heavy metals.
 
5.6.1.2 preparation of reagent and solution
Acetate buffer (pH3.5): 25g ammonium acetate is taken. After 25mL water is added and dissolved, 38mL hydrochloric acid (7mol/L) is added. Hydrochloric acid (2mol/L) or ammonia solution (5mol/L) are used to adjust pH value to 3.5 (potentiometric method indicating). The water is used to dilute it to 100mL. So the required solution is obtained.
 
Thioacetamide reagent: 4g thioacetamide is taken. The water is added to dissolve to 100mL, preserved in the refrigerators. Before use, 5.0mL mixed liquid ( formed by 15mL sodium hydroxide (1mol/L), 5.0mL water and 20mL glycerin) is taken. 1.0mL above thioacetamide solution is added. The solution is heated on water bath for 20s, cooled and used immediately.
 
Lead standard stock solution (0.1mg/mL): 0.16g lead nitrate is weighted, dissolved with 10mL nitric acid solution (1+9), moved to 1000mL volumetric flask and diluted with water to the marked level.
 
5.6.1.3 test procedure
25mL inspection solution is precisely measured in 25mL Nessler tube. Another 25mL Nessler tube is taken out. And 25mL lead standard solution is added. And 2mL acetate buffer solution (pH3.5) is respectively added into the above 2 colorimetric tube. And then 2mL thioacetamide reagent solution is respectively added, shook evenly and placed for 2 minutes. It can be observed from the topside under the white background. The color depth can be compared.
 
If the inspection solution has colors, a small quantity of diluted caramel solutions or other colored solutions without any interference can be added into the standard contrast solutions so as to keep the color of inspection solution consistent. And then 2mL thioacetamide reagent can be respectively added into the inspection solution and the standard contrast solutions shook evenly, placed for 2 min. Under the white background, it can be observed from the topside. And the color depth can be compared.
 
5.6.2 method two
5.6.2.1 principle
In alkaline solution, the heavy metal, such as lead, chromium, copper, zinc etc can react with sodium sulfide and generate the insoluble ferrous sulfide. Taking lead as representative, the standard solution is prepared so as to compare the colors and determine the total content of heavy metal.
5.6.2.2 preparation of solution
Sodium hydroxide solution (43g/L): 4.3g sodium hydroxide is taken. And the water is added so as to dissolve into 100mL. The required solution is obtained.
 
Sodium sulfide solution (100g/L): Before use, 1g sodium sulfide is weighted. The water is added so as to dissolve into 100mL. So the required sodium sulfide solution is obtained.
 
Lead standard stock solution (0.1mg/mL): Same as 5.6.1.2
 
Lead standard solution: Same as 5.6.1.2
 
5.6.2.3 test procedure
In 25mL Nessler tube, 25mL inspection solution is accurately measured. Another 25mL Nessler tube is taken out. 25mL lead standard solution is added. And then 5mL sodium hydroxide solution is respectively added into the above 2 Nessler tubes. And then 5 drops of sodium sulfide solution are respectively added and shook evenly. It can be observed from the topside under the white background. The color depth can be compared.
 
5.7 UV absorbance
The inspection solution is taken. If necessary, 0.45μm milipore filtration can be used. Within 5h, 1cm cuvettes can be used to measure the absorbance within a specified wavelength range, comparing with the blank contrast solution.
 
5.8 ammonium
5.8.1 principle
In the alkaline solution, ammonium ion can react with Nessler’s reagent and generate the yellow substance. Through the comparison with standard contrast solution, the content of ammonium can be determined.
 
5.8.2 preparation of solution
Sodium hydroxide solution (40g/L): 4.0g sodium hydroxide is taken out. Water is used to dissolve and dilute to 100mL.
 
Nessler’s reagent (alkaline potassium mercuric iodide solution): 10g potassium iodide is taken. 10mL water is added and dissolved. And then two mercuric oxide saturated solution is slowly added. When the solution is added, it should be stirred at the same time so as to generate the red precipitate, which will not dissolve. 30g potassium hydroxide is added. After dissolution, 1mL or more than 1mL two mercuric oxide saturated solution is added. And the appropriate quantity of water is used to dissolve into 200mL. The solution is statically placed and precipitated. And then the required solution is obtained. At the time of use, the above clear solution is inclined and took. Examination: 2mL solution is taken and added into 50mL water containing 0.05mg ammonia. It should turn yellow brown immediately.
 
Ammonium standard stock solution (0.1mg/mL): 0.297g ammonia chloride is weighted and dried to constant weight under 105 degree-110degree. The water is used to dissolve and dilute into 1000mL.
 
Ammonium standard solution: Before use,  ammonium standard stock solution is accurately measured and diluted to the required concentration.
____________________________________________________________________________
3). 10mL inspection solution can also be taken, so the amount of lead standard solution will be 10mL.
 
 

5.8.3 test procedure
10mL inspection solution is accurately measured in 25mL Nessler tube. Another 25mL Nessler tube is taken. 10mL ammonium standard solution is added. 2mL sodium hydroxide solution (40g/L) is respectively added into the above 2 Nessler tube so as to make the solution turn alkaline. And then the distilled water is used to dilute to 15mL. 0.3mL Nessler’s reagent is added. After 30s, it can be examined. The color depth can be compared between inspection solution and contrast solution.
 
5.9 part of heavy metal element
5.9.1 atomic absorption spectrophotometer
5.9.1.1 instrument
Atomic absorption spectrophotometer should be operated in accordance with the instructions at the time of use.
Analysis method (standard curve line method)
In the recommended concentration range of instrument, at least 5 standard solutions containing the elements to be tested and with sequentially increased concentration are prepared. The solvent for the preparation of standard solution is used to adjust the absorbance to zero. And then the absorbance of each standard solution is sequentially determined. The standard curve line is made on the basis of concentration.
 
The inspection solution and the blank contrast solution are determined. According to the absorbance, the relevant concentration is found out in the standard curve line. And the element content is calculated.
 
Note: When atomic absorption spectrometry method is used to determine the content of heavy metal, the range can be determined through the evaporation of inspection solution so as to make the concentration enhanced. For the determination of each metal, 2.5mL nitric acid solution (10g/L) is added into 250mL inspection solutions.
 
5.9.2. colorimetric analysis method
5.9.2.1zinc
5.9.2.1.1 principle
For Zinc and Zinc reagent colorimetric, the absorbance is determined at 620nm.
5.9.2.1.2 preparation of solution
Potassium chloride solution (7.455g/L): 7.455g potassium chloride is weighted and diluted with water to 1000mL.
 
Sodium hydroxide solution(4g/L): 4.0g sodium hydroxide is weighted and diluted with water to 1000mL.
 
Potassium chloride and boric acid buffer solution (pH0=9.0): 3.090g boric acid is weighted and added into 500mL potassium chloride solution (7.455g/L) and dissolved. And then 210mL sodium hydroxide solution (4g/L) is added. So the required solution is obtained.
 
Sodium hydroxide solution (40g/L): 4.0g sodium hydroxide is weighted, dissolved with water and diluted to 100mL.
 
Zinc reagent solution: 0.130g Zinc reagent is taken. 2mL sodium hydroxide solution is added and diluted with water to 100mL.
 
Zinc standard stock solution(0.1mg/mL): 0.440g zinc sulfate (ZnSo4.7H2O) is weighted, dissolved into water, moved into 1000mL volumetric flask and diluted to the marked level.
 
Zinc standard solution: Before use,  Zinc standard stock solution is accurately weighted, diluted to the required concentration.
 
5.9.2.1.3 test procedure
5mL inspection solution is accurately measured and placed into 10mL volumetric flask. 2mL boric acid potassium chloride buffer solution and 0.6mL Zinc reagent solution are added. It is diluted with water to the marked level and placed for 1h.
 
5mL blank solution is accurately measured in 10mL volumetric flask. 2mL boric acid potassium chloride buffer solution and 0.6mL zinc reagent solution are added, diluted with water to the marked level and placed for 1h. This is the reference solution for determination of absorbance.
 
5mL Zinc standard solution is accurately measured. The standard contrast solution is made with the same method, shook, placed for 1h and then put in 1cm cuvette. The absorbance is determined at 620nm wavelength. The zero point is adjusted with the reference solution.
 
5.9.2.1.4 calculation result
According to the measured absorbance value, formula (4) is followed to calculate the relevant content of heavy metal in the inspection solution:
 
In the formula:
Cs--- relevant heavy mental concentration of inspection solution, unit is nanogram per milliliter(μm/mL)
Cr--- relevant heavy metal concentration of standard contrast solution, unit is nanogram per milliliter(μg/mL)
As---absorbance of inspection solution
Ar---absorbance of standard contrast solution
 
5.9.2.2 lead
5.9.2.2.1 principle
Under the weak alkaline (pH8.6-11) condition, lead ions will react with dithizone chloroform solution and generate the red complex.
 
5.9.2.2.2 preparation of reagent and solution
Dithizone chloroform stock solution(1.0g/L): 0.10g dithizone is weighted, dissolved into chloroform, diluted into 100mL, stored in a brown bottle and preserved in the refrigerator. If the dithione is impure, it can be purified in the following way: 0.20g dithizone is weighted, dissolved in 100mL chloroform and filtered into 250mL funnel through degreasing cotton. Every time, 20mL ammonia water with 3% volume fraction is extracted repeatedly several times till the chloroform phase almost have no green colors. The aqueous phases are merged in another separatory funnel. Every time, 10mL chloroform is used to wash the aqueous phase 2 times. The chloroform phase is discarded. The aqueous phase is acidized with sulphuric acid of 10% volume fraction till dithizone is precipitated. And then every time 100mL chloroform  is used to extract it for 2 times. After chloroform phases are merged, it is poured into the brown bottle.
 
Dithizone chloroform of 0.15 absorbance: Before use, a suitable amount of dithizone chloroform stock solution is taken out and diluted with chloroform till the absorbance becomes 0.15 (wavelength is 510nm, cuvette is 1cm).
 
Phenol red indicator solution (1g/L): 0.1g phenol is weighted, dissolved into 100mL ethanol. And then the required solution is obtained.
 
Acid ammonium citrate solution （500g/L）： 50g ammonium citrate solution is taken out and dissolved into 100mL water. The phenol red is used as indicator. And ammonia is used to alkalize (pH8.5-9). Dithizone chloroform stock solution is used to extract. The consumption of every time is 20mL till the green color of dithizone remains unchanged. And the chloroform layer is discarded and the water layer is taken.
 
Potassium cyanide solution (100g/L): 10g potassium cyanide solution is weighted, dissolved in water and diluted to 100mL. If the reagents are impure, 10g potassium cyanide should be first dissolved into 20mL water. According to the purification method of acid ammonium lemon solution (500g/L), the solution is purified and diluted into 100mL.
 
Hydroxylamine hydrochloride solution (100g/L): 10g hydroxylamine hydrochloride is weighted, dissolved into water and diluted into 100mL. If the reagent is impure, the solution can be purified with the purification method of acid ammonium lemon solutions.
 
Lead standard stock solution (0.1mg/mL): 0.160g lead nitrate is weighted, dissolved with 10mL nitric acid solution (1+9), moved into 1000mL volumetric flask and diluted with water to the marked level as standard stock solution.
 
Lead standard solution: Before use, lead standard solution is accurately measured and diluted to the required concentration.
 
5.9.2.2.3 test procedure
50mL inspection solution is accurately measured and placed into 250mL separatory funnel. Another 1mL lead standard solution is taken and added into another 250mL separtory funnel. The blank contrast solution is added to dilute it to 50mL. 0.2mL hydrochloric acid, 3 drops phenol red indicator, 2 drops hydroxylamine hydrochloride solution and 2mL ammonium citrate solution are respectively added into the 2 separatory funnels and mixed evenly. Ammonia is used to adjust pH value to 8.5-9(the solution will change red from yellow). 1mL potassium cyanide solution and 10mL dithizone chloroform solution are added, shook for 2 min and placed quietly for stratification.Dithizone chloroform solution is placed into colorimetric tube. Within 20min-60min, spectrophotometer is used to determine the absorbance at 510nm wavelength. The zero point is adjusted with the blank solution.
 
5.9.2.2.4 calculation result
According to the measured absorbance value, the formula (4) is followed to calculate the relevant heavy mental content of inspection solution.
 
5.9.3 atomic fluorescence spectrometry
5.9.3.1 instrument
At the time of use, atomic fluorescence photometer should be operated in accordance with instrument instruction.
 
5.9.3.2 analysis method (standard curve line method)
In the recommended concentration range of atomic fluorescence photometer, at least 5 standard solutions containing the elements to be tested and with the sequentially increased concentration should be prepared. And the reagent used to prepare the standard solution will be used as the blank solution. And the fluorescence intensity of each standard  solution will be sequentially determined. And the standard curve lines will be made on the basis of concentration.
 
The inspection solution and the blank contrast solution will be determined. According to the absorbance, the relevant concentration can be traced on the standard curve lines so as to calculate the content of elements.
 
6 total content analysis method of heavy metal in material
6.1 principal
In acid solution, the heavy metal, such as lead, cadmium, copper, zinc etc, can react with thioacetamide and generate insoluble nonferrous sulphide. Lead standard solution is used as standard for the comparison of color. Their total content can be determined.
 
6.2 preparations of reagents and solution
They can be carried out in accordance with 5.6.1.2.
 
6.3 preparation of inspection solution
1g-2g sample is taken, cut into 5mmX5mm piece, put into porcelain crucible, slowly burned to full carbonization and cooled. And then 0.5mL-1mL sulfate acid is added for wetness. It will be heated with low temperature till the sulfuric acid vapor disappears. 0.5mL nitric acid is added and steamed dry. After the steam of nitric oxide is released completely, it will be cooled. And then it is burned under the temperature of 500 degree—600 degree till it becomes ash. After cooled, 2mL hydrochloric acid is added and steamed dry on water bath. And then 15mL water is added. One drop of phenol phthalein test solution is added. And then ammonia solution is added till the above solution becomes slight red. 2mL acetate buffer solution (pH3.5) is added, slightly heated and dissolved. And then the solution is moved to 25mL Nessler tube. The water is added so as to make it become 25mL inspection solution. Another porcelain crucible with 0.5mL-1mL sulfuric acid, 0.5mL nitric acid and 2mL hydrochloric acid is placed on water bath and steamed dry. 2mL acetate buffer(pH3.5) solution and 15mL water are added, slightly heated and dissolved. And then the solution is moved to 25mL Nessler tube. A certain amount of lead standard solution is added and diluted with water into 25mL as standard contrast solution.
 
6.4 test procedure
2mL thioacetamide reagent is respectively added in inspection solution and standard contrast solution, shook evenly and placed for 2 min. It can be observed from the topside under the white background so that the color depth can be compared.
 
Note. If the inspection solution has color, a small amount of caramel solution or other interference-free colored solution can be added into standard contrast solution so as to make it consistent with the color of sample solution.
7.content analysis method of partial heavy metal in materials
7.1 atomic absorption spectrophotometer
7.1.1 instrument
At the time of use, atomic absorption spectrophotometer should be operated in accordance with the  instructions.
7.1.2 analysis method (standard curve line method)
In the recommended concentration range of instrument, at least 5 standard solutions containing the contents to be tested and with the sequentially increased concentration should be prepared. The solvent for the preparation of standard solution is used to adjust absorbance to be zero. And then the absorbance of each standard solution is sequentially determined. The standard curve line will be made according to concentration.
 
The inspection solution and the blank contrast solution prepared according to 6.3 are determined. According to absorbance, the relevant concentration can be found out in the standard curve line so as to calculate the content of elements.
 
7.2 colorimetric analysis method
7.2.1 preparation of inspection solution
1g-2g of sample is taken, cut into 5mmX5mm pieces, put into porcelain crucible, slowly burned till it is fully carbonized. And then, it is cooled. 0.5mL-1mL sulfuric acid is added for wetness. After it is heated with low temperature till sulfuric acid vapor disappears, 0.5mL nitric acid is added and steamed dry. After the steam of nitric oxide is removed, it will be cooled. Under 500 degree-600 degree, it will be burned so as to make it become ash. After cooled, 2mL hydrochloric acid is added and steamed dry on water bath. After that, 15mL water is added. One drop of phenol phthalein inspection solution is added. And then ammonia inspection solution is added till the above solutions become slight red. And then water is added so as to produce 25mL inspection solution.
 
The blank contrast solution is made in the same way.
 
7.2.2 Zinc
The inspection solution and the blank contrast solution are taken in accordance with the regulated method of 5.9.2.1.
 
7.2.3 lead
The inspection solution and the blank contrast solution are taken in accordance with the regulated method of 5.9.2.2
 
7.3 atomic fluorescence spectrometry
7.3.1 sample digestion
7.3.1.1 wet digestion: 2g sample is taken, accurately weighted and cut into 5mmX5mm pieces. 30mL nitric acid and 1.25mL sulfuric acid are added into 100mL conical flask, shook and placed overnight. It is put on electric heating plate, heated and digested. When the digestion solution is treated to about 10mL, there are still unresolved matters or the color becomes deeper. It should be taken out and cooled. And 5mL-10mL nitric acid is added. When it is digested to about 10mL, it should be observed again. So it can be repeated two or three times. Attention should be paid to avoid carbonization. After it is cooled, 25mL water is added, and then evaporated till white smoke of sulfate acid appears. After cooled, the water is used to move the content to 50mL volumetric flask. The water is added so as to produce 50mL inspection solution. The same method is used to prepare the blank contrast solution.
 
7.3.1.2 dry ashing: 1g-2g sample is taken and accurately weighted in crucible. 10mL magnesium nitrate solution with 150g/L concentration is added, shook evenly and evaporated with low temperature. 1g magnesium oxide is carefully covered in the dry slag. It will be carbonized till there is no black smoke. Again, it will be dry-ashing for 4h under the temperature of 550 degree. And then it can be taken out and cooled. 10mL hydrochloric acid (1+1) is carefully added so as to neutralize the magnesium oxide and dissolve the ash. And it is moved to 50mL volumetric flask. The water is added so as to produce 50mL inspection solution. The same method is used to prepare the blank contrast solution.
 
7.3.1.3 other method: It will be reasonably made in accordance with sample content and craftsmanship.
 
7.3.2 instruments
At the time of use, atomic fluorescence photometer should be operated in accordance with instrument instruction.
 
7.3.3 analysis method
In the recommended concentration range of instruments, at least 5 standard solution containing the elements to be tested and with sequentially increased concentration should be prepared so as to produce the solvent that the standard solution uses and adjust absorbance to zero. And then, the absorbance of each standard solution will be sequentially determined. The standard curve lines will be made according to concentration.
 
The inspection solution and the blank contrast solution are determined. According to the absorbance, the relevant concentration can be found out in the standard curve line so as to calculate the content of element.
 
8. Burning residue
2g-5g samples is taken, cut into 5mmX5mm and placed in the crucible that has been burnt to constant weight. It will be weighted accurately. In fuming cupboard, it will be slowly burnt till it is completely carbonized. It should be cooled. 0.5mL-1mL sulfuric acid is added so as to make it wet. It will be heated with low temperature till sulfuric acid vapor is removed completely. And it will be burnt under 700 degree-800 degrees till it is completely ashing. It will be put in the dryer, placed till the temperature is same as room temperature and weighted. And then, it will be burnt to constant weight under 700degree-800degree.
 
If the residue is needed to check heavy metal, the burning temperature should be controlled at 500degree-600degree.
 
8.2 calculation result

In formula:
A----residue on ignition, %
Mo---crucible quality before sample is added, unit is g.
M1---crucible quality after sample is added, unit is g.
M2---crucible quality after sample is burnt, unit is g.
 
9. residue determination of ethylene oxide---gas phase chromatography method
9.1 instruments
At the time of use, gas phase chromatograph instrument should be operated in accordance with instrument instruction.
 
9.2 analysis method
Any gas phase chromatograph analysis method can be used if it is proved that the analysis is reliable. “Reliable analysis” means, when the instrument that regulates the residue of a specified epoxy ethane (EO), the selected analysis method has sufficient accuracy, precision, selectivity, linearity and sensitivity and is suitable to the equipment that needs analysis.
 
For different products, the evaluation of necessary method should be carried out so as to determine the selected method reliability.
 
9.3 sample extraction method
9.3.1 general rules
There are 2 basic extraction methods of sample used to determine the EO residue of medical devices that use EO sterilization: stimulation using extraction method and limit extraction methods.
 
Simulation using extraction method refers to the method to make the extraction try its best to stimulate the use of product. This stimulation process enables the measured EO residue equivalent to the real EO intake that the patients use this instrument. Limit extraction method means that the determined EO amount of once-again extraction is less than 10% of measured value of initial extraction, or the measured cumulative residue of extraction has no evident increase. It is suitable to prepare the extraction solution after the sample is taken, otherwise, the test samples should be sealed and preserved in the metal containers sealed by polytetrafluorethylene.
 
When the method of this part is cited and if there is no nominated extraction method, limit extraction method is followed to carry out.
 
9.3.2 stimulation using extraction method
When stimulation using extraction method is used, the extraction method and the collection method under the strictest predicted using condition should be regulated in the product standard according to the product specified using condition.  And the following conditions should be taken:
a).extraction medium: water will be regarded as extraction medium.
b). extraction temperature: the whole or part of equipments in contact with human body should be extracted under 37 degree (the temperature of human body) and the equipment that will not contact directly with human body should be extracted under 25 degree( room temperature).
c) extraction time: When the extraction time is determined, it should be considered to be carried out under the time condition of the recommended or predicted strictest use. But it should not be less than 1h.
d) extraction surface: the surface that the equipment contact with medical liquid or blood.
 
9.3.3 limit extraction method
Limit extraction method includes thermal limit extraction method and solvent extraction limit.
This part recommends limit extraction method that the water is taken as solvent.
Note: GB/T 16886.7 provides the relevant information measured by the residue of epoxy ethane.
9.4 text procedure of limit extraction method
9.4.1 preparation of test solution
The part where the EO relative residue that contact with human body is the highest in the products is taken out for experiment. It can be cut into small pieces with 5mm length (or 10mm2 platelet). 1.0g is taken out to place into 20mL extraction containers. And 5mL is accurately added, sealed and balanced for 40 min under the temperature of 60+/-1 degree.
 
9.4.2 preparation of epoxy ethane standard stock solution
50mL volumetric flask with dry outside is taken. About 30mL water is added. The cork is added. It will be accurately weighted. Injectors are used to inject about 0.6mL epoxy ethane. The cork will not be covered. The bottle will be gently shaken evenly. And then the cork is covered and the bottle is weighted. The weight differences before and after weighting will be the weight of epoxy ethane contained in the solution. The water is added to the marked level so as to produce the solution that contains about 10mg/mL of epoxy ethane as standard stock solutions.
 
9.4.3 to draw standard curve line
The stock solution is used to prepare 6 series concentration of standard solution from 1μg/mL to 10μg/mL. 5mL is accurately measured, placed in 20mL extraction containers, sealed and balanced for 40min in the constant temperature (60+/-1 degree).
 
The injectors are used to rapidly take the upper gas sequentially from the standard sample after balance, inject the sample room and record the peak (or area) of epoxy ethane so as to draw the standard curve lines. (X; EO concentration, μg/mL; Y; peak height or area)
 
9.4.4 measurement of test samples
The sample injectors are used to rapidly obtain the top gas from sample extraction container, inject into the sample room and record the peak height(or area) of epoxy ethane.
 
According to the standard curve lines, the relevant concentration of samples will be calculated.
 
If the results of tested samples are not within the range of standard curve lines, the concentration of standard solution should be changed so as to re-draw the standard curve lines.
 
If the results of tested sample are not within the range of standard curve line. And the concentration of standard solution should be changed so as to re-draw the standard curve line.
 
9.5 result of calculation
The residue charges of ethylene oxide solution are showed by the absolute content and the relative content.
 
9.5.1 Formula (6) is followed to calculate the absolute content of ethylene oxide in the unit product.
 

In formula:
Weo----the absolute content of ethylene oxide per product, unit is mg;
5------the volume of measured extraction solution, unit is mg.
c------the corresponding concentration of test solution found in the standard curve line, unit is nanograms per milliliter(μg/mL)
m1-----the quality per product, unit is g.
m2----the sample weight, unit is gram (g)
 
9.5.2 formula (7) is followed to calculate the relative content of ethylene oxide in the samples.

 
In formula:
Ceo---the relative content of epoxy ethane in the products, unit is mirograms per gram (μg/g)
5----the measured volume of extraction solution, unit is mL.
c----the relevant concentration of test solution found in the standard curve line, unit is nanograms per milliliter (μg/mL).
m---sample weight, unit is g.
 
10. Residue analysis of ethylene oxide---colorimetric method
10.1 principal
Under acidic condition, ethylene oxide is hydrolyzed to ethylene glycol. Ethylene glycol is oxidized  by permanganic acid and generate formaldehyde. And formaldehyde react with fuchsin-sulfurous acid solution and generate the purple red compound. Through colorimetric analysis, the content of ethylene oxide can be obtained.
 
10.2 preparation of solution
0.1mol/L hydrochloric acid: 9mL hydrochloric acid is taken and diluted to 1000mL.
 
Periodate solution (5g/L): 0.5g periodate is weighted, dissolved into water and diluted to 100mL.
 
Sodium thiosulfate solution (10g/L): 1.0g sodium thiosulfate is weighted, dissolved into water and diluted to 100mL.
 
Sodium sulfite solution (100g/L): 10.0g anhydrous sodium sulfite is weighted, dissolved into water and diluted to 100mL.
 
Fuchsin-sulfurous acid solution: 0.1g alkalinous fuchsin is weighted. 120mL hot water is added and dissolved. After cooled, 20mL 10% sodium sulfite solution and 2mL hydrochloric acid are added and placed in the dark place. The test solution should have no color. If it is found to be light red, it should be re-prepared.
 
Ethylene glycol standard stock solution: A clean 50mL volumetric flask with dry outside is taken. And about 30mL water is added. It will be accurately weighted. 0.5mL ethylene glycol is accurately measured, rapidly added into the bottle and shaken evenly. The solution is accurately weighted. The weight difference of two times is the weight of ethylene glycol contained in the solution. The water is added to the marked level and mixed evenly. Formula (8) is followed to calculate the concentration:

In formula:
 
c----standard stock solution concentration of ethylene glycol, unit is g/L
m----quality of ethylene glycol in solution, unit is g.
 
Ethylene glycol standard solution (concentration ): 1.0mL standard stock solution is accurately measured and diluted with water to 1000mL.
 
10.3. sample extraction method
 
10.3.1 general rules
Same as 9.3.1
 
10.3.2 stimulation using extraction method
Same as 9.3.2, but 0.1mol/L hydrochloric acid is used as extraction medium.
 
10.3.3 limit extraction method
 
10.3.3.1. The representative part of sample is taken and cut into 5mm-length piece. 2.0g is weighted and placed in the container. 10mL 0.1mol/L hydrochloric acid is added and placed for 1h under the room temperatures as test solution.
 
10.3.32  For the container type of sample, 0.1mol/L hydrochloric acid can be added to nominal capacity. Under the temperature of 37+/-1 degree, the constant temperature is kept for 1h as test solution.
 
10.4 test procedure
10.4.1 5 Nessler tubes are taken. And 2mL of 0.1 mol/L hydrochloric acid is respectively and accurately added. And then 0.5mL, 1.0mL, 1.5mL , 2mL, 2.5mL glycol standard solution are accurately added. Another Nessler tube is taken. And 2mL of 0.1mol/L hydrochloric acid is accurately added as blank contrast solution.
 
10.4.2  0.4mL of periodate solution (5g/L) is respectively added into the above tubes, shaken evenly, placed for 1h and then sodium thiosulfate solution (10g/L) is respectively dropped till the appearing yellow color just disappears. And then 0.2mL fuchsin-sulfurous acid is respectively added, diluted with distilled water to 10mL and shaken evenly. Under the condition of 35 degree-37degree,  it is compared with the blank solution at the wavelength of 560nm so as to measure the absorbance and draw the standard curve line of absorbance-volume.
 
10.4.3   2.0mL test solution is accurately measured in Nessler tube. And the procedure of 10..2 is followed to operate so that the measured absorbance can be used to check the relevant volume of test solution from the standard curve line.
 
10.5 result of calculation
Ethylene oxide residue should be showed by the absolute content or the relative content.
 
10.5.1  Formula (9) should be followed to calculate the absolute content of epoxy ethane in the samples:

In the formula:
Weo---absolute content of epoxy ethane per product, unit is mg;
V-------relevant volume of test solution found in the standard curve line, unit is mL;
C1---standard solution concentration of ethylene glycol, unit is g/L;
m---quality per product, unit is g.
 
10.5.2. Formula (10) should be followed to calculate the relative content of ethylene oxide:

In formula:
Ceo---relative content of epoxy ethane per product, unit is μg/g;
V-----relevant volume of test solution found in the standard curve line, unit is mL;
C1---standard solution concentration of ethylene glycol, unit is grams per liter (g/L);
 
10.5.3.  For the container type of sample, the formula (11) should be followed to calculate the absolute content of ethylene oxide in the containers:

In formula:
Weo---absolute content of epoxy ethane per product, unit is mg;
V----relevant volume of test solution found in the standard curve line, unit is mL;
C1---standard solution concentration of ethylene glycol, unit is grams per liter (g/L);
V1---nominal capacity per sample, unit is mL.

[1] GB/T 602-2002 chemical reagent   preparation of standard solution for impurities determination;
[2] GB/T 603-2002 chemical reagent   preparation of reagent and product used in test method;
[3] GB/T 16886.7-2001 biological evaluation of medical devices- part seven: sterilization residuals of ethylene oxide