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YY/T 1690-2020: Determination of residual of ethylene chlorohydrin(ECH) from plasticized polyvinyl chloride infusion equipment for single use
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| YY/T 1690-2020 | English | 119 |
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Determination of residual of ethylene chlorohydrin(ECH) from plasticized polyvinyl chloride infusion equipment for single use
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YY/T 1690-2020
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Basic data | Standard ID | YY/T 1690-2020 (YY/T1690-2020) | | Description (Translated English) | Determination of residual of ethylene chlorohydrin(ECH) from plasticized polyvinyl chloride infusion equipment for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 6,616 | | Date of Issue | 2020 | | Date of Implementation | 2021-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the method for the determination of 2-chloroethanol (ECH) residues in single-use polyvinyl chloride infusion sets. This standard applies to single-use polyvinyl chloride infusion sets sterilized with ethylene oxide. | YY/T 1690-2020: Determination of residual of ethylene chlorohydrin(ECH) from plasticized polyvinyl chloride infusion equipment for single use
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Determination of residual of ethylene chlorohydrin(ECH) from plasticized polyvinyl chloride infusion equipments for single use
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Disposable PVC infusion equipment
Determination method of 2-chloroethanol residue
2020-02-21 released
2021-01-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
Drafting organizations of this standard. Shandong Medical Device Product Quality Inspection Center, Shandong Zhongbaokang Medical Device Co., Ltd.
The main drafters of this standard. Shen Yong, Xu Zhizhou, Meng Kai, Gong Jiafu, Bo Xiaowen, Liu Aijuan, Zhao Changshuai.
Introduction
Ethylene oxide (EO) has a broad-spectrum and high-efficiency sterilization effect. It is one of the high-efficiency chemical low-temperature sterilants and is widely used in the sterilization of medical devices.
Pan application. However, ethylene oxide is a toxic substance, and many articles are adsorbent. The residual ethylene oxide is hydrolyzed and then interacts with the product.
Chlorine reacts to produce 2-chloroethanol (ECH).
Data shows that ECH is a flammable liquid that irritates the body surface, has acute toxicity, and is quickly absorbed through the skin at a toxic dose.
body. ECH is slightly mutagenic, has the potential to produce fetal toxicity and teratogenic changes, and can cause damage to several organ systems in the body.
Injuries include lungs, kidneys, central nervous system and cardiovascular system. At present, GB/T 16886 specifies when using EO sterilized medical devices
When ECH exists in the machine, the maximum allowable residual amount of ECH should also be specified.
A variety of analytical methods can be used to determine the residual amount of ECH, typical methods include gas chromatography (GC), gas chromatography/mass spectrometer combined
Usage (GC/MS) etc. This standard uses headspace gas chromatography as the basic method and gives test procedures.
Due to the large differences in the clinical application of such devices, in some cases, the published literature methods include those given in this standard.
The method presented may not be applicable to all devices. Therefore, any method that shows that its analysis is reliable can be used. "Analytical reliability" means
When the extraction liquid obtained under specific extraction medium and conditions is analyzed for ECH residual content, the selected method has sufficient precision,
Accuracy, linearity, sensitivity and selectivity.
Disposable PVC infusion equipment
Determination method of 2-chloroethanol residue
1 Scope
This standard specifies the method for the determination of 2-chloroethanol (ECH) residues in disposable polyvinyl chloride infusion devices.
This standard applies to disposable polyvinyl chloride infusion devices sterilized with ethylene oxide.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 12808 Single-marked pipette for laboratory glassware
3 General
3.1 The room temperature in this standard, unless otherwise specified, should be 10℃~30℃.
3.2 The test water in this standard should meet the requirements of GB/T 6682.
3.3 The containers used in this standard shall be borosilicate glass containers if there are no special regulations.
3.4 The precision measurement involved in this standard should be measured with a pipette that meets the accuracy requirements in GB/T 12808.
4 Preparation of extract
4.1 General
There are two basic extraction methods used to determine the ECH residues of medical devices. The simulated use of extraction is the standard method, and the limit extraction
Law is an acceptable alternative in certain situations. The selected extraction method should be able to represent the greatest risk to patients in the expected use of the product
It is not only the pursuit of analysis efficiency or minimizing the apparent concentration of residues.
Small instruments should be placed in a suitable container for extraction. When the device is too large for complete extraction, it may be necessary to select several representative
The device components are extracted to ensure the credibility of the data.
To select a representative part of the device, either of the following two methods can be used. If it contains several different materials, each group
The proportion of the total mass of the sample should be consistent with the proportion of the total mass of the component in the total mass of the device under test. Another alternative is to choose
The evaluation certificate is to test the component with the highest residual content on the device, and the selected method should be confirmed.
4.2 Simulated extraction (standard method)
Use the discussed liquid that represents the most unfavorable actual clinical contact and the extraction method and conditions for extraction, and then take part of the extraction
The extract is tested. In the simulated use extraction method, water is usually used as the extraction liquid.
Due to the large differences in the clinical use of the equipment, especially the actual contact of the infusion equipment with a wide variety of media, the simulated immersion
When mentioning, if the test medium produces interference under the test conditions specified in Chapter 5, other conditions demonstrated by methodology should be used.
4.3 Ultimate extraction (acceptable alternative method)
The limit extraction method is used to determine the total amount of residue on the device. The limit extraction method is an acceptable alternative and can provide useful information.
Information, the measured results indicate greater than or equal to the patient's acceptable dose. Because this extraction method eliminates the influence of time on dosimetry
There is no guarantee that most of the residual amount measured will be released to the patient on the first day of contact with the device or at the end of the first month.
Note. If the limit extraction test results exceed the maximum allowable human dose, consider using simulated extraction (4.2) to prepare extracts for further testing.
5 Recommended determination method---limit extraction headspace gas chromatography
5.1 Reagents
ECH reference substance. purity not less than 95.0%, CAS number. 107-07-3.
5.2 Apparatus and equipment
Headspace-gas chromatograph (FID detector).
5.3 Working standard solution
Take a dry and clean 100mL volumetric flask, add about 40mL water, add a stopper, and accurately weigh. Take a certain amount of ECH and add capacity
In the bottle, do not add the stopper, shake it gently, cover the stopper, and weigh it accurately. The difference between the two weighings is the weight of ECH contained in the solution. add water
To the mark, prepare a standard stock solution with a concentration of about.2000mg/L.
Prepare ECH series standard solutions with a concentration range of 4mg/L~100mg/L with standard stock solution, and prepare at least 5 concentrations.
5.4 Gas chromatographic conditions (recommended)
5.4.1 Headspace conditions
a) Heating box temperature. 90℃;
b) Heating time. 30min.
5.4.2 Chromatographic conditions
a) Capillary column. 6% cyanopropyl phenyl-94% dimethyl polysiloxane (30m×0.25mm×1.4μm) or equivalent color
Spectrum column;
Note. If an equivalent column is used, the chromatographic conditions may be inconsistent.
b) Inlet temperature. 250℃;
c) Injection volume. 1mL; Split ratio. 5.1;
d) Oven temperature. hold at 50°C for 3min, heat up to 100°C at a rate of 10°C/min, hold for 2min;
e) Flow rate. 1.5mL/min; Carrier gas. N2;
f) Detector. FID; temperature. 300℃.
5.5 Measurement and result analysis
5.5.1 Preparation of test solution
Take the complete product or representative parts for the test, cut into 0.5cm long pieces (or 10mm2 flakes), take 1.0g into 20mL
In the headspace bottle, precisely add 5 mL of water, seal, and equilibrate at 90°C for 30 min.
5.5.2 Determination of standard solutions and samples
Take 5mL each of the prepared standard solution and the prepared test solution, place them in a 20mL headspace bottle and seal them according to the headspace conditions and chromatography
Condition determination.
5.5.3 Quantitative analysis
The external standard method is used to analyze the working standard solution and sample solution respectively, establish the working standard curve and regression equation, and calculate the sample
The residual amount of ECH. ECH residual content can be expressed in absolute content or relative content.
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