YY/T 1658-2019 PDF English
US$119.00 · In stock · Download in 9 secondsYY/T 1658-2019: Test method for cyclohexanone released from infusion and transfusion equipments for medical use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1658-2019 | English | 119 |
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Test method for cyclohexanone released from infusion and transfusion equipments for medical use
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YY/T 1658-2019: Test method for cyclohexanone released from infusion and transfusion equipments for medical use
---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/YYT1658-2019
Test method for cyclohexanone released from infusion and transfusion equipments for medical use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Cyclohexanone in infusion transfusion apparatus
Method for measuring the amount of dissolution
Testmethodforcyclohexanonereleasedfrominfusionand
Transfusionequipmentsformedicaluse
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization 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 Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Jiangsu Suyun Medical Equipment Co., Ltd., Chengdu Xinjin
Feng Medical Devices Co., Ltd., Shanghai Kangdelai Enterprise Development Group Co., Ltd.
The main drafters of this standard. Shen Yong, Wang Shuhua, Tian Xinglong, Gao Yizhen, Liu Aijuan.
introduction
At present, most of the domestic disposable infusion and blood transfusion device components use cyclohexanone-based adhesives, and cyclohexanone is used in the formulation.
the Lord. Some enterprises directly draw cyclohexanone when they are bonded, and there will be an excess of cyclohexanone in the operation, so that a large number of rings remain in the tube wall and the inner cavity.
Hexanone.
The data indicate that cyclohexanone has a central nervous system inhibitory effect and a high concentration of cyclohexanone has an anesthetic effect. Cyclohexanone vapor on mucous membrane
It has a strong stimulating effect, and long-term skin contact with cyclohexanone liquid can cause skin irritation and severe conjunctival irritation.
At present, the national standards and industry standards for infusion and blood transfusion devices in China do not specify the limit requirements for cyclohexanone adhesives.
A variety of analytical methods can be used to determine the amount of cyclohexanone dissolved, typical methods include gas chromatography (GC), gas chromatography/mass spectrometry
Usage (GC/MS), etc. This standard uses top air phase chromatography as the basic method and gives the test procedure.
Although the type of adhesive used in infusion and blood transfusion apparatus is not limited to cyclohexanone, this standard only gives a method for measuring the amount of cyclohexanone dissolved. another
In addition, the clinical application of the device varies greatly. In some cases, the published literature methods include the methods given in this standard.
Not necessarily for all instruments. Therefore, any method that demonstrates reliable analysis can be used. “Reliable analysis” means that the device is specific
When the extraction liquid obtained under the leaching medium and the conditions is analyzed for the amount of cyclohexanone eluted, the selected method has sufficient precision, accuracy, and
Linearity, sensitivity and selectivity.
Cyclohexanone in infusion transfusion apparatus
Method for measuring the amount of dissolution
1 Scope
This standard specifies the method for determining the amount of cyclohexanone dissolved in infusion and blood transfusion equipment.
This standard applies to infusion and blood transfusion devices using cyclohexanone as a binder.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 General
3.1 The room temperature in this standard, if not specified, should be 10 ° C ~ 30 ° C.
3.2 The test water in this standard shall meet the requirements of GB/T 6682.
3.3 Containers used in this standard shall be borosilicate glass containers unless otherwise specified.
3.4 The precision measurement referred to in this standard shall be taken by pipettes that meet the accuracy requirements of the corresponding national standards.
4 Preparation of extract
4.1 General
For the preparation of extracts of cyclohexanone dissolved in medical devices using cyclohexanone as a binder, consideration should be given to the clinical use of the medical device.
The use conditions in the selection of suitable extraction liquid preparation methods, such as extraction solvent, time, temperature and mode of action.
It is advisable to demonstrate the preparation method of the extract to prove that the extraction conditions selected for the instrument represent the most important product brought to the patient in the intended use.
Big risk.
4.2 Screening and leaching
The sample was cut into 1 cm long sections, added to a glass container, water was added in a ratio of 0.2 g/mL, and sealed at 150 ° C/min at 37 ° C.
Shake for 24 h, then take a part of the extract as a test solution.
Note. If the screening test results exceed the maximum allowable dose of the human body, consider using the simulated extraction (4.3) to prepare the extract for further testing.
1) or other methodologically validated alternative fluids, such as the alternative solvent. water.
4.3 Simulated leaching
The leaching is carried out using the liquid 1) which is the most unfavorable clinical contact, and the leaching method and conditions, and then the part is taken.
The extract is used as a test solution.
Due to the large difference in the clinical use of the device, especially the actual contact medium of the infusion device is varied,
YY/T 1658-2019
Test method for cyclohexanone released from infusion and transfusion equipments for medical use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Cyclohexanone in infusion transfusion apparatus
Method for measuring the amount of dissolution
Testmethodforcyclohexanonereleasedfrominfusionand
Transfusionequipmentsformedicaluse
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization 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 Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Jiangsu Suyun Medical Equipment Co., Ltd., Chengdu Xinjin
Feng Medical Devices Co., Ltd., Shanghai Kangdelai Enterprise Development Group Co., Ltd.
The main drafters of this standard. Shen Yong, Wang Shuhua, Tian Xinglong, Gao Yizhen, Liu Aijuan.
introduction
At present, most of the domestic disposable infusion and blood transfusion device components use cyclohexanone-based adhesives, and cyclohexanone is used in the formulation.
the Lord. Some enterprises directly draw cyclohexanone when they are bonded, and there will be an excess of cyclohexanone in the operation, so that a large number of rings remain in the tube wall and the inner cavity.
Hexanone.
The data indicate that cyclohexanone has a central nervous system inhibitory effect and a high concentration of cyclohexanone has an anesthetic effect. Cyclohexanone vapor on mucous membrane
It has a strong stimulating effect, and long-term skin contact with cyclohexanone liquid can cause skin irritation and severe conjunctival irritation.
At present, the national standards and industry standards for infusion and blood transfusion devices in China do not specify the limit requirements for cyclohexanone adhesives.
A variety of analytical methods can be used to determine the amount of cyclohexanone dissolved, typical methods include gas chromatography (GC), gas chromatography/mass spectrometry
Usage (GC/MS), etc. This standard uses top air phase chromatography as the basic method and gives the test procedure.
Although the type of adhesive used in infusion and blood transfusion apparatus is not limited to cyclohexanone, this standard only gives a method for measuring the amount of cyclohexanone dissolved. another
In addition, the clinical application of the device varies greatly. In some cases, the published literature methods include the methods given in this standard.
Not necessarily for all instruments. Therefore, any method that demonstrates reliable analysis can be used. “Reliable analysis” means that the device is specific
When the extraction liquid obtained under the leaching medium and the conditions is analyzed for the amount of cyclohexanone eluted, the selected method has sufficient precision, accuracy, and
Linearity, sensitivity and selectivity.
Cyclohexanone in infusion transfusion apparatus
Method for measuring the amount of dissolution
1 Scope
This standard specifies the method for determining the amount of cyclohexanone dissolved in infusion and blood transfusion equipment.
This standard applies to infusion and blood transfusion devices using cyclohexanone as a binder.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 General
3.1 The room temperature in this standard, if not specified, should be 10 ° C ~ 30 ° C.
3.2 The test water in this standard shall meet the requirements of GB/T 6682.
3.3 Containers used in this standard shall be borosilicate glass containers unless otherwise specified.
3.4 The precision measurement referred to in this standard shall be taken by pipettes that meet the accuracy requirements of the corresponding national standards.
4 Preparation of extract
4.1 General
For the preparation of extracts of cyclohexanone dissolved in medical devices using cyclohexanone as a binder, consideration should be given to the clinical use of the medical device.
The use conditions in the selection of suitable extraction liquid preparation methods, such as extraction solvent, time, temperature and mode of action.
It is advisable to demonstrate the preparation method of the extract to prove that the extraction conditions selected for the instrument represent the most important product brought to the patient in the intended use.
Big risk.
4.2 Screening and leaching
The sample was cut into 1 cm long sections, added to a glass container, water was added in a ratio of 0.2 g/mL, and sealed at 150 ° C/min at 37 ° C.
Shake for 24 h, then take a part of the extract as a test solution.
Note. If the screening test results exceed the maximum allowable dose of the human body, consider using the simulated extraction (4.3) to prepare the extract for further testing.
1) or other methodologically validated alternative fluids, such as the alternative solvent. water.
4.3 Simulated leaching
The leaching is carried out using the liquid 1) which is the most unfavorable clinical contact, and the leaching method and conditions, and then the part is taken.
The extract is used as a test solution.
Due to the large difference in the clinical use of the device, especially the actual contact medium of the infusion device is varied,
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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