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YY/T 1550.2-2019

Chinese Standard: 'YY/T 1550.2-2019'
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YY/T 1550.2-2019English129 Add to Cart Days<=3 Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable known - Substance Valid YY/T 1550.2-2019
YY/T 1550.2-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 1550.2-2019 (YY/T1550.2-2019)
Description (Translated English) Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable known - Substance
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.30
Word Count Estimation 6,651
Date of Issue 2019-07-24
Date of Implementation 2020-08-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center
Administrative Organization National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC 106)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1550.2-2019
Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2. Leachable known - Substance
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
A one-time use infusion device and drug compatibility study guide
Part 2. Leachables research known
Guidanceofstudyonthecompatibilityofinfusionequipmentsandpharmaceutical
products-Part 2.Leachableknown-Substance
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
YY/T 1550 "Guidelines for the Study of Dispensable Infusion Appliances and Drug Compatibility" has been or is planned to be released
The following sections.
--- Part 1. Drug adsorption studies;
--- Part 2. Leachables research known;
--- Part 3. Leachables to study unknowns.
This part is the second part of YY/T 1550.
This part is 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 part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This part was drafted by Shandong Medical Device Product Quality Inspection Center, and Suzhou Baxter Medical Products Co., Ltd. participated in the drafting.
The main drafters of this section. Shen Yong, Luo Hongyu, Liu Juanhua, Xu Kai, Chen Fang.
introduction
Leachablesubstance of a medical device refers to a chemical released from a medical device during clinical use.
The general term for quality. Leachables studies are generally used for toxicological risk assessment, in addition to which some leachables may cause the characteristics of the drug to be infused
The change, therefore, in the study of leachables, the characteristics of the appearance of the extract should be investigated first.
The known leachables in this section refer to the raw materials of the disposable infusion device products and substances introduced or added during the production process.
The process may dissolve into the liquid medicine, such as plasticizer in the PVC infusion device, and the coloring agent in the light infusion device. Known for leachables
The establishment of objects can be obtained by.
1) Information on formula information, processing aid information, sterilizing agent (if any), etc.;
2) Literature studies on the nature of exposure to related routes of exposure.
Due to the wide variety of disposable infusion devices and drugs to be infused, and the different clinical applications of different infusion devices,
Therefore, for samples that cannot be prepared according to clinical use, simulated leaching or limiting leaching can be used for leachables.
The study of knowing things. Due to the wide variety of leachables, it is not possible in this section to provide an analytical method that is suitable for all leachables. Currently, often
The analytical methods used mainly include HPLC, LC-MS, GC-MS, GC, AAS and ICP-MS. The first four methods are mainly used for evaluation.
Machine leaching, the latter two methods are mainly used for inorganic migration, especially the qualitative and quantitative determination of metal elements. Known in leachables
At the time of the study, the methodology chosen should be thoroughly validated, including accuracy, precision, specificity, detection limits, limit of quantitation, linearity and
Range and durability, etc.
A one-time use infusion device and drug compatibility study guide
Part 2. Leachables research known
1 Scope
This section of YY/T 1550 gives a single-use infusion set under clinical infusion conditions or under simulated clinical infusion conditions.
A method of studying known substances in leachables during contact with a drug.
This section applies to specific infusion sets and drugs to be infused or known leachables of the simulated solvent selected for demonstration.
the study.
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 16886.12-2017 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials
People's Republic of China Pharmacopoeia.2015 Edition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Leachable leachablesubstance
A substance that can be released during clinical use of a medical device or material.
[GB/T 16886.12-2017, definition 3.10]
3.2
Extractables extractables
Can be released when a medical device or material is extracted with a solvent and/or leached under at least the same stringent conditions as expected for clinical use
The substance.
3.3
Simulated leaching simulated-useextraction
A simulated product used to evaluate the level of leaching material received by a patient or user during routine use of an instrument
The extraction method used.
Note. It is confirmed by the analytical laboratory that the simulated use of the leaching is performed under the most challenging conditions for the intended use. Method of simulating product use
Yes, considering the tissue to which the device is exposed, the contact temperature and the contact time, it is assumed to be the most stringent possible contact classification.
3.4
Limit extraction exhaustiveextraction
Subsequent extraction of the leachable material into the leachate is less than the 10% detectable amount of the first leach solution.
Note. It is not possible to completely recover the residual amount, so use the definition of limit leaching.
YY/T 1550.2-2019
Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2. Leachable known - Substance
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
A one-time use infusion device and drug compatibility study guide
Part 2. Leachables research known
Guidanceofstudyonthecompatibilityofinfusionequipmentsandpharmaceutical
products-Part 2.Leachableknown-Substance
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
YY/T 1550 "Guidelines for the Study of Dispensable Infusion Appliances and Drug Compatibility" has been or is planned to be released
The following sections.
--- Part 1. Drug adsorption studies;
--- Part 2. Leachables research known;
--- Part 3. Leachables to study unknowns.
This part is the second part of YY/T 1550.
This part is 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 part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This part was drafted by Shandong Medical Device Product Quality Inspection Center, and Suzhou Baxter Medical Products Co., Ltd. participated in the drafting.
The main drafters of this section. Shen Yong, Luo Hongyu, Liu Juanhua, Xu Kai, Chen Fang.
introduction
Leachablesubstance of a medical device refers to a chemical released from a medical device during clinical use.
The general term for quality. Leachables studies are generally used for toxicological risk assessment, in addition to which some leachables may cause the characteristics of the drug to be infused
The change, therefore, in the study of leachables, the characteristics of the appearance of the extract should be investigated first.
The known leachables in this section refer to the raw materials of the disposable infusion device products and substances introduced or added during the production process.
The process may dissolve into the liquid medicine, such as plasticizer in the PVC infusion device, and the coloring agent in the light infusion device. Known for leachables
The establishment of objects can be obtained by.
1) Information on formula information, processing aid information, sterilizing agent (if any), etc.;
2) Literature studies on the nature of exposure to related routes of exposure.
Due to the wide variety of disposable infusion devices and drugs to be infused, and the different clinical applications of different infusion devices,
Therefore, for samples that cannot be prepared according to clinical use, simulated leaching or limiting leaching can be used for leachables.
The study of knowing things. Due to the wide variety of leachables, it is not possible in this section to provide an analytical method that is suitable for all leachables. Currently, often
The analytical methods used mainly include HPLC, LC-MS, GC-MS, GC, AAS and ICP-MS. The first four methods are mainly used for evaluation.
Machine leaching, the latter two methods are mainly used for inorganic migration, especially the qualitative and quantitative determination of metal elements. Known in leachables
At the time of the study, the methodology chosen should be thoroughly validated, including accuracy, precision, specificity, detection limits, limit of quantitation, linearity and
Range and durability, etc.
A one-time use infusion device and drug compatibility study guide
Part 2. Leachables research known
1 Scope
This section of YY/T 1550 gives a single-use infusion set under clinical infusion conditions or under simulated clinical infusion conditions.
A method of studying known substances in leachables during contact with a drug.
This section applies to specific infusion sets and drugs to be infused or known leachables of the simulated solvent selected for demonstration.
the study.
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 16886.12-2017 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials
People's Republic of China Pharmacopoeia.2015 Edition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Leachable leachablesubstance
A substance that can be released during clinical use of a medical device or material.
[GB/T 16886.12-2017, definition 3.10]
3.2
Extractables extractables
Can be released when a medical device or material is extracted with a solvent and/or leached under at least the same stringent conditions as expected for clinical use
The substance.
3.3
Simulated leaching simulated-useextraction
A simulated product used to evaluate the level of leaching material received by a patient or user during routine use of an instrument
The extraction method used.
Note. It is confirmed by the analytical laboratory that the simulated use of the leaching is performed under the most challenging conditions for the intended use. Method of simulating product use
Yes, considering the tissue to which the device is exposed, the contact temperature and the contact time, it is assumed to be the most stringent possible contact classification.
3.4
Limit extraction exhaustiveextraction
Subsequent extraction of the leachable material into the leachate is less than the 10% detectable amount of the first leach solution.
Note. It is not possible to completely recover the residual amount, so use the definition of limit leaching.
Related standard:   YY/T 1550.1-2017  YY/T 1536-2017
Related PDF sample:   YY/T 1550.1-2017  YY/T 1566.1-2017
   
 
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