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YY/T 1507.4-2016: Determination the content of impurity element in the implant for surgery ultra-igh molecular weight polyethylene powder--Part 4: Determination of aluminum by ICP-MS
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1507.4-2016 | English | 119 |
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Determination the content of impurity element in the implant for surgery ultra-igh molecular weight polyethylene powder--Part 4: Determination of aluminum by ICP-MS
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YY/T 1507.4-2016
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Basic data | Standard ID | YY/T 1507.4-2016 (YY/T1507.4-2016) | | Description (Translated English) | Determination the content of impurity element in the implant for surgery ultra-igh molecular weight polyethylene powder--Part 4: Determination of aluminum by ICP-MS | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Word Count Estimation | 6,683 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 6682 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the method for the determination of aluminum (Al) elements in ultra-high molecular weight polyethylene powders for surgical implants by inductively coupled plasma mass spectrometry (ICP-MS). This standard is applicable to the determination of aluminum (Al) in ultra high molecular weight polyethylene powders for surgical implants. | YY/T 1507.4-2016: Determination the content of impurity element in the implant for surgery ultra-igh molecular weight polyethylene powder--Part 4: Determination of aluminum by ICP-MS
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Determination of content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder - Part 4. Determination of aluminum by ICP-MS
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants are made of ultra high molecular weight polyethylene powder
Determination of impurity elements - Part 4.
Determination of Aluminum (Al) Content by ICP - MS Method
ultra-highmolecularweightpolyethylenepowder-Part 4. Determination of
aluminumbyICP-MS
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 1507 "Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants" is divided into the following four parts.
Part 1. Determination of titanium (Ti) content by ICP-MS method;
Part 2. Determination of Chlorine (Cl) Element Content by Ion Chromatography;
Part 3. Determination of calcium (Ca) content by ICP-MS method;
Part 4. Determination of aluminum (Al) content by ICP-MS method.
This part is part 4 of YY/T 1507.
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 issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This section is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110).
This part of the drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center.
This part of the main drafters. Li Yuan, Ma Jinzhu, Zhu Jinqing.
Surgical implants are made of ultra high molecular weight polyethylene powder
Determination of impurity elements - Part 4.
Determination of Aluminum (Al) Content by ICP - MS Method
1 Scope
YY/T 1507 of this part of the provisions of the Inductively Coupled Plasma Mass Spectrometry (ICP-MS) method for the determination of surgical implants with ultra-high molecular weight poly
Method for aluminum (Al) elements in vinyl powder.
This part applies to the determination of aluminum (Al) in ultra high molecular weight polyethylene powders for surgical implants.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 principle
After the sample was ashed, the residual solution was atomized by carrier gas (argon) into the inductively coupled plasma (ICP) torch.
Evaporation, dissociation, atomization, ionization and other processes, most of the conversion into a positively charged positive ions, the ion collection system into the mass spectrometer, mass spectrometer
According to its mass-to-charge ratio. For a certain mass-to-charge ratio, the mass spectral area or peak height is proportional to the number of ions entering the mass spectrometer, ie
The concentration of the sample to be measured in the sample is proportional to the mass spectral area or mass spectrum peak. So it can be measured by measuring the mass spectral area or mass spectrometry peak height measurement
The concentration of aluminum (Al) in the sample.
4 reagent
4.1 Except as otherwise provided, only reagents recognized as excellent grade pure or higher purity and primary water in accordance with GB/T 6682 are used.
4.2 nitric acid (HNO3). mass fraction of 65%, electronic grade.
4.3 Aluminum (Al) standard solution. 1000 μg/mL (1 mol/L HNO3 medium).
5 instruments
5.1 Inductively Coupled Plasma Mass Spectrometer (ICP-MS).
5.2 muffle furnace.
5.3 Analysis of balance.
6 steps
6.1 Preparation of test solution
Accurately weighed 1.0g sample (accurate to 0.1mg) in the quartz crucible, in a small electric furnace can be fired to smoke-free, and then moved into the horse
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