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YY/T 1507.1-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 1: Determination of titanium by ICP-MS
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| YY/T 1507.1-2016 | English | 119 |
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Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 1: Determination of titanium by ICP-MS
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YY/T 1507.1-2016
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Basic data | Standard ID | YY/T 1507.1-2016 (YY/T1507.1-2016) | | Description (Translated English) | Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 1: Determination of titanium by ICP-MS | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Word Count Estimation | 6,644 | | 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 of inductively coupled plasma mass spectrometry (ICP-MS) for the determination of titanium (Ti) elements in ultra-high molecular weight polyethylene powders. This standard is applicable to the determination of titanium (Ti) elements in ultra-high molecular weight polyethylene powders for surgical implants. | YY/T 1507.1-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 1: Determination of titanium 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 1. Determination of titanium by ICP-MS
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants with ultra high molecular weight polyethylene powder
Determination of impurity elements in materials - Part 1.
Determination of Titanium (Ti) Content by ICP - MS Method
ultra-highmolecularweightpolyethylenepowder-Part 1. Determination of
titaniumbyICP-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 1 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, the State Food and Drug Administration medical equipment technical review
center.
The main drafters of this part. Li Yuan, Jiang Xi, Ma Jinzhu, Fan Platinum, Liu Bin, Min Yue.
Surgical implants with ultra high molecular weight polyethylene powder
Determination of impurity elements in materials - Part 1.
Determination of Titanium (Ti) Content by ICP - MS Method
1 Scope
This part of YY/T 1507 specifies the determination of titanium in ultra-high molecular weight polyethylene powder by inductively coupled plasma mass spectrometry (ICP-MS)
(Ti) element.
This part is applicable to the determination of titanium (Ti) elements 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 (GB/T 6682-2008, ISO 3696. 1987, MOD)
3 principle
After the sample is digested by acid, the digestion liquid is atomized from the carrier gas (argon) into the ICP torch, and after evaporation, dissociation, atomization, electricity
From the process, 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
from. For a certain mass-to-charge ratio, the mass spectral integration area is proportional to the number of ions entering the mass spectrometer, that is, the concentration of the sample to be measured in the sample
Integral area or mass spectrum is proportional to high. The concentration of titanium (Ti) in the sample can therefore be determined by measuring the mass spectral area or the mass spectrum peak height.
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 Titanium Standard stock solution. 100 μg/mL (5% H2SO4 medium).
5 instruments
5.1 Inductively Coupled Plasma Mass Spectrometry (ICP-MS).
5.2 Microwave digestion system.
6 steps
6.1 Preparation of test solution
Accurately weigh 0.2 g of sample (accurate to 0.1 mg) in digestion tank, add 5 mL of nitric acid (see 4.2) and place in a microwave digestion system
5.2). Set the appropriate microwave digestion procedures (see Table 1), to be completely after the solution at 150 ℃ heating plate heated to near dry, water
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