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YY/T 1507.3-2016 English PDF

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YY/T 1507.3-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 3: Determination of calcium by ICP-MS
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1507.3-2016	English	119	Add to Cart	3 days [Need to translate]	Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 3: Determination of calcium by ICP-MS	Valid	YY/T 1507.3-2016

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Basic data

Standard ID	YY/T 1507.3-2016 (YY/T1507.3-2016)
Description (Translated English)	Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 3: Determination of calcium by ICP-MS
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Word Count Estimation	6,697
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 calcium (Ca) elements in ultra-high molecular weight polyethylene powders for surgical implants. This standard is applicable to the determination of calcium (Ca) in ultra high molecular weight polyethylene powder for surgical implantation.

YY/T 1507.3-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 3: Determination of calcium by ICP-MS

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Determination of content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder - Part 3. Determination of calcium 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 3. ICP - MS method Determination of calcium (Ca) content ultra-highmolecularweightpolyethylenepowder-Part 3. Determination of calciumbyICP-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 3 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, Jiang Xi, Jing Ming. Surgical implants are made of ultra high molecular weight polyethylene powder Determination of impurity elements - Part 3. ICP - MS method Determination of calcium (Ca) content

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 Calcium (Ca) Elements in Ethylene Powders. This part applies to the determination of calcium (Ca) 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 calcium (Ca) 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 Calcium 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 the adjustable electric furnace on a small fire carbonized to smoke-free, and then moved into the horse

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