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YY/T 1507.4-2016Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants - Part 4: Determination of aluminium by ICP-MS (English PDF)

外科植入物用超高分子量聚乙烯粉料中杂质元素的测定第4部分:ICP-MS法测定铝(Al)元素含量

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1507.4-2016 is the English-translated version of 外科植入物用超高分子量聚乙烯粉料中杂质元素的测定第4部分:ICP-MS法测定铝(Al)元素含量.

YY/T 1507.4-2016 is the Chinese pharmaceutical industry standard that gives the inductively coupled plasma mass spectrometry method for determining aluminium in the ultra-high molecular weight polyethylene powder used in surgical implants.

It is the fourth part of the YY/T 1507 series and sets out the reagents, the digestion of the sample, the calibration and the measurement, and the calculation and reporting of the aluminium content. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1507.4-2016

National Standard of the People's Republic of China

Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative reference documents
  • 3 Principle
  • 4 Reagent
  • 5 Instruments
  • 6 Steps

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.

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 document. 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.

4.3 Aluminum (Al) standard solution. 1000 µg/mL (1 mol/L HNO3 medium).

4.2 Nitric acid (HNO3). mass fraction of 65%, electronic grade

.

5 Instruments

5.3 Analysis of balance.

5.2 Muffle furnace

5.1 Inductively Coupled Plasma Mass Spectrometer (ICP-MS)

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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